Adapting Behavioral Interventions for Social Media Delivery.

Science.gov (United States)

Pagoto, Sherry; Waring, Molly E; May, Christine N; Ding, Eric Y; Kunz, Werner H; Hayes, Rashelle; Oleski, Jessica L

2016-01-29

Patients are increasingly using online social networks (ie, social media) to connect with other patients and health care professionals--a trend called peer-to-peer health care. Because online social networks provide a means for health care professionals to communicate with patients, and for patients to communicate with each other, an opportunity exists to use social media as a modality to deliver behavioral interventions. Social media-delivered behavioral interventions have the potential to reduce the expense of behavioral interventions by eliminating visits, as well as increase our access to patients by becoming embedded in their social media feeds. Trials of online social network-delivered behavioral interventions have shown promise, but much is unknown about intervention development and methodology. In this paper, we discuss the process by which investigators can translate behavioral interventions for social media delivery. We present a model that describes the steps and decision points in this process, including the necessary training and reporting requirements. We also discuss issues pertinent to social media-delivered interventions, including cost, scalability, and privacy. Finally, we identify areas of research that are needed to optimize this emerging behavioral intervention modality.

Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial.

Science.gov (United States)

Howren, M Bryant; Kellerman, Quinn D; Hillis, Stephen L; Cvengros, Jamie; Lawton, William; Christensen, Alan J

2016-04-01

The purpose of this study is to evaluate the efficacy of a behavioral self-regulation intervention vs. active control condition using a parallel-group randomized clinical trial with a sample of center hemodialysis patients with chronic kidney disease. Participants were recruited from 8 hemodialysis treatment centers in the Midwest. Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5 kg over a 4-week period, (b) >18 years of age, (c) English-speaking without severe cognitive impairment, (d) treated with center-based hemodialysis for >3 months, and (e) not living in a care facility in which meals were managed. Medical records were used to identify eligible patients. Patients were randomly assigned to either a behavioral self-regulation intervention or active control condition in which groups of 3-8 patients met for hour-long, weekly sessions for 7 weeks at their usual hemodialysis clinic. Primary analyses were intention-to-treat. Sixty-one patients were randomized to the intervention while 58 were assigned to the attention-placebo support and discussion control. Covariate-adjusted between-subjects analyses demonstrated no unique intervention effect for the primary outcome, interdialytic weight gain (β = 0.13, p = 0.48). Significant within-subjects improvement over time was observed for the intervention group (β = -0.32, p = 0.014). The present study found that participation in a behavioral self-regulation intervention resulted in no unique intervention effect on a key indicator of adherence for those with severe chronic kidney disease. There was, however, modest within-subjects improvement in interdialytic weight gain for the intervention group which meshes with other evidence showing the utility of behavioral interventions in this patient population. ClinicalTrials.gov Identifier: NCT01066949.

A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial.

Science.gov (United States)

Janssen, Ellen M; Jerome, Gerald J; Dalcin, Arlene T; Gennusa, Joseph V; Goldsholl, Stacy; Frick, Kevin D; Wang, Nae-Yuh; Appel, Lawrence J; Daumit, Gail L

2017-06-01

In the ACHIEVE randomized controlled trial, an 18-month behavioral intervention accomplished weight loss in persons with serious mental illness who attended community psychiatric rehabilitation programs. This analysis estimates costs for delivering the intervention during the study. It also estimates expected costs to implement the intervention more widely in a range of community mental health programs. Using empirical data, costs were calculated from the perspective of a community psychiatric rehabilitation program delivering the intervention. Personnel and travel costs were calculated using time sheet data. Rent and supply costs were calculated using rent per square foot and intervention records. A univariate sensitivity analysis and an expert-informed sensitivity analysis were conducted. With 144 participants receiving the intervention and a mean weight loss of 3.4 kg, costs of $95 per participant per month and $501 per kilogram lost in the trial were calculated. In univariate sensitivity analysis, costs ranged from $402 to $725 per kilogram lost. Through expert-informed sensitivity analysis, it was estimated that rehabilitation programs could implement the intervention for $68 to $85 per client per month. Costs of implementing the ACHIEVE intervention were in the range of other intensive behavioral weight loss interventions. Wider implementation of efficacious lifestyle interventions in community mental health settings will require adequate funding mechanisms. © 2017 The Obesity Society.

A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

Directory of Open Access Journals (Sweden)

Schuengel Carlo

2011-07-01

Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

A Randomized Clinical Trial Comparison Between Pivotal Response Treatment (PRT) and Adult-Driven Applied Behavior Analysis (ABA) Intervention on Disruptive Behaviors in Public School Children with Autism.

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Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaei, Mohammad; Bakhshi, Enayatolah

2015-09-01

Children with autism often demonstrate disruptive behaviors during demanding teaching tasks. Language intervention can be particularly difficult as it involves social and communicative areas, which are challenging for this population. The purpose of this study was to compare two intervention conditions, a naturalistic approach, Pivotal Response Treatment (PRT) with an adult-directed ABA approach on disruptive behavior during language intervention in the public schools. A randomized clinical trial design was used with two groups of children, matched according to age, sex and mean length of utterance. The data showed that the children demonstrated significantly lower levels of disruptive behavior during the PRT condition. The results are discussed with respect to antecedent manipulations that may be helpful in reducing disruptive behavior.

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

Science.gov (United States)

Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

2015-11-01

To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

Science.gov (United States)

Modi, Riddhi A; Mugavero, Michael J; Amico, Rivet K; Keruly, Jeanne; Quinlivan, Evelyn Byrd; Crane, Heidi M; Guzman, Alfredo; Zinski, Anne; Montue, Solange; Roytburd, Katya; Church, Anna; Willig, James H

2017-06-16

Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user

Expanding the scope and relevance of health interventions: Moving beyond clinical trials and behavior change models

Directory of Open Access Journals (Sweden)

Khary K. Rigg

2014-07-01

Full Text Available An overemphasis on clinical trials and behavior change models has narrowed the knowledge base that can be used to design interventions. The overarching point is that the process of overanalyzing variables is impeding the process of gaining insight into the everyday experiences that shape how people define health and seek treatment. This claim is especially important to health decision-making and behavior change because subtle interpretations often influence the decisions that people make. This manuscript provides a critique of traditional approaches to developing health interventions, and theoretically justifies what and why changes are warranted. The limited scope of these models is also discussed, and an argument is made to adopt a strategy that includes the perceptions of people as necessary for understanding health and health-related decision-making. Three practical strategies are suggested to be used with the more standard approaches to assessing the effectiveness and relevance of health interventions.

PREVIEW Behavior Modification Intervention Toolbox (PREMIT)

DEFF Research Database (Denmark)

Kahlert, Daniela; Unyi-Reicherz, Annelie; Stratton, Gareth

2016-01-01

and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counseling approach. METHODS: The program...... development took five progressive steps, in line with the Public Health Action Cycle: (1) Summing-up the intervention goal(s), target group and the setting, (2) uncovering the generative psychological mechanisms, (3) identifying behavior change techniques and tools, (4) preparing for evaluation and (5...

SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial.

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Song, Mi-Kyung; Ward, Sandra E; Hepburn, Kenneth; Paul, Sudeshna; Shah, Raj C; Morhardt, Darby J

2018-06-02

People in the early stages of Alzheimer's disease and related dementias (ADRD) are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate. In this NIH Stage I behavioral intervention development trial, we will adapt and test an efficacious ACP intervention, SPIRIT (Sharing Patient's Illness Representation to Increase Trust), with people with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. We will first adapt SPIRIT (in person) to target people with mild dementia and their surrogates through a process of modification-pretesting-refinement using stakeholders (persons with mild dementia, family caregivers, and clinicians) and experts, including adapting the delivery mode to interactive web-based videoconference format (SPIRIT-remote). Then in a 3-group RCT with 120 patient-surrogate dyads, we will evaluate the feasibility and acceptability of SPIRIT in-person and SPIRIT remote, and preliminary efficacy of SPIRIT compared to usual care on preparedness outcomes for end-of-life decision making (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) shortly after the intervention. This Stage I research of SPIRIT will generate valuable insights regarding how to improve ACP for people with mild dementia who will progress to an advanced stage of the disease in the foreseeable future. ClinicalTrials.gov NCT03311711, Registered 10/12/2017. Copyright © 2018. Published by Elsevier Inc.

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

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Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Behavioral interventions for improving dual-method contraceptive use.

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Lopez, Laureen M; Stockton, Laurie L; Chen, Mario; Steiner, Markus J; Gallo, Maria F

2014-03-30

Dual-method contraception refers to using condoms as well as another modern method of contraception. The latter (usually non-barrier) method is commonly hormonal (e.g., oral contraceptives) or a non-hormonal intrauterine device. Use of two methods can better prevent pregnancy and the transmission of HIV and other sexually transmitted infections (STIs) compared to single-method use. Unprotected sex increases risk for disease, disability, and mortality in many areas due to the prevalence and incidence of HIV/STI. Millions of women, especially in lower-resource areas, also have an unmet need for protection against unintended pregnancy. We examined comparative studies of behavioral interventions for improving use of dual methods of contraception. Dual-method use refers to using condoms as well as another modern contraceptive method. Our intent was to identify effective interventions for preventing pregnancy as well as HIV/STI transmission. Through January 2014, we searched MEDLINE, CENTRAL, POPLINE, EMBASE, COPAC, and Open Grey. In addition, we searched ClinicalTrials.gov and ICTRP for current trials and trials with relevant data or reports. We examined reference lists of pertinent papers, including review articles, for additional reports. Studies could be either randomized or non-randomized. They examined a behavioral intervention with an educational or counseling component to encourage or improve the use of dual methods, i.e., condoms and another modern contraceptive. The intervention had to address preventing pregnancy as well as the transmission of HIV/STI. The program or service could be targeted to individuals, couples, or communities. The comparison condition could be another behavioral intervention to improve contraceptive use, usual care, other health education, or no intervention.Studies had to report use of dual methods, i.e., condoms plus another modern contraceptive method. We focused on the investigator's assessment of consistent dual-method use or use at

Behavioral interventions for improving condom use for dual protection.

Science.gov (United States)

Lopez, Laureen M; Otterness, Conrad; Chen, Mario; Steiner, Markus; Gallo, Maria F

2013-10-26

Unprotected sex is a major risk factor for disease, disability, and mortality in many areas of the world due to the prevalence and incidence of sexually transmitted infections (STI) including HIV. The male condom is one of the oldest contraceptive methods and the earliest method for preventing the spread of HIV. When used correctly and consistently, condoms can provide dual protection, i.e., against both pregnancy and HIV/STI. We examined comparative studies of behavioral interventions for improving condom use. We were interested in identifying interventions associated with effective condom use as measured with biological assessments, which can provide objective evidence of protection. Through September 2013, we searched computerized databases for comparative studies of behavioral interventions for improving condom use: MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, OpenGrey, COPAC, ClinicalTrials.gov, and ICTRP. We wrote to investigators for missing data. Studies could be either randomized or nonrandomized. They examined a behavioral intervention for improving condom use. The comparison could be another behavioral intervention, usual care, or no intervention. The experimental intervention had an educational or counseling component to encourage or improve condom use. It addressed preventing pregnancy as well as the transmission of HIV/STI. The focus could be on male or female condoms and targeted to individuals, couples, or communities. Potential participants included heterosexual women and heterosexual men.Studies had to provide data from test results or records on a biological outcome: pregnancy, HIV/STI, or presence of semen as assessed with a biological marker, e.g., prostate-specific antigen. We did not include self-reported data on protected or unprotected sex, due to the limitations of recall and social desirability bias. Outcomes were measured at least three months after the behavioral intervention started. Two authors evaluated abstracts for eligibility and

Impact of a Behavioral Sleep Intervention on New School Entrants' Social Emotional Functioning and Sleep: A Translational Randomized Trial.

Science.gov (United States)

Hiscock, Harriet; Quach, Jon; Paton, Kate; Peat, Rebecca; Gold, Lisa; Arnup, Sarah; Sia, Kah-Ling; Nicolaou, Elizabeth; Wake, Melissa

2018-05-14

Determine the effects and costs of a brief behavioral sleep intervention, previously shown to improve child social-emotional functioning, sleep, and parent mental health, in a translational trial. Three hundred thirty-four school entrant children from 47 primary schools in Melbourne, Australia, with parent-reported moderate to severe behavioral sleep problems. intervention group received sleep hygiene practices and standardized behavioral strategies delivered by trained school nurses in 2013 and 2014. Control group children could receive usual community care. Outcome measures: child social-emotional functioning (Pediatric Quality of Life Inventory 4.0 psychosocial health summary score-primary outcome), sleep problems (parent-reported severity, Children's Sleep Habits Questionnaire), behavior, academic function, working memory, child and parent quality of life, and parent mental health. At six months post randomization, 145 (of 168) intervention and 155 (of 166) control families completed the primary outcome for which there was no difference. Intervention compared with control children had fewer sleep problems (35.2% vs. 52.7% respectively, OR 0.5; 95% CI 0.3 to 0.8, p = 0.002) and better sleep patterns (e.g., longer sleep duration). Their parents reported fewer symptoms of depression. All differences attenuated by 12 months. There was no difference in other outcomes at either time point. Intervention costs: $AUS 182/child. A brief behavioral sleep intervention, delivered by school nurses to children with behavioral sleep problems, does not improve social emotional functioning. Benefits to child sleep and parent mental health are evident at 6 but not 12 months. Approaches that increase intervention dosage may improve outcomes.

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial.

Science.gov (United States)

Haugland, Bente Storm Mowatt; Raknes, Solfrid; Haaland, Aashild Tellefsen; Wergeland, Gro Janne; Bjaastad, Jon Fauskanger; Baste, Valborg; Himle, Joe; Rapee, Ron; Hoffart, Asle

2017-03-04

Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention. The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure. The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services. ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

Randomized controlled clinical trial of behavioral lifestyle intervention with partial meal replacement to reduce excessive gestational weight gain.

Science.gov (United States)

Phelan, Suzanne; Wing, Rena R; Brannen, Anna; McHugh, Angelica; Hagobian, Todd A; Schaffner, Andrew; Jelalian, Elissa; Hart, Chantelle N; Scholl, Theresa O; Munoz-Christian, Karen; Yin, Elaine; Phipps, Maureen G; Keadle, Sarah; Abrams, Barbara

2018-02-01

Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking. A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care. Participants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257). The intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (β = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P meal replacement significantly reduced GWG in Hispanic

Motives for (not) participating in a lifestyle intervention trial

DEFF Research Database (Denmark)

Lakerveld, J.; IJzelenberg, W.; van Tulder, M.

2008-01-01

: the perception of being unhealthy and willingness to change their lifestyle. The main barriers reported by non-participants were financial arguments and time investment. Conclusion. The differences between participants and non-participants in a lifestyle intervention trial are in mainly demographic factors......Background. Non-participants can have a considerable influence on the external validity of a study. Therefore, we assessed the socio-demographic, health-related, and lifestyle behavioral differences between participants and non-participants in a comprehensive CVD lifestyle intervention trial......, and explored the motives and barriers underlying the decision to participate or not. Methods. We collected data on participants (n = 50) and non-participants (n = 50) who were eligible for inclusion in a comprehensive CVD lifestyle interventional trial. Questionnaires and a hospital patient records database...

An Internet-Based Intervention to Promote Alcohol-Related Attitudinal and Behavioral Change Among Adolescents: Protocol of a Cluster Randomized Controlled Trial.

Science.gov (United States)

Ip, Patrick; Chan, Ko-Ling; Chow, Chun-Bong; Lam, Tai-Hing; Ho, Sai-Yin; Wong, Wilfred Hing-Sang; Wong, Margaret Fung-Yee

2016-06-01

Underage drinking is a prevalent risk behavior and common public health problem. Research shows that alcohol abuse not only affects the quality of life of drinkers themselves. The problems resulting from underage drinking pose substantial costs to society as well. The proposed study will address underage drinking with the use of an Internet campaign, which is a cost-effective way of tackling the problem. The aims of this study are to test the effectiveness of an online quiz competition in changing adolescents' alcohol-related attitudes and behavior and to explore the feasibility of using Internet viral marketing to reach a significant number of adolescents. The study will constitute a cluster randomized controlled trial for 20 secondary schools (6720 Grade 7-9 students). Schools will be randomized to intervention or control arm with equal likelihood. Students in intervention schools will be invited to take part in the Internet campaign, whereas those in control schools will receive relevant promotional leaflets. Alcohol-related attitude and behavior will be the primary outcome measures. The results of the proposed study will provide evidence on the efficacy of an Internet intervention in modifying adolescents' attitudes and behavior and guide further investigation into the prevention of and intervention in such risk behaviors as underage drinking. The project was funded July 2015, enrollment started September 2015, and results are expected July 2017. With the Internet increasingly being recognized as a practical and cost-effective platform for health information delivery, the proposed Internet-based intervention is expected to be more effective in altering adolescents' alcohol-related attitudes and behaviors than traditional health promotion. ClinicalTrials.gov NCT02450344; https://clinicaltrials.gov/ct2/show/NCT02450344 (Archived by WebCite at http://www.webcitation.org/6heB2zMBD).

A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial.

Science.gov (United States)

Hughes, Brenna L; Gans, Kim M; Raker, Christina; Hipolito, Evelyn R; Rouse, Dwight J

2017-10-01

To estimate the effects of a brief prenatal behavioral intervention on risk behaviors for maternal cytomegalovirus (CMV) infection. Women were screened with CMV serology during prenatal care before 20 weeks of gestation and followed for at least 10 weeks. Women without serologic evidence of primary CMV infection were approached. Participants were apprised of serostatus and then randomized 2:1 to either a brief behavioral intervention during their prenatal care visit or to standard care (a brochure). The 7- to 10-minute in-office intervention included a video and hygiene education using motivational interviewing. Participants were then given a reminder calendar to take home and weekly text message reminders. The primary outcome was change in behavioral compliance score on a scale of 0-100. Secondary outcomes included process evaluation and domains of behavior change. A sample size of 180 participants was planned to compare the behavioral compliance score change of at least 15% between intervention and control groups with 80% power and 2.5% two-sided α. From April 2013 to October 2014, 197 women were randomized. One hundred eighty-seven (96%) had outcome data available. Mean gestational age at screening and randomization was 9 4/7 and 13 6/7 weeks of gestation, respectively. Primary outcome assessment occurred at a mean of 28 4/7 weeks of gestation. Baseline behavioral compliance scores increased modestly in the intervention group (mean: 7-point increase from 80.7 to 87.7, 95% CI 2.4-5.9) compared with the comparison group (mean: 4-point increase from 79.7 to 84.1, 95% CI 5.9-8.4; mean difference in change score: 3.0, 95% CI, 0.8-5.2; P=.007). Those in the intervention group reported change in risk perception related to perceived severity and susceptibility, self-efficacy, and perceived norms (Pbehavioral intervention delivered in the prenatal care setting was modestly effective at changing behaviors related to CMV infection risk. ClinicalTrials.gov, NCT01819519.

Theory of planned behavior interventions for reducing heterosexual risk behaviors: A meta-analysis.

Science.gov (United States)

Tyson, Mandy; Covey, Judith; Rosenthal, Harriet E S

2014-12-01

The meta-analysis reported here examined interventions informed by the theory of planned behavior (TPB) or theory of reasoned action (TRA) aimed at reducing heterosexual risk behaviors (prevention of STDs and unwanted pregnancy). Studies were eligible for inclusion if they were either randomized control trials or quasi-experimental studies that compared the TPB-based intervention against a control group. Search strategy consisted of articles identified in previous reviews, keyword search through search engines, examination of key journals, and contacting key experts. Forty-seven intervention studies were included in the meta-analysis. Random effects models revealed that pooled effect sizes for TPB-based interventions had small but significant effects on behavior and other secondary outcomes (i.e., knowledge, attitudes, normative beliefs, perceived behavioral control, and intentions). Significant heterogeneity found between effect sizes was explored using metaregression. Larger effects were found for interventions that provided opportunities for social comparison. The TPB provides a valuable framework for designing interventions to change heterosexual risk behaviors. However, effect sizes varied quite substantially between studies, and further research is needed to explore the reasons why.

Microrandomized trials: An experimental design for developing just-in-time adaptive interventions.

Science.gov (United States)

Klasnja, Predrag; Hekler, Eric B; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A

2015-12-01

This article presents an experimental design, the microrandomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals' health behaviors. Microrandomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. The article describes the microrandomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Microrandomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Microrandomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions' effects, enabling creation of more effective JITAIs. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Comparing strategies to assess multiple behavior change in behavioral intervention studies.

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Drake, Bettina F; Quintiliani, Lisa M; Sapp, Amy L; Li, Yi; Harley, Amy E; Emmons, Karen M; Sorensen, Glorian

2013-03-01

Alternatives to individual behavior change methods have been proposed, however, little has been done to investigate how these methods compare. To explore four methods that quantify change in multiple risk behaviors targeting four common behaviors. We utilized data from two cluster-randomized, multiple behavior change trials conducted in two settings: small businesses and health centers. Methods used were: (1) summative; (2) z-score; (3) optimal linear combination; and (4) impact score. In the Small Business study, methods 2 and 3 revealed similar outcomes. However, physical activity did not contribute to method 3. In the Health Centers study, similar results were found with each of the methods. Multivitamin intake contributed significantly more to each of the summary measures than other behaviors. Selection of methods to assess multiple behavior change in intervention trials must consider study design, and the targeted population when determining the appropriate method/s to use.

Principles and strategies for monitoring data collection integrity in a multi-site randomized clinical trial of a behavioral intervention.

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Phillips-Salimi, Celeste R; Donovan Stickler, Molly A; Stegenga, Kristin; Lee, Melissa; Haase, Joan E

2011-08-01

Although treatment fidelity strategies for enhancing the integrity of behavioral interventions have been well described, little has been written about monitoring data collection integrity. This article describes the principles and strategies developed to monitor data collection integrity of the "Stories and Music for Adolescent/Young Adult Resilience During Transplant" study (R01NR008583, U10CA098543, and U10CA095861)-a multi-site Children's Oncology Group randomized clinical trial of a music therapy intervention for adolescents and young adults undergoing stem cell transplant. The principles and strategies outlined in this article provide one model for development and evaluation of a data collection integrity monitoring plan for behavioral interventions that may be adapted by investigators and may be useful to funding agencies and grant application reviewers in evaluating proposals. Copyright © 2011 Wiley Periodicals, Inc.

The effects of a brief intervention to promote walking on Theory of Planned Behavior constructs: a cluster randomized controlled trial in general practice.

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Williams, Stefanie L; Michie, Susan; Dale, Jeremy; Stallard, Nigel; French, David P

2015-05-01

Perceived behavioral control (PBC) is a consistent predictor of intentions to walk more. A previously successful intervention to promote walking by altering PBC has been adapted for delivery in general practice. This study aimed to evaluate the effect of this intervention on Theory of Planned Behavior (TPB) constructs in this context. Cluster randomized controlled trial, with n = 315 general practice patients. Practice nurses and Healthcare Assistants delivered a self-regulation intervention or information provision (control). Questionnaires assessed TPB variables at baseline, post-intervention, 6 weeks and 6 months. Walking was measured by pedometer. The control group reported significantly higher subjective norm at all follow-up time points. There were no significant differences between the two groups in PBC, intention, attitude or walking behavior. TPB variables significantly predicted intentions to walk more, but not objective walking behavior, after accounting for clustering. The lack of effect of the intervention was probably due to a failure to maintain intervention fidelity, and the unsuitability of the behavior change techniques included in the intervention for the population investigated. This previously successful intervention was not successful when delivered in this context, calling into question whether practice nurses are best placed to deliver such interventions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Early-Life Obesity Prevention: Critique of Intervention Trials During the First One Thousand Days.

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Reilly, John J; Martin, Anne; Hughes, Adrienne R

2017-06-01

To critique the evidence from recent and ongoing obesity prevention interventions in the first 1000 days in order to identify evidence gaps and weaknesses, and to make suggestions for more informative future intervention trials. Completed and ongoing intervention trials have had fairly modest effects, have been limited largely to high-income countries, and have used relatively short-term interventions and outcomes. Comparison of the evidence from completed prevention trials with the evidence from systematic reviews of behavioral risk factors shows that some life-course stages have been neglected (pre-conception and toddlerhood), and that interventions have neglected to target some important behavioral risk factors (maternal smoking during pregnancy, infant and child sleep). Finally, while obesity prevention interventions aim to modify body composition, few intervention trials have used body composition measures as outcomes, and this has limited their sensitivity to detect intervention effects. The new WHO Healthy Lifestyles Trajectory (HeLTI) initiative should address some of these weaknesses. Future early obesity prevention trials should be much more ambitious. They should, ideally: extend their interventions over the first 1000 days; have longer-term (childhood) outcomes, and improved outcome measures (body composition measures in addition to proxies for body composition such as the BMI for age); have greater emphasis on maternal smoking and child sleep; be global.

Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

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Orla Doyle

Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

Neighborhood effects in a behavioral randomized controlled trial.

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Pruitt, Sandi L; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

2014-11-01

Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Design, Intervention Fidelity, and Behavioral Outcomes of a School-Based Water, Sanitation, and Hygiene Cluster-Randomized Trial in Laos

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Anna N. Chard

2018-03-01

Full Text Available Evidence of the impact of water, sanitation, and hygiene (WASH in schools (WinS interventions on pupil absence and health is mixed. Few WinS evaluations rigorously report on output and outcome measures that allow for comparisons of effectiveness between interventions to be made, or for an understanding of why programs succeed. The Water, Sanitation, and Hygiene for Health and Education in Laotian Primary Schools (WASH HELPS study was a randomized controlled trial designed to measure the impact of the United Nations Children’s Fund (UNICEF Laos WinS project on child health and education. We also measured the sustainability of intervention outputs and outcomes, and analyzed the effectiveness of group hygiene activities on behavior change and habit formation. Here, we present the design and intermediate results from this study. We found the WinS project improved the WASH environment in intervention schools; 87.8% of schools received the intervention per design. School-level adherence to outputs was lower; on average, schools met 61.4% of adherence-related criteria. The WinS project produced positive changes in pupils’ school WASH behaviors, specifically increasing toilet use and daily group handwashing. Daily group hygiene activities are effective strategies to improve school WASH behaviors, but a complementary strategy needs to be concurrently promoted for effective and sustained individual handwashing practice at critical times.

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

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Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

2015-09-11

Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

Group Cognitive-Behavior Therapy and Supportive Art and Sport Interventions on Bam Earthquake Related Post Traumatic Stress Symptoms in Children: A Field Trial

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Narges Joshaghani

2009-12-01

Full Text Available "n Objective: "n "nThe main objective of this study is to evaluate the effect of psychological therapies and art/sport supportive interventions separately,and in combination on post traumatic stress symptoms in children and compare them with a control group . "nMethods: In a field trial, we evaluated the efficacy of group behavioral therapy, art and sport supportive interventions in Bam earthquake children survivors with PTSD symptoms and compared it with a control group. Before and after interventions we evaluated the PTSD symptoms using K-SADS-PL semi-structural interview for each group and compared them using appropriate statistical methods. "nResults: The participants were 200 individuals who were randomized in four groups according to an intervention program including: Group behavioral therapy; Group behavioral therapy plus art and sport interventions; Art and sport interventions; and control group. During the interventions, 39 individuals were excluded. None of the participants had severed PTSD or other psychiatry disorders that needed pharmacological interventions. In interventional groups, the reduction of total PTSD symptoms and the symptoms of re-experience, avoidance and hyper arousal was not statistically significant. However, in the control group, the PTSD symptoms increased during the study which was statistically significant. "nConclusion: Group behavior therapy and supportive interventions (art and sport may have preventive effects on PTSD symptoms.

Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

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Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

2014-01-01

Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews...... but never in meta-analyses specifically regarding cannabis use. Methods: PubMed, PsycINFO, EMBASE, and The Cochrane Central Register of Controlled Trials were searched using predefined search terms. We included randomized trials of all types of interventions targeting cannabis use disorders in patients...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...

An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group.

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Gordon Mansergh

2010-08-01

Full Text Available Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM, and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.Participants (n = 1,686 were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p0.05 from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86-1.51, nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk

The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial.

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Hartin, Phillip J; Nugent, Chris D; McClean, Sally I; Cleland, Ian; Tschanz, JoAnn T; Clark, Christine J; Norton, Maria C

2016-08-02

Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke "Gray Matters" mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user's performance, calculated from reported behaviors against recommended guidelines. This paper explores the rationale for a mobile phone-led intervention and details the app's effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=-3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly better in attaining their recommended daily goals

Adolescent survivors: a secondary analysis of a clinical trial targeting behavior change.

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Cox, Cheryl L; McLaughlin, Rosemary A; Rai, Shesh N; Steen, Brenda D; Hudson, Melissa M

2005-08-01

The late effects of radiation and chemotherapy increase childhood cancer survivors' risk of chronic health problems. Survivors' behavior is important in modifying this risk, yet adolescent and young adult survivors fail to engage in important health-promoting behaviors and frequently practice high-risk behaviors. This secondary analysis re-evaluated a multi-component behavior-change intervention that had previously demonstrated no impact in adolescent survivors of childhood cancer. The parent trial compared 132 adolescent survivors in the intervention arm with 135 in the standard-care arm at baseline and at 1 year for disease and treatment knowledge, perception of late effects risk, and the frequency of health-risk and health-protective behaviors (combined as a single summative measure). In contrast, the secondary analysis examined each of the 14 behaviors separately. Additionally, an analysis of covariance (ANCOVA) was conducted to examine the change in health behaviors while statistically controlling for age, gender, and the wide variation in baseline behaviors. Knowledge (P = 0.038), breast self-examination (BSE) (P junk food consumption decreased (P = 0.052) and smoking abstinence was maintained (P = 0.088). Significant interactions between gender and treatment group were demonstrated. Health-risk and health-protective behaviors cannot be effectively combined in a one-dimensional measure. Gender and age influence the impact of interventions targeting health behavior in survivors. Future trials should include observation of the patient-clinician encounter, more complex sampling methods, and pre-trial knowledge of the distribution of the study behaviors.

Experimental Evidence for Differential Susceptibility: Dopamine D4 Receptor Polymorphism (DRD4 VNTR) Moderates Intervention Effects on Toddlers' Externalizing Behavior in a Randomized Controlled Trial

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Bakermans-Kranenburg, Marian J.; Van Ijzendoorn, Marinus H.; Pijlman, Femke T. A.; Mesman, Judi; Juffer, Femmie

2008-01-01

In a randomized controlled trial we tested the role of genetic differences in explaining variability in intervention effects on child externalizing behavior. One hundred fifty-seven families with 1- to 3-year-old children screened for their relatively high levels of externalizing behavior participated in a study implementing Video-feedback…

Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial.

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Elsas, S M; Gregory, W L; White, G; Navarro, G; Salinsky, M C; Andrews, D J

2011-12-01

Patients with epilepsy frequently experience depression and emotional stress and these may function as seizure triggers in epileptogenic frontotemporal cortex, which serves in emotional processing. Eight patients enrolled in a pilot trial of a 6-month epilepsy-specific behavioral approach comprising counseling and relaxation to recognize and eliminate emotional seizure triggers. Potential participants with psychogenic seizures were excluded by long-term EEG and/or the MMPI profile. One participant became seizure free, another had an approximately 90% reduction in seizures, and two additional participants achieved a greater than 50% reduction in seizure frequency (total responder rate=50%), stable during 6 months of observation after the intervention. All completers showed marked and stable improvement of quality of life (Quality of Life in Epilepsy-89 inventory) and temporary improvement in the Profile of Mood States. An adequately powered randomized controlled trial is needed to confirm our findings, which suggest that behavioral approaches may hold promise for motivated patients with epilepsy. Copyright © 2011 Elsevier Inc. All rights reserved.

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

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Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Effects of manipulating eating frequency during a behavioral weight loss intervention: a pilot randomized controlled trial.

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Bachman, Jessica L; Raynor, Hollie A

2012-05-01

Eating frequency has been inversely related to BMI but the impact of eating frequency on weight loss is unclear. This randomized controlled trial pilot study examined the effect of eating frequency on hunger, energy intake, and weight loss during a 6-month behavioral weight loss intervention. Participants (age: 51.0 ± 9.9 years, BMI: 35.5 ± 4.8 kg/m(2), 57.8% female, 94.1% white) were randomized to one of two eating frequency prescriptions: Three meal (n = 25): three eating bouts/day; or grazing (n = 26): eat at least 100 kcals every 2-3 h. Both groups attended 20 sessions and had identical dietary (1,200-1,500 kcals/day, frequency than three meal at 6 months (5.8 ± 1.1 eating bouts/day vs. 3.2 ± 0.6 eating bouts/day, P weight loss intervention.

Neighborhood Effects in a Behavioral Randomized Controlled Trial

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Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

2014-01-01

Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol

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Jin Yan

2017-04-01

Full Text Available Abstract Background Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM. Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. Methods This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs, personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers’ development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject’s participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis

Early Behavioral Intervention Is Associated with Normalized Brain Activity in Young Children with Autism

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Dawson, Geraldine; Jones, Emily J. H.; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J.; Webb, Sara J.

2012-01-01

Objective: A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Method:…

Babies Living Safe & Smokefree: randomized controlled trial of a multilevel multimodal behavioral intervention to reduce low-income children’s tobacco smoke exposure

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Bradley N. Collins

2017-03-01

Full Text Available Abstract Background Addressing children’s tobacco smoke exposure (TSE remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC, combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations. Methods/Design This trial uses a randomized two-group design with three measurement points: baseline, 3-month and 12-month follow-up. The primary outcome is bioverified child TSE; the secondary outcome is bioverified maternal quit status. Smoking mothers of children less than 6 years old are recruited from WIC clinics. All participants receive WIC system-level intervention based on the “Ask, Advise, Refer (AAR” best practices guidelines for pediatrics clinics. It includes training all WIC staff about the importance of maternal tobacco control; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE, advise about TSE harms and benefits of protection, and refer smokers to cessation services. After receiving the system intervention, mothers are randomized to receive 3 months of additional treatment or an attention control intervention: (1 The multimodal behavioral intervention (MBI treatment includes telephone counseling sessions about child TSE reduction and smoking cessation, provision of nicotine replacement therapy, a mobile app to support cessation efforts, and multimedia text messages about TSE and smoking cessation; (2 The attention control intervention offers equivalent contact as the MBI and includes nutrition

Evaluation of Two Interventions to Reduce Aggressive and Antisocial Behavior in First and Second Graders in a Resource-Poor Setting

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Klevens, Joanne; Martinez, Jose William; Le, Brenda; Rojas, Carlos; Duque, Adriana; Tovar, Rafael

2009-01-01

We conducted a three-arm cluster randomized controlled trial (n = 2491) to evaluate a teacher delivered intervention to reduce aggressive and antisocial behavior and increase prosocial behavior in the classroom. A second aim of this trial was to establish whether combining this intervention with an intervention for parents was better than the…

Behavioral Interventions for Anger, Irritability, and Aggression in Children and Adolescents.

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Sukhodolsky, Denis G; Smith, Stephanie D; McCauley, Spencer A; Ibrahim, Karim; Piasecka, Justyna B

2016-02-01

Anger, irritability, and aggression are among the most common reasons for child mental health referrals. This review is focused on two forms of behavioral interventions for these behavioral problems: Parent management training (PMT) and cognitive-behavioral therapy (CBT). First, we provide an overview of anger/irritability and aggression as the treatment targets of behavioral interventions, followed by a discussion of the general principles and techniques of these treatment modalities. Then we discuss our current work concerning the transdiagnostic approach to CBT for anger, irritability, and aggression. PMT is aimed at improving aversive patterns of family interactions that engender children's disruptive behavior. CBT targets deficits in emotion regulation and social problem-solving that are associated with aggressive behavior. Both forms of treatment have received extensive support in randomized controlled trials. Given that anger/irritability and aggressive behavior are common in children with a variety of psychiatric diagnoses, a transdiagnostic approach to CBT for anger and aggression is described in detail. PMT and CBT have been well studied in randomized controlled trials in children with disruptive behavior disorders, and studies of transdiagnostic approaches to CBT for anger and aggression are currently underway. More work is needed to develop treatments for other types of aggressive behavior (e.g., relational aggression) that have been relatively neglected in clinical research. The role of callous-unemotional traits in response to behavioral interventions and treatment of irritability in children with anxiety and mood disorders also warrants further investigation.

Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH: A randomized controlled trial study protocol

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Tsai Midi

2011-06-01

Full Text Available Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33% do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention or control (no change. At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI and standardized body mass index (zBMI. Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous, Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight

Effectiveness of a theory-based mobile phone text message intervention for improving protective behaviors of pregnant women against air pollution: a randomized controlled trial.

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Jasemzadeh, Mehrnoosh; Khafaie, Morteza Abdullatif; Jaafarzadeh, Nematallah; Araban, Marzieh

2018-03-01

Health impact of exposure to air pollution is a public health concern. The aim of this study was to investigate an extended parallel process model (EPPM)-based mobile phone text message intervention for improving protective behaviors against air pollution among pregnant women. In this randomized controlled trial (IRCT2016102810804N8), 130 pregnant women were randomly assigned into either experimental or control groups. A valid and reliable questionnaire was used to collect data. Experimental group received mobile phone intervention on a daily basis for 2 months. Control group received usual care, only. Data were analyzed using SPSS 15 applying t test, chi-square, and Wilcoxon and Mann-Whitney U test. Although before intervention, there were no significant differences between different structures of EPPM (P > 0.05), after intervention, there were statistically significant differences between perceived severity, response efficacy, self-efficacy, and protective behaviors between two groups (P mobile phone intervention could promote protective behaviors against air pollution among pregnant women. The present study might be used as a framework for evidence-based health promotion regarding air pollution risk communication and self-care behaviors. IRCT2016102810804N8.

Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes.

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Lynch, Cheryl P; Williams, Joni S; J Ruggiero, Kenneth; G Knapp, Rebecca; Egede, Leonard E

2016-03-22

Multiple randomized controlled trials (RCTs) show that behavioral lifestyle interventions are effective in improving diabetes management and that comprehensive risk factor management improves cardiovascular disease (CVD) outcomes. The role of technology has been gaining strong support as evidence builds of its potential to improve diabetes management; however, evaluation of its impact in minority populations is limited. This study intends to provide early evidence of a theory-driven intervention, Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS), using real-time videoconferencing for education and skills training. We examine the potential for TABLETS to improve health risk behaviors and reduce CVD risk outcomes among a low-income African American (AA) population with poorly controlled type 2 diabetes. The study is a two-arm, pilot controlled trial that randomizes 30 participants to the TABLETS intervention and 30 participants to a usual care group. Blinded outcome assessments will be completed at baseline, 2.5 months (immediate post-intervention), and 6.5 months (follow-up). The TABLETS intervention consists of culturally tailored telephone-delivered diabetes education and skills training delivered via videoconferencing on tablet devices, with two booster sessions delivered via tablet-based videoconferencing at 3 months and 5 months to stimulate ongoing use of the tablet device with access to intervention materials via videoconferencing slides and a manual of supplementary materials. The primary outcomes are physical activity, diet, medication adherence, and self-monitoring behavior, whereas the secondary outcomes are HbA1c, low-density lipoprotein cholesterol (LDL-C), BP, CVD risk, and quality of life. This study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven, tablet-aided behavioral intervention that utilizes real-time videoconferencing technology for education and skills training on self

Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

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Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

2016-03-01

Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

Applied Behavior Analysis: Beyond Discrete Trial Teaching

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Steege, Mark W.; Mace, F. Charles; Perry, Lora; Longenecker, Harold

2007-01-01

We discuss the problem of autism-specific special education programs representing themselves as Applied Behavior Analysis (ABA) programs when the only ABA intervention employed is Discrete Trial Teaching (DTT), and often for limited portions of the school day. Although DTT has many advantages to recommend its use, it is not well suited to teach…

Mechanisms of Behavioral and Affective Treatment Outcomes in a Cognitive Behavioral Intervention for Boys.

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Burke, Jeffrey D; Loeber, Rolf

2016-01-01

Evidence for effective treatment for behavioral problems continues to grow, yet evidence about the effective mechanisms underlying those interventions has lagged behind. The Stop Now and Plan (SNAP) program is a multicomponent intervention for boys between 6 and 11. This study tested putative treatment mechanisms using data from 252 boys in a randomized controlled trial of SNAP versus treatment as usual. SNAP includes a 3 month group treatment period followed by individualized intervention, which persisted through the 15 month study period. Measures were administered in four waves: at baseline and at 3, 9 and 15 months after baseline. A hierarchical linear modeling strategy was used. SNAP was associated with improved problem-solving skills, prosocial behavior, emotion regulation skills, and reduced parental stress. Prosocial behavior, emotion regulation skills and reduced parental stress partially mediated improvements in child aggression. Improved emotion regulation skills partially mediated treatment-related child anxious-depressed outcomes. Improvements in parenting behaviors did not differ between treatment conditions. The results suggest that independent processes may drive affective and behavioral outcomes, with some specificity regarding the mechanisms related to differing treatment outcomes.

Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model.

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Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer

2010-01-01

To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD: 15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism.

A randomized trial of a lifestyle intervention in obese endometrial cancer survivors: quality of life outcomes and mediators of behavior change

Directory of Open Access Journals (Sweden)

Kavanagh Mary

2009-02-01

Full Text Available Abstract Background To examine the effects of a 6 month lifestyle intervention on quality of life, depression, self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors. Methods Early stage endometrial cancer survivors were randomized to intervention (n = 23 or usual care (n = 22 groups. Chi-square, Student's t-test and repeated measures analysis of variance were used in intent-to-treat analyses. Outcomes were also examined according to weight loss. Results Morbidly obese patients had significantly lower self-efficacy, specifically when feeling physical discomfort. There was a significant improvement for self-efficacy related to social pressure (p = .03 and restraint (p = .02 in the LI group. There was a significant difference for emotional well-being quality of life (p = .02, self-efficacy related to negative emotions (p Conclusion This pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors. Trial Registration http://www.clinicaltrials.gov; NCT00420979

A Meta-Analysis of the Efficacy of Behavioral Interventions to Reduce Risky Sexual Behavior and Decrease Sexually Transmitted Infections in Latinas Living in the United States.

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Althoff, Meghan D; Grayson, Cary T; Witt, Lucy; Holden, Julie; Reid, Daniel; Kissinger, Patricia

2015-12-01

The objective of this meta-analysis was to determine the effect of behavioral interventions in reducing risky sexual behavior and incident sexually transmitted infections (STI) among Latina women living in the United States. Studies were found by systematically searching the MEDLINE, EMBASE, and PsychInfo databases without language restriction. Two independent reviewers screened abstracts and full texts of articles to find randomized control trials testing the effects of behavioral interventions aimed at changing risky sexual behavior among Latinas. Articles were selected using prespecified inclusion criteria. Two independent reviewers extracted data from the included trials in duplicate using a standardized data extraction form. Six randomized control trials met the inclusion criteria for a total of 2,909 participants. Using random effects models with inverse variance weighting, we found a protective effect of the behavioral intervention on reported risky sexual behavior (odds ratio = 0.52; 95% confidence interval = 0.42, 0.64) and on incident nonviral STI (odds ratio = 0.65; 95% confidence interval = 0.46, 0.93). Behavioral interventions targeted toward Latina populations are effective in reducing risky sexual behaviors and incident STI and should be considered by policymakers as a potential tool for HIV/STI prevention in this population. © 2014 Society for Public Health Education.

Electronic behavioral interventions for headache: a systematic review.

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Minen, Mia Tova; Torous, John; Raynowska, Jenelle; Piazza, Allison; Grudzen, Corita; Powers, Scott; Lipton, Richard; Sevick, Mary Ann

2016-01-01

There is increasing interest in using electronic behavioral interventions as well as mobile technologies such as smartphones for improving the care of chronic disabling diseases such as migraines. However, less is known about the current clinical evidence for the feasibility and effectiveness of such behavioral interventions. To review the published literature of behavioral interventions for primary headache disorders delivered by electronic means suitable for use outside of the clinician's office. An electronic database search of PubMed, PsycINFO, and Embase was conducted through December 11, 2015. All eligible studies were systematically reviewed to examine the modality in which treatment was delivered (computer, smartphone, watch and other), types of behavioral intervention delivered (cognitive behavioral therapy [CBT], biofeedback, relaxation, other), the headache type being treated, duration of treatment, adherence, and outcomes obtained by the trials to examine the overall feasibility of electronic behavioral interventions for headache. Our search produced 291 results from which 23 eligible articles were identified. Fourteen studies used the internet via the computer, 2 used Personal Digital Assistants, 2 used CD ROM and 5 used other types of devices. None used smartphones or wearable devices. Four were pilot studies (N ≤ 10) which assessed feasibility. For the behavioral intervention, CBT was used in 11 (48 %) of the studies, relaxation was used in 8 (35 %) of the studies, and biofeedback was used in 5 (22 %) of the studies. The majority of studies (14/23, 61 %) used more than one type of behavioral modality. The duration of therapy ranged from 4-8 weeks for CBT with a mean of 5.9 weeks. The duration of other behavioral interventions ranged from 4 days to 60 months. Outcomes measured varied widely across the individual studies. Despite the move toward individualized medicine and mHealth, the current literature shows that most studies using

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

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Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

2014-12-01

To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

A nudge toward participation: Improving clinical trial enrollment with behavioral economics.

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VanEpps, Eric M; Volpp, Kevin G; Halpern, Scott D

2016-07-20

Interventions informed by behavioral economics can address barriers to patient enrollment in clinical trials and improve recruitment efforts. Copyright © 2016, American Association for the Advancement of Science.

The Effect of Changes in Physical Activity on Sedentary Behavior: Results From a Randomized Lifestyle Intervention Trial.

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Siddique, Juned; de Chavez, Peter John; Craft, Lynette L; Freedson, Patty; Spring, Bonnie

2017-07-01

To investigate whether changes in physical activity (PA) have an impact on sedentary behavior (SB) during a lifestyle intervention. Study design was a randomized trial. Participants (n = 204) were individuals with low PA and high sedentary leisure screen time from the Chicago area. Participants were randomized to either increase PA (iPA) or decrease sedentary leisure (dSED). The intervention consisted of decision support, coaching, and financial incentives. For iPA participants, the goal was at least 60 min/d of self-reported moderate-tovigorous-intensity PA (MVPA). For dSED participants the goal was less than 90 min/d of sedentary leisure screen time. Daily accelerometer-based measures of SB and bout-corrected MVPA were obtained. Linear mixed-effects models were fit to estimate the effect of the intervention on MVPA and total SB and to estimate the effect of daily changes in MVPA on daily SB. The iPA participants increased their bout-corrected MVPA by 14 min/d (p much of this time by reducing their SB.

Effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes in survivors of colorectal cancer: a randomized controlled trial.

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Hawkes, Anna L; Chambers, Suzanne K; Pakenham, Kenneth I; Patrao, Tania A; Baade, Peter D; Lynch, Brigid M; Aitken, Joanne F; Meng, Xingqiong; Courneya, Kerry S

2013-06-20

Colorectal cancer survivors are at risk for poor health outcomes because of unhealthy lifestyles, but few studies have developed translatable health behavior change interventions. This study aimed to determine the effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes among colorectal cancer survivors. In this two-group randomized controlled trial, 410 colorectal cancer survivors were randomly assigned to the health coaching intervention (11 theory-based telephone-delivered health coaching sessions delivered over 6 months focusing on physical activity, weight management, dietary habits, alcohol, and smoking) or usual care. Assessment of primary (ie, physical activity [Godin Leisure Time Index], health-related quality of life [HRQoL; Short Form-36], and cancer-related fatigue [Functional Assessment of Chronic Illness Therapy Fatigue Scale]) and secondary outcomes (ie, body mass index [kg/m(2)], diet and alcohol intake [Food Frequency Questionnaire], and smoking) were conducted at baseline and 6 and 12 months. At 12 months, significant intervention effects were observed for moderate physical activity (28.5 minutes; P = .003), body mass index (-0.9 kg/m(2); P = .001), energy from total fat (-7.0%; P = .006), and energy from saturated fat (-2.8%; P = .016). A significant intervention effect was reported for vegetable intake (0.4 servings per day; P = .001) at 6 months. No significant group differences were found at 6 or 12 months for HRQoL, cancer-related fatigue, fruit, fiber, or alcohol intake, or smoking. The CanChange intervention was effective for improving physical activity, dietary habits, and body mass index in colorectal cancer survivors. The intervention is translatable through existing telephone cancer support and information services in Australia and other countries.

Using an Analysis of Behavior Change to Inform Effective Digital Intervention Design: How Did the PRIMIT Website Change Hand Hygiene Behavior Across 8993 Users?

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Ainsworth, B; Steele, M; Stuart, B; Joseph, J; Miller, S; Morrison, L; Little, P; Yardley, L

2017-06-01

In designing digital interventions for healthcare, it is important to understand not just whether interventions work but also how and for whom-including whether individual intervention components have different effects, whether a certain usage threshold is required to change behavior in each intervention and whether usage differs across population subgroups. We investigated these questions using data from a large trial of the digital PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory tract infection Transmission) (PRIMIT) intervention, which aimed to reduce respiratory tract infections (RTIs) by increasing hand hygiene behavior. Baseline and follow-up questionnaires measured behaviors, intentions and attitudes in hand hygiene. In conjunction with objective measures of usage of the four PRIMIT sessions, we analysed these observational data to examine mechanisms of behavior change in 8993 intervention users. We found that the PRIMIT intervention changed behavior, intentions and attitudes, and this change was associated with reduced RTIs. The largest hand hygiene change occurred after the first session, with incrementally smaller changes after each subsequent session, suggesting that engagement with the core behavior change techniques included in the first session was necessary and sufficient for behavior change. The intervention was equally effective for men and women, older and younger people and was particularly effective for those with lower levels of education. Our well-powered analysis has implications for intervention development. We were able to determine a 'minimum threshold' of intervention engagement that is required for hand hygiene change, and we discuss the potential implications this (and other analyses of this type) may have for further intervention development. We also discuss the application of similar analyses to other interventions.

A Randomized Controlled Trial Examination of a Remote Parenting Intervention: Engagement and Effects on Parenting Behavior and Child Abuse Potential.

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Baggett, Kathleen; Davis, Betsy; Feil, Edward; Sheeber, Lisa; Landry, Susan; Leve, Craig; Johnson, Ursula

2017-11-01

Technology advances increasingly allow for access to remotely delivered interventions designed to promote early parenting practices that protect against child maltreatment. Among low-income families, at somewhat elevated risk for child maltreatment, there is some evidence that parents do engage in and benefit from remote-coaching interventions. However, little is known about the effectiveness of such programs to engage and benefit families at high risk for child maltreatment due to multiple stressors associated with poverty. To address this limitation, we examined engagement and outcomes among mothers at heightened risk for child abuse, who were enrolled in a randomized controlled, intent-to-treat trial of an Internet adaptation of an evidence-based infant parenting intervention. We found that engagement patterns were similar between higher and lower risk groups. Moreover, an intervention dose by condition effect was found for increased positive parent behavior and reduced child abuse potential.

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

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Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial

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Macready, Anna L; Fallaize, Rosalind; Butler, Laurie T; Ellis, Judi A; Kuznesof, Sharron; Frewer, Lynn J; Celis-Morales, Carlos; Livingstone, Katherine M; Araújo-Soares, Vera; Fischer, Arnout RH; Stewart-Knox, Barbara J; Mathers, John C

2018-01-01

Background To determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation interventions undergo continuous development, and most are not adapted for Web-based delivery. The Food4Me study (N=1607) provided the opportunity to use existing frameworks to describe standardized Web-based techniques employed in a large-scale, internet-based intervention to change dietary behavior and physical activity. Objective The aims of this study were (1) to describe techniques embedded in the Food4Me study design and explain the selection rationale and (2) to demonstrate the use of behavior change technique taxonomies, develop standard operating procedures for training, and identify strengths and limitations of the Food4Me framework that will inform its use in future studies. Methods The 6-month randomized controlled trial took place simultaneously in seven European countries, with participants receiving one of four levels of personalized advice (generalized, intake-based, intake+phenotype–based, and intake+phenotype+gene–based). A three-phase approach was taken: (1) existing taxonomies were reviewed and techniques were identified a priori for possible inclusion in the Food4Me study, (2) a standard operating procedure was developed to maintain consistency in the use of methods and techniques across research centers, and (3) the Food4Me behavior change technique framework was reviewed and updated post intervention. An analysis of excluded techniques was also conducted. Results Of 46 techniques identified a priori as being applicable to Food4Me, 17 were embedded in the intervention design; 11 were from a dietary taxonomy, and 6 from a smoking cessation taxonomy. In addition, the four-category smoking cessation framework structure was adopted for clarity of

Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

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Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

2015-12-01

The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools

Verbal Bullying Changes among Students Following an Educational Intervention Using the Integrated Model for Behavior Change

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Naidoo, Saloshni; Satorius, Benn K.; de Vries, Hein; Taylor, Myra

2016-01-01

Background: Bullying behavior in schools can lead to psychosocial problems. School-based interventions are important in raising student awareness, developing their skills and in planning to reduce bullying behavior. Methods: A randomized controlled trial, using a school-based educational intervention to reduce verbal bullying, was conducted among…

Behavior therapy for children with Tourette disorder: a randomized controlled trial.

Science.gov (United States)

Piacentini, John; Woods, Douglas W; Scahill, Lawrence; Wilhelm, Sabine; Peterson, Alan L; Chang, Susanna; Ginsburg, Golda S; Deckersbach, Thilo; Dziura, James; Levi-Pearl, Sue; Walkup, John T

2010-05-19

Tourette disorder is a chronic and typically impairing childhood-onset neurologic condition. Antipsychotic medications, the first-line treatments for moderate to severe tics, are often associated with adverse effects. Behavioral interventions, although promising, have not been evaluated in large-scale controlled trials. To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents. Randomized, observer-blind, controlled trial of 126 children recruited from December 2004 through May 2007 and aged 9 through 17 years, with impairing Tourette or chronic tic disorder as a primary diagnosis, randomly assigned to 8 sessions during 10 weeks of behavior therapy (n = 61) or a control treatment consisting of supportive therapy and education (n = 65). Responders received 3 monthly booster treatment sessions and were reassessed at 3 and 6 months following treatment. Comprehensive behavioral intervention. Yale Global Tic Severity Scale (range 0-50, score >15 indicating clinically significant tics) and Clinical Global Impressions-Improvement Scale (range 1 [very much improved] to 8 [very much worse]). Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale (24.7 [95% confidence interval {CI}, 23.1-26.3] to 17.1 [95% CI, 15.1-19.1]) from baseline to end point compared with the control treatment (24.6 [95% CI, 23.2-26.0] to 21.1 [95% CI, 19.2-23.0]) (P tic worsening was reported by 4% of children (5/126). Treatment gains were durable, with 87% of available responders to behavior therapy exhibiting continued benefit 6 months following treatment. A comprehensive behavioral intervention, compared with supportive therapy and education, resulted in greater improvement in symptom severity among children with Tourette and chronic tic disorder. clinicaltrials.gov Identifier: NCT00218777.

A Randomized Controlled Trial on the Efficacy of a Psychosocial Behavioral Intervention to Improve the Lifestyle of Patients With Severe Mental Disorders: Study Protocol

Directory of Open Access Journals (Sweden)

Gaia Sampogna

2018-06-01

Full Text Available Patients with severe mental disorders die on average 20 years prior to the general population. This mortality gap is mainly due to the higher prevalence of physical diseases and the adoption of unhealthy lifestyle behaviors.The LIFESTYLE trial aims to evaluate the efficacy of a new psychosocial group intervention (including psychoeducational, motivational, and problem-solving techniques focused on healthy lifestyle behavior compared to a brief educational group intervention in a community sample of patients with severe mental disorders. The trial is a national-funded, multicentric, randomized controlled trial with blinded outcome assessments, which is carried out in six outpatient units of the Universities of Campania “Luigi Vanvitelli” in Naples, Bari, Genova, L'Aquila, Pisa, and Rome—Tor Vergata. All patients are assessed at the following time points: baseline (T0; 2 months post-randomization (T1; 4 months post-randomization (T2; 6 months post-randomization (T3; 12 months post-randomization (T4; and 24 months post-randomization (T5. T1 and T2 assessments include only anthropometric tests. The BMI, a reliable and feasible anthropometric parameter, has been selected as primary outcome. In particular, the mean value of BMI at 6 months from baseline (T3 will be evaluated through a Generalized Estimated Equation model. The work hypothesis is that the LIFESTYLE psychosocial group intervention will be more effective than the brief educational group intervention in reducing the BMI. We expect a mean difference between the two groups of at least one point (and standard deviation of two points at BMI. Secondary outcomes are: the improvement in dietary patterns, in smoking habits, in sleeping habits, physical activity, personal and social functioning, severity of physical comorbidities, and adherence to medications. The expected sample size consists of 420 patients (70 patients for each of the six participating centers, and they are allocated with

Collaborative care intervention targeting violence risk behaviors, substance use, and posttraumatic stress and depressive symptoms in injured adolescents: a randomized clinical trial.

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Zatzick, Douglas; Russo, Joan; Lord, Sarah Peregrine; Varley, Christopher; Wang, Jin; Berliner, Lucy; Jurkovich, Gregory; Whiteside, Lauren K; O'Connor, Stephen; Rivara, Frederick P

2014-06-01

Violence and injury risk behaviors, alcohol and drug use problems, and posttraumatic stress disorder (PTSD) and depressive symptoms occur frequently among adolescents presenting to acute care medical settings after traumatic physical injury. To test the effectiveness of a stepped collaborative care intervention targeting this constellation of risk behaviors and symptoms in randomly sampled hospitalized adolescents with and without traumatic brain injury. A pragmatic randomized clinical trial was conducted at a single US level I trauma center. Participants included 120 adolescents aged 12 to 18 years randomized to intervention (n = 59) and control (n = 61) conditions. Stepped collaborative care intervention included motivational interviewing elements targeting risk behaviors and substance use as well as medication and cognitive behavioral therapy elements targeting PTSD and depressive symptoms. Adolescents were assessed at baseline before randomization and 2, 5, and 12 months after injury hospitalization. Standardized instruments were used to assess violence risk behaviors, alcohol and drug use, and PTSD and depressive symptoms. The investigation attained more than 95% adolescent follow-up at each assessment point. At baseline, approximately one-third of the participants endorsed the violence risk behavior of carrying a weapon. Regression analyses demonstrated that intervention patients experienced significant reductions in weapon carrying compared with controls during the year after injury (group × time effect, F3,344 = 3.0; P = .03). At 12 months after the injury, 4 (7.3%) intervention patients vs 13 (21.3%) control patients reported currently carrying a weapon (relative risk, 0.31; 95% CI, 0.11-0.90). The intervention was equally effective in reducing the risk of weapon carrying among injured adolescents with and without traumatic brain injury. Other treatment targets, including alcohol and drug use problems and high levels of PTSD and

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

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Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-06-01

The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

Assessing and comparing the short-term effects of TPB only and TPB plus implementation intentions interventions on snacking behavior in Iranian adolescent girls: a cluster randomized trial.

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Karimi-Shahanjarini, Akram; Rashidian, Arash; Omidvar, Nasrin; Majdzadeh, Reza

2013-01-01

The evidence for the effectiveness of theory of planned behavior (TPB)-based interventions is mixed. There is also mixed evidence on the effectiveness of adding implementation intentions to TPB-based interventions. In this study we assessed and compared the short-term effects of TPB-only intervention and TPB plus implementation intentions intervention on snacking behavior and intention to consume unhealthy snacks in Iranian adolescent girls. Three-arm cluster randomized controlled trial. Ten middle schools in Tehran (Iran). A total of 29 classes included 739 female adolescents (age range: 12-15 years). Intervention. Two brief interventions including TPB-only intervention and TPB plus implementation intentions intervention. Food frequency questionnaire and intentions at baseline, 10 days, and 3 months measuring snacking behavior and cognitions about unhealthy snack consumption, respectively. Hierarchical linear modeling to assess the interventions' effects. Both interventions successfully decreased intention to consume and consumption of unhealthy snacks at postintervention. Calculation of the effect sizes revealed that the TPB plus implementation intentions intervention was more effective than the TPB-only intervention. The effects remained significant at 3-month follow-up in the TPB plus implementation intentions intervention group only, although the effect size decreased. Overall, the study suggests that adding implementation intentions on top of TPB-based persuasive messages improves effectiveness and sustainability of desirable changes.

Behavioral Nutrition Interventions Using e- and m-Health Communication Technologies: A Narrative Review.

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Olson, Christine M

2016-07-17

e- and m-Health communication technologies are now common approaches to improving population health. The efficacy of behavioral nutrition interventions using e-health technologies to decrease fat intake and increase fruit and vegetable intake was demonstrated in studies conducted from 2005 to 2009, with approximately 75% of trials showing positive effects. By 2010, an increasing number of behavioral nutrition interventions were focusing on body weight. The early emphasis on interventions that were highly computer tailored shifted to personalized electronic interventions that included weight and behavioral self-monitoring as key features. More diverse target audiences began to participate, and mobile components were added to interventions. Little progress has been made on using objective measures rather than self-reported measures of dietary behavior. A challenge for nutritionists is to link with the private sector in the design, use, and evaluation of the many electronic devices that are now available in the marketplace for nutrition monitoring and behavioral change.

Dietary patterns in obese pregnant women; influence of a behavioral intervention of diet and physical activity in the UPBEAT randomized controlled trial.

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Flynn, Angela C; Seed, Paul T; Patel, Nashita; Barr, Suzanne; Bell, Ruth; Briley, Annette L; Godfrey, Keith M; Nelson, Scott M; Oteng-Ntim, Eugene; Robinson, Sian M; Sanders, Thomas A; Sattar, Naveed; Wardle, Jane; Poston, Lucilla; Goff, Louise M

2016-11-29

Understanding dietary patterns in obese pregnant women will inform future intervention strategies to improve pregnancy outcomes and the health of the child. The aim of this study was to investigate the effect of a behavioral intervention of diet and physical activity advice on dietary patterns in obese pregnant woman participating in the UPBEAT study, and to explore associations of dietary patterns with pregnancy outcomes. In the UPBEAT randomized controlled trial, pregnant obese women from eight UK multi-ethnic, inner-city populations were randomly assigned to receive a diet/physical activity intervention or standard antenatal care. The dietary intervention aimed to reduce glycemic load and saturated fat intake. Diet was assessed using a food frequency questionnaire (FFQ) at baseline (15 +0 -18 +6 weeks' gestation), post intervention (27 +0 -28 +6 weeks) and in late pregnancy (34 +0 -36 +0 weeks). Dietary patterns were characterized using factor analysis of the baseline FFQ data, and changes compared in the control and intervention arms. Patterns were related to pregnancy outcomes in the combined control/intervention cohort (n = 1023). Four distinct baseline dietary patterns were defined; Fruit and vegetables, African/Caribbean, Processed, and Snacks, which were differently associated with social and demographic factors. The UPBEAT intervention significantly reduced the Processed (-0.14; 95% CI -0.19, -0.08, P obese pregnant women an intensive dietary intervention improved Processed and Snack dietary pattern scores. African/Caribbean and Processed patterns were associated with an increased risk of gestational diabetes, and provide potential targets for future interventions. Current controlled trials; ISRCTN89971375.

The use and utility of specific nonpharmacological interventions for behavioral symptoms in dementia: an exploratory study.

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Cohen-Mansfield, Jiska; Marx, Marcia S; Dakheel-Ali, Maha; Thein, Khin

2015-02-01

This study compares different nonpharmacological interventions for persons with behavioral symptoms and dementia on frequency of use and perceived efficacy in terms of change in behavior and interest. Participants were 89 nursing home residents from six Maryland nursing homes with a mean age of 85.9 years (SD: 8.6 years). Research assistants presented interventions tailored to the participants' needs and preferences in a pre-intervention trial phase and in an intervention phase. The impact of each intervention on behavioral symptoms and on the person's interest was rated immediately after the intervention by a research assistant. The most utilized interventions in both trial and treatment phases were the social intervention of one-on-one interaction, simulated social interventions such as a lifelike doll and respite video, the theme intervention of magazine, and the sensory stimulation intervention of music. In contrast, the least utilized interventions in both phases were sewing, fabric book, and flower arrangement. Interventions with the highest impact on behavioral symptoms included one-on-one social interaction, hand massage, music, video, care, and folding towels. Other high impact interventions included walking, going outside, flower arranging, food or drink, sewing, group activity, book presentation, ball toss, coloring or painting, walking, and family video. The results provide initial directions for choosing specific interventions for persons with dementia and also demonstrate a methodology for increasing knowledge through ongoing monitoring of practice. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

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Aleksandra E. Zgierska

2017-01-01

Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial.

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Koniak-Griffin, Deborah; Brecht, Mary-Lynn; Takayanagi, Sumiko; Villegas, Juan; Melendrez, Marylee; Balcázar, Héctor

2015-01-01

Low-income Latinas (Hispanics) face risk for cardiovascular disease due to high rates of overweight/obesity, sedentary lifestyle, and other factors. Limited access to health care and language barriers may prevent delivery of health promotion messages. Targeted approaches, including the integration of community health workers, may be required to promote healthy lifestyle and prevent chronic disease in underserved ethnic minority groups. The term commonly used to refer to female community health workers in Latino communities is "promotora(s)." This study evaluates the outcomes and feasibility of a promotora-led lifestyle behavior intervention for overweight, immigrant Latinas. A community prevention model was employed in planning and implementing this study. A randomized controlled trial design was used. A Community Advisory Board provided expertise in evaluating feasibility of study implementation in the community and other important guidance. The sample was comprised of 223 women aged 35-64 years, predominantly with low income and ≤8th grade education. The culturally tailored Lifestyle Behavior Intervention included group education (8 classes based upon Su Corazon, Su Vida), followed by 4 months of individual teaching and coaching (home visits and telephone calls). The control group received a comparable length educational program and follow-up contacts. Evaluations were conducted at baseline and at 6 and 9 months using a dietary habits questionnaire, accelerometer readings of physical activity, and clinical measures (body mass index, weight, waist circumference, blood pressure, lipids, blood glucose). Data were collected between January 2010 and August 2012. Women in the intervention group improved significantly in dietary habits, waist circumference, and physical activity in comparison to those in the control group. A treatment dosage effect was observed for weight and waist circumference. Knowledge about heart disease increased. High attendance at classes and

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

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Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol.

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Yan, Jin; Zhang, Aidi; Zhou, Liang; Huang, Zhulin; Zhang, Pan; Yang, Guoli

2017-04-24

Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM). Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app) aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs), personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers' development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject's participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis. This will be the first study of its kind in China to

Internet-Assisted Parent Training Intervention for Disruptive Behavior in 4-Year-Old Children: A Randomized Clinical Trial.

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Sourander, Andre; McGrath, Patrick J; Ristkari, Terja; Cunningham, Charles; Huttunen, Jukka; Lingley-Pottie, Patricia; Hinkka-Yli-Salomäki, Susanna; Kinnunen, Malin; Vuorio, Jenni; Sinokki, Atte; Fossum, Sturla; Unruh, Anita

2016-04-01

There is a large gap worldwide in the provision of evidence-based early treatment of children with disruptive behavioral problems. To determine whether an Internet-assisted intervention using whole-population screening that targets the most symptomatic 4-year-old children is effective at 6 and 12 months after the start of treatment. This 2-parallel-group randomized clinical trial was performed from October 1, 2011, through November 30, 2013, at a primary health care clinic in Southwest Finland. Data analysis was performed from August 6, 2015, to December 11, 2015. Of a screened population of 4656 children, 730 met the screening criteria indicating a high level of disruptive behavioral problems. A total of 464 parents of 4-year-old children were randomized into the Strongest Families Smart Website (SFSW) intervention group (n = 232) or an education control (EC) group (n = 232). The SFSW intervention, an 11-session Internet-assisted parent training program that included weekly telephone coaching. Child Behavior Checklist version for preschool children (CBCL/1.5-5) externalizing scale (primary outcome), other CBCL/1.5-5 scales and subscores, Parenting Scale, Inventory of Callous-Unemotional Traits, and the 21-item Depression, Anxiety, and Stress Scale. All data were analyzed by intention to treat and per protocol. The assessments were made before randomization and 6 and 12 months after randomization. Of the children randomized, 287 (61.9%) were male and 79 (17.1%) lived in other than a family with 2 biological parents. At 12-month follow-up, improvement in the SFSW intervention group was significantly greater compared with the control group on the following measures: CBCL/1.5-5 externalizing scale (effect size, 0.34; P anxiety (effect size, 0.26; P = .003), and emotional problems (effect size, 0.31; P = .001); Inventory of Callous-Unemotional Traits callousness scores (effect size, 0.19; P = .03); and self-reported parenting skills (effect size

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

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Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

OpenAIRE

Ono, Yutaka; Awata, Shuichi; Iida, Hideharu; Ishida, Yasushi; Ishizuka, Naoki; Iwasa, Hiroto; Kamei, Yuichi; Motohashi, Yutaka; Nakagawa, Atsuo; Nakamura, Jun; Nishi, Nobuyuki; Otsuka, Kotaro; Oyama, Hirofumi; Sakai, Akio; Sakai, Hironori

2008-01-01

Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP) have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention re...

A Behavioral Lifestyle Intervention Enhanced With Multiple-Behavior Self-Monitoring Using Mobile and Connected Tools for Underserved Individuals With Type 2 Diabetes and Comorbid Overweight or Obesity: Pilot Comparative Effectiveness Trial.

Science.gov (United States)

Wang, Jing; Cai, Chunyan; Padhye, Nikhil; Orlander, Philip; Zare, Mohammad

2018-04-10

Self-monitoring is a cornerstone of behavioral lifestyle interventions for obesity and type 2 diabetes mellitus. Mobile technology has the potential to improve adherence to self-monitoring and patient outcomes. However, no study has tested the use of a smartphone to facilitate self-monitoring in overweight or obese adults with type 2 diabetes mellitus living in the underserved community. The aim of this study was to examine the feasibility of and compare preliminary efficacy of a behavioral lifestyle intervention using smartphone- or paper-based self-monitoring of multiple behaviors on weight loss and glycemic control in a sample of overweight or obese adults with type 2 diabetes mellitus living in underserved communities. We conducted a randomized controlled trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention. Overweight or obese patients with type 2 diabetes mellitus were recruited from an underserved minority community health center in Houston, Texas. They were randomly assigned to one of the three groups: (1) behavior intervention with smartphone-based self-monitoring, (2) behavior intervention with paper diary-based self-monitoring, and (3) usual care group. Both the mobile and paper groups received a total of 11 face-to-face group sessions in a 6-month intervention. The mobile group received an Android-based smartphone with 2 apps loaded to help them record their diet, physical activity, weight, and blood glucose, along with a connected glucometer, whereas the paper group used paper diaries for these recordings. Primary outcomes of the study included percentage weight loss and glycated hemoglobin (HbA 1c ) changes over 6 months. A total of 26 patients were enrolled: 11 in the mobile group, 9 in the paper group, and 6 in the control group. We had 92% (24/26) retention rate at 6 months. The sample is predominantly African Americans with an average age of 56.4 years and body mass index of 38.1. Participants lost an

Web-Based Intervention for Nutritional Management in Cystic Fibrosis: Development, Usability, and Pilot Trial.

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Stark, Lori J; Opipari-Arrigan, Lisa; Filigno, Stephanie S; Simon, Stacey L; Leonard, Amanda; Mogayzel, Peter J; Rausch, Joseph; Zion, Cynthia; Powers, Scott W

2016-06-01

Usability and pilot testing of a web intervention (BeInCharge.org [BIC]) of behavior plus nutrition intervention for children with cystic fibrosis (CF) ages 4-9 years. Think Aloud methodology was used with five mothers to assess usability and refine the intervention. A pilot trial was then conducted with 10 mothers of children with CF ages 4-9 years randomized to the web-based BIC or a Standard Care Control (STC). Change in weight gain for each group was compared in a pre-to-post design. Mothers rated the usability and clarity of BIC highly. The pilot trial showed children of mothers who received BIC had a significant change in weight pre-to-post-treatment (0.67 kg, p = .04). Change for the STC was not significant (0.41 kg, p = .10). A web-based behavior plus nutrition intervention appears promising in increasing weight gain in children with CF. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

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Halbert, Chanita Hughes; Bellamy, Scarlett; Briggs, Vanessa; Delmoor, Ernestine; Purnell, Joseph; Rogers, Rodney; Weathers, Benita; Johnson, Jerry C.

2017-01-01

Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a…

PortionControl@HOME: Results of a Randomized Controlled Trial Evaluating the Effect of a Multi-Component Portion Size Intervention on Portion Control Behavior and Body Mass Index

NARCIS (Netherlands)

Poelman, M.P.; Vet, de E.; Velema, E.; Boer, de M.R.; Seidell, J.C.; Steenhuis, I.H.M.

2015-01-01

Background Food portion sizes influence energy intake. Purpose The purpose of this paper is to determine effectiveness of the “PortionControl@HOME” intervention on body mass index and portion control behavior. Methods A randomized controlled trial among 278 overweight and obese participants was

Interventions to improve hemodialysis adherence: a systematic review of randomized-controlled trials.

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Matteson, Michelle L; Russell, Cynthia

2010-10-01

Over 485,000 people in the United States have chronic kidney disease, a progressive kidney disease that may lead to hemodialysis. Hemodialysis involves a complex regimen of treatment, medication, fluid, and diet management. In 2005, over 312,000 patients were undergoing hemodialysis in the United States. Dialysis nonadherence rates range from 8.5% to 86%. Dialysis therapy treatment nonadherence, including treatment, medication, fluid, and diet nonadherence, significantly increases the risk of morbidity and mortality. The purpose of this paper is to systematically review randomized-controlled trial intervention studies designed to increase treatment, medication, fluid, and diet adherence in adult hemodialysis patients. A search of Cumulative Index of Nursing and Allied Health Literature (CINAHL) (1982 to May 2008), MEDLINE (1950 to May 2008), PsycINFO (1806 to May 2008), and all Evidence-Based Medicine (EBM) Reviews (Cochran DSR, ACP Journal Club, DARE, and CCTR) was conducted to identify randomized-controlled studies that tested the efficacy of interventions to improve adherence in adult hemodialysis patients. Eight randomized-controlled trials met criteria for inclusion. Six of the 8 studies found statistically significant improvement in adherence with the intervention. Of these 6 intervention studies, all studies had a cognitive component, with 3 studies utilizing cognitive/behavioral intervention strategies. Based on this systematic review, interventions utilizing a cognitive or cognitive/behavioral component appear to show the most promise for future study. © 2010 The Authors. Hemodialysis International © 2010 International Society for Hemodialysis.

Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

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Huisjes Anjoke JM

2007-07-01

Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

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Milette, Katherine; Roseman, Michelle; Thombs, Brett D

2011-03-01

The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation.

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Chacko, Anil; Isham, Andrew; Cleek, Andrew F; McKay, Mary M

2016-01-01

Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventions that focus on assisting parents to utilize effective skills to modify children's problematic behaviors are first-line interventions for the treatment of DBDs. Although efficacious, the effects of these interventions are often attenuated by poor implementation of the skills learned during treatment by parents, often referred to as between-session homework. The multiple family group (MFG) model is an evidence-based, skills-based intervention model for the treatment of DBDs in school-age youth residing in urban, socio-economically disadvantaged communities. While data suggest benefits of MFG on DBD behaviors, similar to other skill-based interventions, the effects of MFG are mitigated by the poor homework implementation, despite considerable efforts to support parents in homework implementation. This paper focuses on the study protocol for the development and preliminary evaluation of a theory-based, smartphone mobile health (mHealth) application (My MFG) to support homework implementation by parents participating in MFG. This paper describes a study design proposal that begins with a theoretical model, uses iterative design processes to develop My MFG to support homework implementation in MFG through a series of pilot studies, and a small-scale pilot randomised controlled trial to determine if the intervention can demonstrate change (preliminary efficacy) of My MFG in outpatient mental health settings in socioeconomically disadvantaged communities. This preliminary study aims to understand the implementation of mHealth methods to improve the effectiveness of evidence-based interventions in routine outpatient mental health care settings for youth with disruptive behavior and their families. Developing methods to augment the benefits of evidence

A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

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Nieuwsma, Jason A; Wray, Laura O; Voils, Corrine I; Gierisch, Jennifer M; Dundon, Margaret; Coffman, Cynthia J; Jackson, George L; Merwin, Rhonda; Vair, Christina; Juntilla, Karen; White-Clark, Courtney; Jeffreys, Amy S; Harris, Amy; Owings, Michael; Marr, Johnpatrick; Edelman, David

2017-09-01

Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. ClinicalTrials.gov identifier NCT01838226. Published by Elsevier Inc.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

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Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

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Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

2010-01-01

Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

A behavioral weight-loss intervention in persons with serious mental illness.

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Daumit, Gail L; Dickerson, Faith B; Wang, Nae-Yuh; Dalcin, Arlene; Jerome, Gerald J; Anderson, Cheryl A M; Young, Deborah R; Frick, Kevin D; Yu, Airong; Gennusa, Joseph V; Oefinger, Meghan; Crum, Rosa M; Charleston, Jeanne; Casagrande, Sarah S; Guallar, Eliseo; Goldberg, Richard W; Campbell, Leslie M; Appel, Lawrence J

2013-04-25

Overweight and obesity are epidemic among persons with serious mental illness, yet weight-loss trials systematically exclude this vulnerable population. Lifestyle interventions require adaptation in this group because psychiatric symptoms and cognitive impairment are highly prevalent. Our objective was to determine the effectiveness of an 18-month tailored behavioral weight-loss intervention in adults with serious mental illness. We recruited overweight or obese adults from 10 community psychiatric rehabilitation outpatient programs and randomly assigned them to an intervention or a control group. Participants in the intervention group received tailored group and individual weight-management sessions and group exercise sessions. Weight change was assessed at 6, 12, and 18 months. Of 291 participants who underwent randomization, 58.1% had schizophrenia or a schizoaffective disorder, 22.0% had bipolar disorder, and 12.0% had major depression. At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.3, and the mean weight was 102.7 kg (225.9 lb). Data on weight at 18 months were obtained from 279 participants. Weight loss in the intervention group increased progressively over the 18-month study period and differed significantly from the control group at each follow-up visit. At 18 months, the mean between-group difference in weight (change in intervention group minus change in control group) was -3.2 kg (-7.0 lb, P=0.002); 37.8% of the participants in the intervention group lost 5% or more of their initial weight, as compared with 22.7% of those in the control group (P=0.009). There were no significant between-group differences in adverse events. A behavioral weight-loss intervention significantly reduced weight over a period of 18 months in overweight and obese adults with serious mental illness. Given the epidemic of obesity and weight-related disease among persons with serious mental illness, our findings

Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial

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Alison Quinlan

2017-11-01

Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform

Using Trial-Based Functional Analysis to Design Effective Interventions for Students Diagnosed with Autism Spectrum Disorder

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Larkin, Wallace; Hawkins, Renee O.; Collins, Tai

2016-01-01

Functional behavior assessments and function-based interventions are effective methods for addressing the challenging behaviors of children; however, traditional functional analysis has limitations that impact usability in applied settings. Trial-based functional analysis addresses concerns relating to the length of time, level of expertise…

Effects of lifestyle intervention using patient-centered cognitive behavioral therapy among patients with cardio-metabolic syndrome: a randomized, controlled trial.

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Zhang, Ying; Mei, Songli; Yang, Rui; Chen, Ling; Gao, Hang; Li, Li

2016-11-18

Cardio-metabolic syndrome (CMS) is a highly prevalent condition. There is an urgent need to identify effective and integrated multi-disciplinary approaches that can reduce risk factors for CMS. Sixty-two patients with a history of CMS were randomized 1:1 into two groups: a standard information -only group (control), or a self-regulated lifestyle waist circumference (patient-centered cognitive behavioral therapy) intervention group. A pretest and posttest, controlled, experimental design was used. Outcomes were measured at the baseline (week 0) and at the end of intervention (week 12). Comparisons were drawn between groups and over time. The mean (standard deviation) age of the subjects was 48.6 (5.8) years ranging from 32 to 63, and 56.9% of the participants were female. Both groups showed no significant differences in Demographic variables and the metabolic syndrome indicators at baseline. While the control group only showed modest improvement after 12 weeks, compared to baseline, the intervention group demonstrated significant improvement from baseline. This study controlled for patients' demographics and baseline characteristics when assessing the effects of intervention. After adjusting for age, education and baseline level, the experimental group and the control group were statistically significant different in the following post-treatment outcomes: WC (F = 35.96, P cognitive behavioral therapy can improve the physical and mental health conditions among individuals reporting a history of cardio-metabolic syndrome, and possibly provided preliminary benefits for the treatment of CMS. Chinese Clinical Trial Register #, ChiCTR15006148 .

Blended Interventions to Change Behavior in Patients With Chronic Somatic Disorders: Systematic Review.

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Kloek, Corelien; Bossen, Daniël; de Bakker, Dinny H; Veenhof, Cindy; Dekker, Joost

2017-12-21

Blended behavior change interventions combine therapeutic guidance with online care. This new way of delivering health care is supposed to stimulate patients with chronic somatic disorders in taking an active role in their disease management. However, knowledge about the effectiveness of blended behavior change interventions and how they should be composed is scattered. This comprehensive systematic review aimed to provide an overview of characteristics and effectiveness of blended behavior change interventions for patients with chronic somatic disorders. We searched for randomized controlled trials published from 2000 to April 2017 in PubMed, Embase, CINAHL, and Cochrane Central Register of Controlled Trials. Risk of bias was assessed using the Cochrane Collaboration tool. Study characteristics, intervention characteristics, and outcome data were extracted. Studies were sorted based on their comparison group. A best-evidence synthesis was conducted to summarize the effectiveness. A total of 25 out of the 29 included studies were of high quality. Most studies (n=21; 72%) compared a blended intervention with no intervention. The majority of interventions focused on changing pain behavior (n=17; 59%), and the other interventions focused on lifestyle change (n=12; 41%). In addition, 26 studies (90%) focused on one type of behavior, whereas 3 studies (10%) focused on multiple behaviors. A total of 23 studies (79%) mentioned a theory as basis for the intervention. The therapeutic guidance in most studies (n=18; 62%) was non face-to-face by using email, phone, or videoconferencing, and in the other studies (partly), it was face-to-face (n=11; 38%). In 26 studies (90%), the online care was provided via a website, and in 3 studies (10%) via an app. In 22 studies (76%), the therapeutic guidance and online care were integrated instead of two separate aspects. A total of 26 outcome measures were included in the evidence synthesis comparing blended interventions with no

Optimization of behavioral, biobehavioral, and biomedical interventions the multiphase optimization strategy (MOST)

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Collins, Linda M

2018-01-01

This book presents a framework for development, optimization, and evaluation of behavioral,  biobehavioral, and biomedical interventions.  Behavioral, biobehavioral, and biomedical interventions are programs with the objective of improving and maintaining human health and well-being, broadly defined, in individuals, families, schools, organizations, or communities.  These interventions may be aimed at, for example, preventing or treating disease, promoting physical and mental health, preventing violence, or improving academic achievement.   This volume introduces the Multiphase Optimization Strategy (MOST), pioneered at The Methodology Center at the Pennsylvania State University, as an alternative to the classical approach of relying solely on the randomized controlled trial (RCT).  MOST borrows heavily from perspectives taken and approaches used in engineering, and also integrates concepts from statistics and behavioral science, including the RCT.  As described in detail in this book, MOST consists of ...

A Nutrition Education Intervention Trial for Adolescent Girls in Isfahan: Study Design and Protocol

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Morvarid Ghasab Shirazi

2016-11-01

Full Text Available BackgroundNutrition behaviors of adolescent girls is of serious health concerns. Although nutrition education interventions in Iran have met with some success, most of them could not promote nutrition behavioral changes. The aim of our study is to determine a school-based nutrition education intervention to improve adolescents’ nutrition behaviors and behavioral mediators based on the social cognitive theory (SCT.Materials and MethodsThis study is a single-blind randomized controlled trial. Eligible participants will be all student girls in grade 6 and 7, their parents and teachers in Isfahan governmental schools. This multi com­ponent school-based intervention include adolescents’ nutrition education package, parents’ nutrition massages, participatory homework, parents and teachers nutrition education package, supportive group, and collaboration with decision makers. Changing in nutrition behaviors including breakfast, fruit and vegetable, snack and fast food consumption will be examined, as primary outcome. Secondary outcome will be behavioral mediators such as knowledge, self-efficacy, intention, situation, self-regulation, social support, outcome expectations and expectancies, in adolescent girls. The outcomes will be assessed at baseline, and after 3 and 6-month follow-up.DiscussionThis study evaluates a school-based, guided SCT intervention, designed to improve healthy dietary behaviors, nutrition knowledge of adolescent girls. Few behavioral interventions have targeted this high-risk population in Iran. The intervention seems to be promising and has the potential to bridge the gap of the limited program outcomes of nutrition education in Iranian adolescents.

Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

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Lona Roll

2013-01-01

Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

A Systematic Review of Electronic Mindfulness-Based Therapeutic Interventions for Weight, Weight-Related Behaviors, and Psychological Stress.

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Lyzwinski, Lynnette Nathalie; Caffery, Liam; Bambling, Matthew; Edirippulige, Sisira

2018-03-01

Recent research indicates that mindfulness-based interventions are effective for stress, maladaptive weight-related behaviors, and weight loss. Little is presently known about their applicability and effectiveness when delivered electronically, including through Web-based and mobile device media. The primary aims of this review were to identify what types of electronic mindfulness-based interventions have been undertaken for stress, maladaptive weight-related behaviors, and weight loss, and to assess their overall effectiveness. A systematic search of PubMed (MEDLINE), Embase, CINAHL, and Web of Science databases was undertaken in June 2016. A total of 21 studies were identified that met inclusion criteria and were selected in the final review. Of these, 19 were mindfulness-based interventions for stress reduction. Two were Web-based mindful eating/intuitive eating interventions for weight. Only one electronic mindfulness-based study was identified that targeted both stress and maladaptive weight-related behaviors. Most electronic interventions were effective for stress reduction N = 14/19 (74%). There were insufficient electronic mindfulness-based interventions for weight to determine if they were effective or not. Additionally, no mobile mindfulness-based intervention was identified for weight or weight-related behaviors. Electronic mindfulness-based interventions through diverse media appear to be effective for stress reduction. More studies are needed that target weight and weight-related behaviors as well as studies that target both stress and weight. More randomized controlled trials (RCTs) that assess mobile mindfulness-based apps are needed as we only identified four app trials for stress. Mobile mindfulness-based interventions for weight and weight-related behaviors are a future area of research novelty.

Partner randomized controlled trial: study protocol and coaching intervention

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Garbutt Jane M

2012-04-01

Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

Randomized Controlled Trial of Nurse-Delivered Cognitive Behavioral Therapy Versus Supportive Psychotherapy Telehealth Interventions for Chronic Back Pain.

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Rutledge, Thomas; Atkinson, J Hampton; Holloway, Rachael; Chircop-Rollick, Tatiana; D'Andrea, John; Garfin, Steven R; Patel, Shetal; Penzien, Donald B; Wallace, Mark; Weickgenant, Anne L; Slater, Mark

2018-04-16

This study evaluated a nurse-delivered, telehealth intervention of cognitive behavioral therapy versus supportive psychotherapy for chronic back pain. Participants (N=61) had chronic back pain (pain "daily" ≥ 6 months at an intensity ≥4/10 scale) and were randomized to an 8-week, 12-session, Cognitive Behavioral Therapy (CBT) or to Supportive Care (SC) matched for frequency, format, and time, with each treatment delivered by a primary care nurse. The primary outcome was the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included the Numerical Rating Scale (NRS) and the Patient Global Impressions Scale (CGI). CBT participants (n=30) showed significant improvements on the RMDQ (means=11.4[5.9] vs. 9.4[6.1] at baseline and post-treatment, respectively, p.10). The results suggest that telehealth, nurse-delivered CBT and SC treatments for chronic back pain can offer significant and relatively comparable benefits. ClinicalTrials.gov: NCT00608530. This article describes the benefits of training primary care nurses to deliver evidence-based behavioral therapies for low back pain. Due to the high prevalence of chronic pain and the growing emphasis on non-opioid therapies, training nurses to provide behavior therapies could be a cost-effective way to improve pain management. Copyright © 2018. Published by Elsevier Inc.

Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.

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Weiss, David M; Casten, Robin J; Leiby, Benjamin E; Hark, Lisa A; Murchison, Ann P; Johnson, Deiana; Stratford, Shayla; Henderer, Jeffrey; Rovner, Barry W; Haller, Julia A

2015-09-01

African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up. Behavioral activation for diabetic retinopathy

Group versus Internet-based cognitive-behavioral therapy for procrastination: Study protocol for a randomized controlled trial

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Alexander Rozental

2014-04-01

Full Text Available Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday lives. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive-behavioral therapy is often deemed a treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the proposed study is therefore to test the efficacy of cognitive-behavioral therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into blocks of thirty will be used, comparing an eight-week Internet-based cognitive-behavioral therapy intervention, and an eight-week group cognitive-behavioral therapy based intervention. It is believed that the proposed study will result in two important findings. First, different treatment interventions in cognitive-behavioral therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both an Internet-based cognitive-behavioral therapy intervention and a group intervention are presumed suitable for administering treatment for procrastination, which is considered important as the availability of adequate care is limited, particularly among students. The proposed study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well

Effects of an HIV peer prevention intervention on sexual and injecting risk behaviors among injecting drug users and their risk partners in Thai Nguyen, Vietnam: a randomized controlled trial.

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Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D; Quan, Vu Minh

2013-11-01

Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p < 0.01) between baseline and the 3-month visit among all index-network member pairs. However, at 12 months, post-intervention, intervention participants had a 14% greater decline in unprotected sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44). Copyright © 2013 Elsevier Ltd. All rights reserved.

Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial.

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Dekker, Kim; Benjamins, Jeroen S; Van Straten, Annemieke; Hofman, Winni F; Van Someren, Eus J W

2015-07-04

DSM-V criteria for insomnia disorder are met by 6 to 10% of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few studies have evaluated the effectiveness of chronobiological treatments, including the timed application of bright light, physical activity and body warming. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most likely represent a heterogeneous mix of subtypes, with different underlying causes and expected treatment responses. The present study aims to evaluate the possibility for optimizing insomnia treatment along the principles of personalized and stratified medicine. It evaluates the following: 1. The relative effectiveness of internet-supported cognitive behavioral therapy, bright light, physical activity and body warming; 2. Whether the effectiveness of internet-supported cognitive behavioral therapy for insomnia can be augmented by simultaneous or prior application of bright light, physical activity and body warming; and 3. Whether the effectiveness of the interventions and their combination are moderated by the insomnia subtype. In a repeated measures, placebo-controlled, randomized clinical trial that included 160 people diagnosed with insomnia disorder, we are evaluating the relative effectiveness of 4 intervention weeks. Primary outcome is subjective sleep efficiency, quantified using a sleep diary. Secondary outcomes include other complaints of sleep and daytime functioning, health-related cost estimates and actigraphic objective sleep estimates. Compliance will be monitored both subjectively and objectively using

A self-determination multiple risk intervention trial to improve smokers' health.

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Williams, Geoffrey C; McGregor, Holly; Sharp, Daryl; Kouldes, Ruth W; Lévesque, Chantal S; Ryan, Richard M; Deci, Edward L

2006-12-01

Little is known about how interventions motivate individuals to change multiple health risk behaviors. Self-determination theory (SDT) proposes that patient autonomy is an essential factor for motivating change. An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested. The Smokers' Health Study is a randomized multiple risk behavior change intervention trial. Smokers were recruited to a tobacco treatment center. A total of 1.006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements. A 6-month clinical intervention (4 contacts) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care. Clinicians elicited patient perspectives and life strivings, provided absolute coronary artery disease risk estimates,enumerated effective treatment options, supported patient initiatives,minimized clinician control, assessed motivation for change, and developed a plan for change. Twelve-month prolonged tobacco abstinence, and change in percent calories from fat and low-density lipoprotein-cholesterol (LDL-C) from baseline to 18 months. RESULTS- Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence (6.2% vs 2.4%; odds ratio [OR]=2.7, P=.01, number needed to treat [NNT] =26), and reduced LDL-C (-8.9 vs -4.1 mg/dL; P=.05). There was no effect on percent calories from fat. An intervention focused on supporting smokers'autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence.

COPING SKILLS IN CHILDREN WITH EPILEPSY--EVALUATION OF COGNITIVE BEHAVIORAL THERAPY INTERVENTION.

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Batista, Maja; Mestrović, Antonela; Vekić, Ana Marija; Malenical, Masa; Kukuruzović, Monika; Begovac, Ivan

2015-12-01

A pilot study was conducted to examine the efficiency and satisfaction of cognitive behavioral therapy (CBT) intervention in youth with epilepsy regarding coping strategies. The CBT intervention was based on the main principles and empirically supported cognitive-behavioral techniques. The intervention consists of epilepsy education, stress education, and coping skill strategies. Seventeen children and adolescents aged 9-17 diagnosed with epilepsy for at least one year, with at least average intelligence and no history of serious mental illness completed the CBT intervention during summer camp, providing data on the efficiency of and satisfaction with CBT intervention. Upon completion of the CBT intervention, study subjects achieved significantly higher scores on the following Scale of Coping with Stress subscales: Problem solving; Seeking for social support from friends; Seeking for social support from family; and Cognitive restructuring, for both measures of usage frequency and effectiveness of each subscale. The participants reported a high level of satisfaction with the CBT intervention. This study provided explanation of research limitations and recommendations for future clinical trials.

Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial.

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Rost, Kathryn M; Marshall, Donna; Xu, Stanley

2014-09-24

Employers can purchase high quality depression products that provide the type, intensity and duration of depression care management shown to improve work outcomes sufficiently for many employers to achieve a return on investment. The purpose of this randomized controlled trial was to test an intervention to encourage employers to purchase a high quality depression product for their workforce. Twenty nine organizations recruited senior health benefit professional members representing public or private employers who had not yet purchased a depression product for all 100+ workers in their company. The research team used randomization blocked by company size to assign eligible employers to: (1) a presentation encouraging employers to purchase a high quality depression product accompanied by a scientifically-derived return on investment estimate, or (2) a presentation encouraging employers to work with their most subscribed health plan to improve depression treatment quality indicators. Two hundred ninety three employers (82.3% of 356) completed baseline data immediately before learning that 140 employers had been randomized to the evidence-based (EB) depression product presentation and 153 had been randomized to the usual care (UC) depression treatment quality indicator presentation. Analysis of 250 (85.3% of 293) employers who completed web-based interviews at 12 and/or 24 months was conducted to determine presentation impact on depression product appraisal and purchasing behavior. The intervention had no impact on depression product appraisal in 232 subjects (F = 2.36, p = .07) or depression product purchasing (chisquare = 1.82, p = .44) in 250 subjects. Depression product appraisal increased in companies with greater health benefit generosity whose benefit professionals were male. Depression product purchasing behavior increased in small companies compared to large companies, companies who knew a vendor that sold depression products at baseline, companies with

Biobehavioral Intervention for Cancer Stress: Conceptualization, Components, and Intervention Strategies

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Andersen, Barbara L.; Golden-Kreutz, Deanna M.; Emery, Charles F.; Thiel, Debora L.

2009-01-01

Trials testing the efficacy of psychological interventions for cancer patients had their beginnings in the 1970s. Since then, hundreds of trials have found interventions to be generally efficacious. In this article, we describe an intervention grounded in a conceptual model that includes psychological, behavioral, and biological components. It is…

Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

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Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

2017-11-09

Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been

Psychometric evaluation of a multi-dimensional measure of satisfaction with behavioral interventions.

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Sidani, Souraya; Epstein, Dana R; Fox, Mary

2017-10-01

Treatment satisfaction is recognized as an essential aspect in the evaluation of an intervention's effectiveness, but there is no measure that provides for its comprehensive assessment with regard to behavioral interventions. Informed by a conceptualization generated from a literature review, we developed a measure that covers several domains of satisfaction with behavioral interventions. In this paper, we briefly review its conceptualization and describe the Multi-Dimensional Treatment Satisfaction Measure (MDTSM) subscales. Satisfaction refers to the appraisal of the treatment's process and outcome attributes. The MDTSM has 11 subscales assessing treatment process and outcome attributes: treatment components' suitability and utility, attitude toward treatment, desire for continued treatment use, therapist competence and interpersonal style, format and dose, perceived benefits of the health problem and everyday functioning, discomfort, and attribution of outcomes to treatment. The MDTSM was completed by persons (N = 213) in the intervention group in a large trial of a multi-component behavioral intervention for insomnia within 1 week following treatment completion. The MDTSM's subscales demonstrated internal consistency reliability (α: .65 - .93) and validity (correlated with self-reported adherence and perceived insomnia severity at post-test). The MDTSM subscales can be used to assess satisfaction with behavioral interventions and point to aspects of treatments that are viewed favorably or unfavorably. © 2017 Wiley Periodicals, Inc.

Computer-Assisted Motivational Interviewing Intervention to Facilitate Teen Pregnancy Prevention and Fitness Behavior Changes: A Randomized Trial for Young Men.

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Bell, David L; Garbers, Samantha; Catallozzi, Marina; Hum, R Stanley; Nechitilo, Meredith; McKeague, Ian W; Koumans, Emilia H; House, L Duane; Rosenthal, Susan L; Gold, Melanie A

2018-03-01

Despite recent declines, teen unintended pregnancy and sexually transmitted infections in the United States remain at levels higher than comparable nations. Initiatives to prevent teen pregnancy have focused primarily on female adolescents; how to effectively engage young men to reduce their risk of fathering a teen pregnancy has not been well studied. We proposed to adapt an innovative computer-assisted motivational interviewing (CAMI) intervention, originally designed and tested with young women, for use with young men, aged 15-24 years, to reduce their risk of fathering a teen pregnancy. This manuscript describes the design of a CAMI intervention for young men aimed at preventing teen pregnancy and improving fitness. This randomized controlled trial will recruit 945 sexually active young men between the ages of 15 and 24 years from three health centers in New York City. Participants will be assigned by permuted block randomization to two study arms: one aimed at reducing involvement in unintended teen pregnancy (CAMI-teen pregnancy prevention) and the other at improving overall fitness (CAMI-Fitness). Except for topic, both intervention arms will provide four sessions of Motivational Interviewing coaching and use a mobile app to track behavior and set goals. We will assess young men's sexual and reproductive health behaviors and fitness at baseline, 12, 24, 36, and 64 weeks using a mobile device app created for the study. Pending ongoing study. Results from the study are expected to enhance our understanding of the efficacy of CAMI to enhance young men's reproductive health and fitness behaviors. Copyright © 2017 Society for Adolescent Health and Medicine. All rights reserved.

A human immunodeficiency virus risk reduction intervention for incarcerated youth: a randomized controlled trial.

Science.gov (United States)

Goldberg, Eudice; Millson, Peggy; Rivers, Stephen; Manning, Stephanie Jeanneret; Leslie, Karen; Read, Stanley; Shipley, Caitlin; Victor, J Charles

2009-02-01

To evaluate, by gender, the impact of a structured, comprehensive risk reduction intervention with and without boosters on human immunodeficiency virus (HIV) knowledge, attitudes and behaviors in incarcerated youth; and to determine predictors of increasing HIV knowledge and reducing high-risk attitudes and behaviors. This randomized controlled trial involved participants completing structured interviews at 1, 3, and 6 months. Repeated measures analysis of variance was used to analyze changes over time. The study was conducted in secure custody facilities and in the community. The study sample comprising 391 incarcerated youth, 102 female and 289 male aged 12-18, formed the voluntary sample. Participants were randomly assigned to one of three conditions: education intervention; education intervention with booster; or no systematic intervention. The outcome and predictor measures included the Rosenberg Self-Esteem Scale, Youth Self Report, Drug Use Inventory, and HIV Knowledge, Attitudes and Behavior Scale. The 6-month retention rate was 59.6%. At 6 months, males in the education and booster groups sustained increases in knowledge scores (p variations by gender underline the importance of gender issues in prevention interventions. Predictors of success were identified to inform future HIV education interventions.

Current Trends in Exercise Intervention Research, Technology, and Behavioral Change Strategies for People With Disabilities: A Scoping Review.

Science.gov (United States)

Lai, Byron; Young, Hui-Ju; Bickel, C Scott; Motl, Robert W; Rimmer, James H

2017-10-01

This review synthesized physical activity and exercise intervention literature for the past 10 yrs for people with physical and cognitive disabilities including intervention characteristics, behavior change strategies, and types of technologies used to improve targeted outcomes. Systematic searches yielded 132 eligible studies. The major disability groups were multiple sclerosis (41%), stroke (15%), and spinal cord injury (12%). Research designs primarily involved randomized controlled trials (61%) versus quasi-experimental designs (39%). Approximately 20% of the interventions used some form of the following technology: information and communication technology (48%), interactive technology (37%), or electronic gauges (30%). Eighteen percent of studies used intervention strategies based on behavioral theory, which was typically combined with technology to promote activity and increase adherence in generally larger study samples. The three prevailing theories included social cognitive theory (58%), supportive accountability theory (21%), and transtheoretical model (21%). Upon completing the intervention, studies reported primarily significant outcomes (80%). Exercise research for PWD has grown in both quantity and quality, but several gaps remain. Study findings provide a roadmap for future exercise trials on understudied populations and highlight technology and behavior change theory as drivers of future intervention research.

Comparison of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial.

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Champion, Jane Dimmitt; Collins, Jennifer L

2012-02-01

Ethnic minority adolescent women with a history of sexual or physical abuse and sexually transmitted infections represent a vulnerable population at risk for HIV. Community-based interventions for behavior modification and subsequent risk reduction have not been effective among these women. To evaluate the effects of a theory-based (AIDS Risk Reduction Model) cognitive behavioral intervention model versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection at 6 and 12 months follow-up. Controlled randomized trial with longitudinal follow-up. Southwestern United States, Metropolitan community-based clinic. Mexican-and-African American adolescent women aged 14-18 years with a history of abuse or sexually transmitted infection seeking sexual health care. Extensive preliminary study for intervention development was conducted including individual interviews, focus groups, secondary data analysis, pre-testing and feasibility testing for modification of an evidence-based intervention prior to testing in the randomized controlled trial. Following informed consents for participation in the trial, detailed interviews concerning demographics, abuse history, sexual risk behavior, sexual health and physical exams were obtained. Randomization into either control or intervention groups was conducted. Intervention participants received workshop, support group and individual counseling sessions. Control participants received abuse and enhanced clinical counseling. Follow-up including detailed interview and physical exam was conducted at 6 and 12 months following study entry to assess for infection. Intention to treat analysis was conducted to assess intervention effects using chi-square and multiple regression models. 409 Mexican-(n=342) and African-(n=67) American adolescent women with abuse and sexually transmitted infection histories were enrolled; 90% intervention group attendance; longitudinal follow-up at 6 (93

Inadequate description of educational interventions in ongoing randomized controlled trials

Directory of Open Access Journals (Sweden)

Pino Cécile

2012-05-01

Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

Frailty Intervention Trial (FIT

Directory of Open Access Journals (Sweden)

Lockwood Keri

2008-10-01

Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

Cancer Patients with Major Depressive Disorder: Testing a Biobehavioral/Cognitive Behavior Intervention

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Brothers, Brittany M.; Yang, Hae-Chung; Strunk, Daniel R.; Andersen, Barbara L.

2011-01-01

Objective: In this Phase II trial, we evaluated a novel psychological treatment for depressed patients coping with the stresses of cancer. Effectiveness of a combined biobehavioral intervention (BBI) and cognitive behavior therapy (CBT) was studied. Method: Participants were 36 cancer survivors (mean age = 49 years; 88% Caucasian; 92% female)…

Using the Intervention Mapping and Behavioral Intervention Technology Frameworks: Development of an mHealth Intervention for Physical Activity and Sedentary Behavior Change.

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Direito, Artur; Walsh, Deirdre; Hinbarji, Moohamad; Albatal, Rami; Tooley, Mark; Whittaker, Robyn; Maddison, Ralph

2018-06-01

Few interventions to promote physical activity (PA) adapt dynamically to changes in individuals' behavior. Interventions targeting determinants of behavior are linked with increased effectiveness and should reflect changes in behavior over time. This article describes the application of two frameworks to assist the development of an adaptive evidence-based smartphone-delivered intervention aimed at influencing PA and sedentary behaviors (SB). Intervention mapping was used to identify the determinants influencing uptake of PA and optimal behavior change techniques (BCTs). Behavioral intervention technology was used to translate and operationalize the BCTs and its modes of delivery. The intervention was based on the integrated behavior change model, focused on nine determinants, consisted of 33 BCTs, and included three main components: (1) automated capture of daily PA and SB via an existing smartphone application, (2) classification of the individual into an activity profile according to their PA and SB, and (3) behavior change content delivery in a dynamic fashion via a proof-of-concept application. This article illustrates how two complementary frameworks can be used to guide the development of a mobile health behavior change program. This approach can guide the development of future mHealth programs.

Obesity prevention and obesogenic behavior interventions in child care: A systematic review.

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Sisson, Susan B; Krampe, Megan; Anundson, Katherine; Castle, Sherri

2016-06-01

Review peer-reviewed interventions designed to reduce obesity and improve obesogenic behaviors, including physical activity, diet, and screen time, at child care centers. Interventions components and outcomes, study design, duration, use of behavioral theory, and level of social ecological influence are detailed. Article searches were conducted from March 2014, October 2014, March 2015, January 2016 across three databases. Eligible interventions were conducted in child care settings, included 3-to-5-year-old children, included an outcome measure of obesity or obesogenic behavior, and published in English. Study design quality was assessed using Stetler's Level of Quantitative Evidence. All unique records were screened (n=4589): 237 articles were assessed for eligibility. Of these, 97 articles describing 71 interventions met inclusion criteria. Forty-four articles included multi-level interventions. Twenty-nine interventions included an outcome measure of obesity. Forty-one interventions included physical activity. Forty-five included diet. Eight included screen time. Fifty-five percent of interventions were Level II (randomized controlled trials), while 37% were Level III (quasi-experimental or pre-post only study design), and 8% were Level IV (non-experimental or natural experiments). Most interventions had the intended effect on the target: obesity 48% (n=14), physical activity 73% (n=30), diet 87% (n=39), and screen time 63% (n=5). Summarizing intervention strategies and assessing their effectiveness contributes to the existing literature and may provide direction for practitioners and researchers working with young children in child care. Most interventions produced the targeted changes in obesity and obesity-associated behaviors, supporting current and future efforts to collaborate with early-care centers and professionals for obesity prevention. Copyright © 2016 Elsevier Inc. All rights reserved.

The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia: a randomized controlled trial.

Science.gov (United States)

Prick, Anna-Eva; de Lange, Jacomine; Scherder, Erik; Twisk, Jos; Pot, Anne Margriet

2016-01-01

The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia living in the community were evaluated in a randomized controlled trial. This multicomponent dyadic intervention is a translated and adapted version of an intervention that has been shown to be effective for people with dementia in the US. People with dementia living in the community and their family caregivers (N=111 caregiver-care recipient dyads) were randomly assigned to the intervention and comparison group. The intervention group received home-based physical exercise training, psycho-education, communication skills training, and pleasant activities training during 3 months directed at both the person with dementia and the caregiver. Mood, behavior, and physical health were measured at baseline, 3 months, and 6 months. The effects of the study were determined by using generalized estimating equations based on an intention-to-treat analysis. Analyses showed no beneficial effects over time on any of the outcome measures. This study showed no effects. The negative results in this study compared to the study that has been carried out in the US might be explained by the translation, adaptation, and shortening of the intervention used in the US, and a different social context. In addition, the results might be explained by the lack of room for improvement and by experiencing the intervention as too much of a burden. Furthermore, improving physical health might only be effective if the physical exercises are of moderate-to-high-intensity and are tailored in accordance with participants' preferences and needs. For future studies, because dyads often commented positively about the pleasure and support they received, it might also be valuable to measure quality of life outcomes such as relationship quality, pleasure, and self-esteem in dyadic focused interventions.

How completely are physiotherapy interventions described in reports of randomised trials?

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Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M

2016-06-01

Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program.

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Koutoukidis, Dimitrios A; Lopes, Sonia; Atkins, Lou; Croker, Helen; Knobf, M Tish; Lanceley, Anne; Beeken, Rebecca J

2018-03-27

About 80% of endometrial cancer survivors (ECS) are overweight or obese and have sedentary behaviors. Lifestyle behavior interventions are promising for improving dietary and physical activity behaviors, but the constructs associated with their effectiveness are often inadequately reported. The aim of this study was to systematically adapt an evidence-based behavior change program to improve healthy lifestyle behaviors in ECS. Following a review of the literature, focus groups and interviews were conducted with ECS (n = 16). An intervention mapping protocol was used for the program adaptation, which consisted of six steps: a needs assessment, formulation of matrices of change objectives, selection of theoretical methods and practical applications, program production, adoption and implementation planning, and evaluation planning. Social Cognitive Theory and Control Theory guided the adaptation of the intervention. The process consisted of eight 90-min group sessions focusing on shaping outcome expectations, knowledge, self-efficacy, and goals about healthy eating and physical activity. The adapted performance objectives included establishment of regular eating, balanced diet, and portion sizes, reduction in sedentary behaviors, increase in lifestyle and organized activities, formulation of a discrepancy-reducing feedback loop for all above behaviors, and trigger management. Information on managing fatigue and bowel issues unique to ECS were added. Systematic intervention mapping provided a framework to design a cancer survivor-centered lifestyle intervention. ECS welcomed the intervention and provided essential feedback for its adaptation. The program has been evaluated through a randomized controlled trial.

Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

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Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

2014-01-01

Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

Behavioral interventions in patients with an implantable cardioverter defibrillator

DEFF Research Database (Denmark)

Habibović, Mirela; Burg, Matthew M; Pedersen, Susanne S.

2013-01-01

The implantable cardioverter defibrillator (ICD) is the first-line treatment for primary and secondary prevention of sudden cardiac death. A subgroup of patients experience psychological distress postimplant, and no clear evidence base exists regarding how best to address patients' needs. The aim...... of this critical review is to provide an overview of behavioral interventions in ICD patients to date, and to delineate directions for future research using lessons learned from the ongoing RISTA and WEBCARE trials....

What is the benefit of the biomedical and behavioral interventions in preventing HIV transmission?

Directory of Open Access Journals (Sweden)

Ricardo Kuchenbecker

2015-09-01

Full Text Available ABSTRACTIntroduction:Scientific evidence supports the sinergy between biomedical and behavioral interventions aimed at preventing the transmission of HIV as a strategy to eradicate AIDS.Objective:To characterize comparatively the benefits from biomedical and behavioral interventions to prevent HIV transmission.Methods:Narrative review. We performed a comparative analysis of the benefits of studied interventions by means of estimating the number needed to treat (NNT. Evaluated interventions: counseling activities for behavior change to prevent exposure to HIV; antiretroviral pre-exposure prophylaxis (PrEP and antiretroviral post-exposure prophylasis (PEP for HIV and treatment of serodiscordant couples as a strategy for prevention of HIV transmission (TasP.Results:counseling interventions and TasP have smaller NNTs, equal to, respectively, 11 (95%CI 9 - 18 at 12 months and 34 (95%CI 23 - 54 in 42 months comparatively to PrEP interventions, that resulted in 41 (95%CI 28 - 67 individuals receiving antiretrovirals in order to prevent one case of HIV infection at 36 months for men and serodiscordant couples. PEP interventions are associated with protective effects estimated at 81%. Lack of trials evaluating PEP prevents estimate of NNT.Conclusion:The estimate of the NNT can be a helpful parameter in the comparison between the effectiveness of different behavioral and biomedical HIV prevention strategies. Studies evaluating the benefit and safety of combined behavioral and biomedical interventions are needed, especially considering the attributable fraction of each component. Integration of behavioral and biomedical interventions is required to achieve complete suppression of the virus, and thus reducing viral replication, infectivity and the number of cases.

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach.

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Amorrortu, Rossybelle P; Arevalo, Mariana; Vernon, Sally W; Mainous, Arch G; Diaz, Vanessa; McKee, M Diane; Ford, Marvella E; Tilley, Barbara C

2018-02-17

Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan. The intervention included five educational modules, one in-person and four web-based, plus technical assistance calls to coordinators. Modules addressed the intervention rationale, development of clinic-specific plans to obtain minority-serving physician referrals, physician-centered and patient-centered communication, and patient navigation. The evaluation, a randomized trial, was recently completed in 50 specialty clinics and is under analysis. Using IM we developed a recruitment intervention that focused on building relationships with minority-serving physicians to encourage minority patient referrals. IM enhanced our understanding of factors that may influence minority recruitment and helped us integrate strategies from multiple disciplines that were relevant for our audience.

Randomized trial of behavior therapy for adults with Tourette syndrome.

Science.gov (United States)

Wilhelm, Sabine; Peterson, Alan L; Piacentini, John; Woods, Douglas W; Deckersbach, Thilo; Sukhodolsky, Denis G; Chang, Susanna; Liu, Haibei; Dziura, James; Walkup, John T; Scahill, Lawrence

2012-08-01

Tics in Tourette syndrome begin in childhood, peak in early adolescence, and often decrease by early adulthood. However, some adult patients continue to have impairing tics. Medications for tics are often effective but can cause adverse effects. Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults. To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity. A randomized controlled trial with posttreatment evaluations at 3 and 6 months for positive responders. Three outpatient research clinics. Patients (N = 122; 78 males; age range, 16-69 years) with Tourette syndrome or chronic tic disorder were recruited between December 27, 2005, and May 21, 2009. Patients received 8 sessions of comprehensive behavioral intervention for tics or 8 sessions of supportive treatment for 10 weeks. Patients with a positive response were given 3 monthly booster sessions. Total tic score on the Yale Global Tic Severity Scale and the Clinical Global Impression-Improvement scale rated by a clinician masked to treatment assignment. Behavior therapy was associated with a significantly greater mean (SD) decrease on the Yale Global Tic Severity Scale (24.0 [6.47] to 17.8 [7.32]) from baseline to end point compared with the control treatment (21.8 [6.59] to 19.3 [7.40]) (P Tourette syndrome. clinicaltrials.gov Identifier: NCT00231985.

Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury.

Science.gov (United States)

Cogan, Alison M; Blanchard, Jeanine; Garber, Susan L; Vigen, Cheryl Lp; Carlson, Mike; Clark, Florence A

2017-07-01

To investigate the efficacy of behavioral or educational interventions in preventing pressure ulcers in community-dwelling adults with spinal cord injury (SCI). Cochrane, Clinical Trials, PubMed, and Web of Science were searched in June 2016. The search combined related terms for pressure ulcers, spinal cord injury, and behavioral intervention. Each database was searched from its inception with no restrictions on year of publication. Inclusion criteria required that articles were (a) published in a peer-reviewed journal in English, (b) evaluated a behavioral or educational intervention for pressure ulcer prevention, (c) included community-dwelling adult participants aged 18 years and older with SCI, (d) measured pressure ulcer occurrence, recurrence, or skin breakdown as an outcome, and (e) had a minimum of 10 participants. All study designs were considered. Two reviewers independently screened titles and abstracts. Extracted information included study design, sample size, description of the intervention and control condition, pressure ulcer outcome measures, and corresponding results. The search strategy yielded 444 unique articles of which five met inclusion criteria. Three were randomized trials and two were quasi-experimental designs. A total of 513 participants were represented. The method of pressure ulcer or skin breakdown measurement varied widely among studies. Results on pressure ulcer outcomes were null in all studies. Considerable methodological problems with recruitment, intervention fidelity, and participant adherence were reported. At present, there is no positive evidence to support the efficacy of behavioral or educational interventions in preventing pressure ulcer occurrence in adults with SCI.

The Healthy Toddlers Trial Protocol: An Intervention to Reduce Risk Factors for Childhood Obesity in Economically and Educationally Disadvantaged Populations

Directory of Open Access Journals (Sweden)

Auld Garry

2011-07-01

Full Text Available Abstract Background The number of overweight children in America has doubled to an estimated 10 million in the past 20 years. Establishing healthy dietary behaviors must begin early in childhood and include parents. The Healthy Toddlers intervention focuses on promoting healthy eating habits in 1- to 3-year-old children utilizing the Social Cognitive Theory and a learner-centered approach using Adult Learning principles. This Healthy Toddlers Trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mothers of toddlers. The intervention focuses on: (a promoting healthy eating behaviors in toddlers while dietary habits are forming; and (b providing initial evidence for the potential of Healthy Toddlers as a feasible intervention within existing community-based programs. Methods/Design This describes the study protocol for a randomized control trial, a multi-state project in Colorado, Michigan, and Wisconsin with economically and educationally disadvantaged mother-toddler dyads; toddlers are between 12 and 36 months. The Healthy Toddlers intervention consists of eight in-home lessons and four reinforcement telephone contacts, focusing on fruit, vegetable, and sweetened beverage consumption and parental behaviors, taught by paraprofessional instructors. Healthy Toddlers uses a randomized, experimental, short-term longitudinal design with intervention and control groups. In-home data collection (anthropometric measurements, feeding observations, questionnaires, 3-day dietary records occurs at baseline, immediately following the intervention, and 6 months after the intervention. Main toddler outcomes include: a increased fruit and vegetable consumption and decreased sweetened beverage consumption; and b improved toddler-eating skills (self-feeding and self-serving. Main parent outcomes include: a improved psychosocial attributes (knowledge

Community-led trials: Intervention co-design in a cluster randomised controlled trial.

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Andersson, Neil

2017-05-30

In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

Community-led trials: Intervention co-design in a cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Neil Andersson

2017-05-01

Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

Science.gov (United States)

Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

2014-01-01

Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

Rationale and design: telephone-delivered behavioral skills interventions for Blacks with type 2 diabetes

Directory of Open Access Journals (Sweden)

Strom Joni L

2010-03-01

Full Text Available Abstract Background African Americans with Type 2 diabetes (T2DM have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Americans with T2DM can be attributed to patient, provider, and health systems level factors. Provider and health system factors account for Methods/Design We describe an ongoing four-year randomized clinical trial, using a 2 × 2 factorial design, which will test the efficacy of separate and combined telephone-delivered, diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM (HbA1c ≥ 9%. Two-hundred thirty-two (232 male and female African-American participants, 18 years of age or older and with an HbA1c ≥ 9%, will be randomized into one of four groups for 12-weeks of phone interventions: (1 an education group, (2 a motivation/skills group, (3 a combined group or (4 a usual care/general health education group. Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among African Americans with poorly controlled T2DM, patients randomized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group. Discussion Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM. Trial registration National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT00929838.

Design and protocol of a randomized multiple behavior change trial: Make Better Choices 2 (MBC2).

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Pellegrini, Christine A; Steglitz, Jeremy; Johnston, Winter; Warnick, Jennifer; Adams, Tiara; McFadden, H G; Siddique, Juned; Hedeker, Donald; Spring, Bonnie

2015-03-01

Suboptimal diet and inactive lifestyle are among the most prevalent preventable causes of premature death. Interventions that target multiple behaviors are potentially efficient; however the optimal way to initiate and maintain multiple health behavior changes is unknown. The Make Better Choices 2 (MBC2) trial aims to examine whether sustained healthful diet and activity change are best achieved by targeting diet and activity behaviors simultaneously or sequentially. Study design approximately 250 inactive adults with poor quality diet will be randomized to 3 conditions examining the best way to prescribe healthy diet and activity change. The 3 intervention conditions prescribe: 1) an increase in fruit and vegetable consumption (F/V+), decrease in sedentary leisure screen time (Sed-), and increase in physical activity (PA+) simultaneously (Simultaneous); 2) F/V+ and Sed- first, and then sequentially add PA+ (Sequential); or 3) Stress Management Control that addresses stress, relaxation, and sleep. All participants will receive a smartphone application to self-monitor behaviors and regular coaching calls to help facilitate behavior change during the 9 month intervention. Healthy lifestyle change in fruit/vegetable and saturated fat intakes, sedentary leisure screen time, and physical activity will be assessed at 3, 6, and 9 months. MBC2 is a randomized m-Health intervention examining methods to maximize initiation and maintenance of multiple healthful behavior changes. Results from this trial will provide insight about an optimal technology supported approach to promote improvement in diet and physical activity. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: simultaneous care educational intervention (SCEI): linking palliation and clinical trials.

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Meyers, Frederick J; Carducci, Michael; Loscalzo, Matthew J; Linder, John; Greasby, Tamara; Beckett, Laurel A

2011-04-01

Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. To examine the effect of a standardized cognitive-behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms (p = 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm (p = 0.02). The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time.

Adaptive Intervention Design in Mobile Health: Intervention Design and Development in the Cell Phone Intervention for You (CITY) Trial

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Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

2015-01-01

Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to

The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity

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Karen J. Campbell

2016-02-01

Full Text Available Abstract Background Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. Methods/Design The Infant Feeding Activity and Nutrition Trial (InFANT Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month and enhanced (use of web-based materials, and Facebook® engagement, version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. Discussion This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. Trial registration ACTRN12611000386932 . Registered 13 April 2011.

The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

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Buist A

2010-03-01

Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

Behavioral Interventions Targeting Chronic Pain, Depression, and Substance Use Disorder in Primary Care.

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Barrett, Kathleen; Chang, Yu-Ping

2016-07-01

Patients with chronic pain, depression, and substance use disorder (SUD) are often treated in primary care settings. An estimated 52% of patients have a diagnosis of chronic pain, 5% to 13% have depression, and 19% have SUD. These estimates are likely low when considering the fact that 50% of primary care patients with depression and 65% with SUD are undiagnosed or do not seek help. These three conditions have overlapping neurophysiological processes, which complicate the treatment outcomes of a primary physical illness. Behavioral interventions have been widely utilized as adjunctive treatments, yet little is known about what types of behavioral interventions were effective to treat these comorbidities. This systematic review aimed to identify behavioral interventions targeting chronic pain, depression, and SUD in primary care settings. The Cumulative Index to Nursing and Allied Health Literature, Medline, PsycInfo, and Google Scholar databases were searched to identify randomized controlled trials, using a behavioral intervention, involving adults with at least two of the three conditions. This search yielded 1,862 relevant records, and six articles met final selection criteria. A total of 696 participants were studied. Behavioral interventions varied in content, format, and duration. Mindfulness Oriented Recovery Enhancement (MORE), Acceptance and Commitment Therapy (ACT), Interpersonal Psychotherapy adapted for pain (IPT-P), and Cognitive Behavioral Therapy (CBT) showed promising improvements across all studies, albeit with small to moderate effects. MORE, ACT, and CBT combined with mindfulness and Motivational Interviewing had the most promising results for treating chronic pain, depression, and SUD in various combinations in primary care settings. The evidence is mounting that behavioral interventions such as mindfulness-based or cognitive-behavioral interventions are effective strategies for managing patients with comorbidities of chronic pain, depression

School-based intervention for childhood disruptive behavior in disadvantaged settings: a randomized controlled trial with and without active teacher support.

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Liber, Juliette M; De Boo, Gerly M; Huizenga, Hilde; Prins, Pier J M

2013-12-01

In this randomized controlled trial, we investigated the effectiveness of a school-based targeted intervention program for disruptive behavior. A child-focused cognitive behavioral therapy (CBT) program was introduced at schools in disadvantaged settings and with active teacher support (ATS) versus educational teacher support (ETS) (CBT + ATS vs. CBT + ETS). Screening (n = 1,929) and assessment (n = 224) led to the inclusion of 173 children ages 8-12 years from 17 elementary schools. Most of the children were boys (n = 136, 79%) of low or low-to-middle class socioeconomic status (87%); the sample was ethnically diverse (63% of non-Western origin). Children received CBT + ATS (n = 29) or CBT + ETS (n = 41) or were entered into a waitlist control condition (n = 103) to be treated afterward (CBT + ATS, n = 39, and CBT + ETS, n = 64). Effect sizes (ES), clinical significance (reliable change), and the results of multilevel modeling are reported. Ninety-seven percent of children completed treatment. Teachers and parents reported positive posttreatment effects (mean ES = .31) for CBT compared with the waitlist control condition on disruptive behavior. Multilevel modeling showed similar results. Clinical significance was modest. Changes had remained stable or had increased at 3-months follow-up (mean ES = .39). No consistent effect of teacher condition was found at posttreatment; however, at follow-up, children who received ETS fared significantly better. This study shows that a school-based CBT program is beneficial for difficult-to-reach children with disruptive behavior: The completion rate was remarkably high, ESs (mean ES = .31) matched those of previous studies with targeted intervention, and effects were maintained or had increased at follow-up.

PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

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Michele R. Sgambato

2016-08-01

Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

Intervention Effects on Safety Compliance and Citizenship Behaviors: Evidence from the Work, Family, and Health Study

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Hammer, Leslie B.; Johnson, Ryan C.; Crain, Tori L.; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly; Kelly, Erin L.; Buxton, Orfeu M.; Karuntzos, Georgia; Chosewood, L. Casey; Berkman, Lisa

2015-01-01

We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 healthcare facilities using a group-randomized trial. Based on Conservation of Resources theory and the Work-Home Resources Model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family and employee control over work time would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline, 6-month and 12-month post-intervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month and organizational citizenship behaviors at the 12-month follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors, compared to employees in the control facilities. The hypothesized mediators of perceptions of family supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. PMID:26348479

Theory of reasoned action and theory of planned behavior-based dietary interventions in adolescents and young adults: a systematic review.

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Hackman, Christine L; Knowlden, Adam P

2014-01-01

Childhood obesity has reached epidemic proportions in many nations around the world. The theory of planned behavior (TPB) and the theory of reasoned action (TRA) have been used to successfully plan and evaluate numerous interventions for many different behaviors. The aim of this study was to systematically review and synthesize TPB and TRA-based dietary behavior interventions targeting adolescents and young adults. THE FOLLOWING DATABASES WERE SYSTEMATICALLY SEARCHED TO FIND ARTICLES FOR THIS REVIEW: Academic Search Premier; Cumulative Index to Nursing and Allied Health (CINAHL); Education Resources Information Center (ERIC); Health Source: Nursing/Academic Edition; Cochrane Central Register of Controlled Trials (CENTRAL); and MEDLINE. Inclusion criteria for articles were: 1) primary or secondary interventions, 2) with any quantitative design, 3) published in the English language, 4) between January 2003 and March 2014, 5) that targeted adolescents or young adults, 6) which included dietary change behavior as the outcome, and 7) utilized TPB or TRA. Of the eleven intervention studies evaluated, nine resulted in dietary behavior change that was attributed to the treatment. Additionally, all but one study found there to be a change in at least one construct of TRA or TPB, while one study did not measure constructs. All of the studies utilized some type of quantitative design, with two employing quasi-experimental, and eight employing randomized control trial design. Among the studies, four utilized technology including emails, social media posts, information on school websites, web-based activities, audio messages in classrooms, interactive DVDs, and health-related websites. Two studies incorporated goal setting and four employed persuasive communication. Interventions directed toward changing dietary behaviors in adolescents should aim to incorporate multi-faceted, theory-based approaches. Future studies should consider utilizing randomized control trial design and

Integrating technology into complex intervention trial processes: a case study.

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Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

2016-11-17

Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

Randomized trial of a population-based, home-delivered intervention for preschool language delay.

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Wake, Melissa; Tobin, Sherryn; Levickis, Penny; Gold, Lisa; Ukoumunne, Obioha C; Zens, Naomi; Goldfeld, Sharon; Le, Ha; Law, James; Reilly, Sheena

2013-10-01

Population approaches to lessen the adverse impacts of preschool language delay remain elusive. We aimed to determine whether systematic ascertainment of language delay at age 4 years, followed by a 10-month, 1-on-1 intervention, improves language and related outcomes at age 5 years. A randomized trial nested within a cross-sectional ascertainment of language delay. Children with expressive and/or receptive language scores more than 1.25 SD below the mean at age 4 years entered the trial. Children randomly allocated to the intervention received 18 1-hour home-based therapy sessions. The primary outcomes were receptive and expressive language (Clinical Evaluation of Language Fundamentals - Preschool, 2(nd) Edition) and secondary outcomes were child phonological skills, letter awareness, pragmatic skills, behavior, and quality of life. A total of 1464 children were assessed for language delay at age 4 years. Of 266 eligible children, 200 (13.6%) entered the trial, with 91 intervention (92% of 99) and 88 control (87% of 101) children retained at age 5 years. At age 5 years, there was weak evidence of benefit to expressive (adjusted mean difference, intervention - control, 2.0; 95% confidence interval [CI] -0.5 to 4.4; P = .12) but not receptive (0.6; 95% CI -2.5 to 3.8; P = .69) language. The intervention improved phonological awareness skills (5.0; 95% CI 2.2 to 7.8; P language intervention was successfully delivered by non-specialist staff, found to be acceptable and feasible, and has the potential to improve long-term consequences of early language delay within a public health framework.

A behavioral medicine intervention for community-dwelling older adults with chronic musculoskeletal pain: protocol for a randomized controlled trial

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Cederbom S

2017-04-01

Full Text Available Sara Cederbom,1 Eva Denison,2 Astrid Bergland1 1Department of Physiotherapy, Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway; 2Department of Physiotherapy, School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden Background: Chronic musculoskeletal pain is a major health problem among older adults, particularly those who live alone and/or those who are dependent on formal care. Chronic pain is associated with mobility problems, falls, fear of falling, catastrophizing thoughts, and a lower quality of life. Research shows that physical therapy interventions based on behavioral medicine approaches are beneficial for middle-aged adults with chronic pain. However, there appears to be no previous randomized controlled trials (RCTs based on this theoretical framework that have examined the effect on older adults with chronic musculoskeletal pain who live alone at home and are dependent on formal care to manage their everyday lives. The aim of the planned study is to evaluate the effect of an individually tailored integrated physical therapy intervention based on a behavioral medicine approach compared with the effect of standard care.Methods/design: The planned study is an RCT that will include one intervention and one control group involving a total of 150 adults aged ≥75 years with chronic musculoskeletal pain who live alone at home and are dependent on formal care to manage their everyday lives. The intervention will involve a 12-week home-based individually tailored intervention that will be designed to enhance the participants’ ability to perform everyday activities by improving physical function and reducing pain-related disability and beliefs. The control group will be given standard care, including general advice about physical activity. The participants will be assessed at baseline and at 3 and 6 months after baseline. The primary outcome will be pain

Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial

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Ly Kien

2012-05-01

Full Text Available Abstract Background The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones. Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment. Methods The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, ‘Effective meditation’. The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period. Discussions We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist’s prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10�

Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial.

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Anderson, Cheryl A M; Cobb, Laura K; Miller, Edgar R; Woodward, Mark; Hottenstein, Annette; Chang, Alex R; Mongraw-Chaffin, Morgana; White, Karen; Charleston, Jeanne; Tanaka, Toshiko; Thomas, Letitia; Appel, Lawrence J

2015-09-01

For decades, dietary sodium intake in the United States has remained high, and few studies have examined strategies for maintaining recommended intakes. We examined the effects of a behavioral intervention, which emphasized spices and herbs, on the maintenance of sodium intake at the recommended intake of 1500 mg/d in individuals to whom the US Dietary Guidelines for Americans apply. We conducted a 2-phase study that included adults ≥18 y of age for whom Dietary Guidelines for Americans recommends 1500 mg Na/d. The study was conducted in Baltimore, Maryland, from 2012 to 2014. In phase 1, 55 individuals consumed a low-sodium diet for 4 wk. Participants were provided all foods, snacks, and calorie-containing drinks. In phase 2, 40 participants from phase 1 were randomly assigned to either a behavioral intervention to reduce sodium intake (n = 20) or a self-directed control group (n = 20) for 20 wk. The primary study outcome was the change in mean 24-h urinary sodium excretion during phase 2. Linear regression analyses were used to determine intervention effects on urinary sodium excretion. Participant characteristics were as follows: women: 65%; African American: 88%; hypertension: 63%; diabetes: 18%; mean age: 61 y; and mean body mass index (in kg/m(2)): 30. At the end of phase 2, mean 24-h sodium excretion was lower in the behavioral intervention than in the self-directed group (mean difference: -956.8 mg/d; 95% CI: -1538.7, -374.9 mg/d) after sodium intake at screening was controlled for (P = 0.002). These findings persisted in sensitivity analyses that excluded potentially incomplete urine collections [Mage's equation mean difference: -1090 mg/d (P = 0.001); Joosens' equation mean difference: -796 mg/d (P = 0.04)]. A multifactorial behavioral intervention emphasizing spices and herbs significantly reduced sodium intake. Because of the ubiquity of sodium in the US food supply, multilevel strategies addressing individual behaviors and the food supply are needed

Theory of reasoned action and theory of planned behavior-based dietary interventions in adolescents and young adults: a systematic review

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Hackman CL

2014-06-01

Full Text Available Christine L Hackman, Adam P KnowldenDepartment of Health Science, The University of Alabama, Tuscaloosa, AL, USABackground: Childhood obesity has reached epidemic proportions in many nations around the world. The theory of planned behavior (TPB and the theory of reasoned action (TRA have been used to successfully plan and evaluate numerous interventions for many different behaviors. The aim of this study was to systematically review and synthesize TPB and TRA-based dietary behavior interventions targeting adolescents and young adults.Methods: The following databases were systematically searched to find articles for this review: Academic Search Premier; Cumulative Index to Nursing and Allied Health (CINAHL; Education Resources Information Center (ERIC; Health Source: Nursing/Academic Edition; Cochrane Central Register of Controlled Trials (CENTRAL; and MEDLINE. Inclusion criteria for articles were: 1 primary or secondary interventions, 2 with any quantitative design, 3 published in the English language, 4 between January 2003 and March 2014, 5 that targeted adolescents or young adults, 6 which included dietary change behavior as the outcome, and 7 utilized TPB or TRA.Results: Of the eleven intervention studies evaluated, nine resulted in dietary behavior change that was attributed to the treatment. Additionally, all but one study found there to be a change in at least one construct of TRA or TPB, while one study did not measure constructs. All of the studies utilized some type of quantitative design, with two employing quasi-experimental, and eight employing randomized control trial design. Among the studies, four utilized technology including emails, social media posts, information on school websites, web-based activities, audio messages in classrooms, interactive DVDs, and health-related websites. Two studies incorporated goal setting and four employed persuasive communication.Conclusion: Interventions directed toward changing dietary behaviors

Testing a workplace physical activity intervention: a cluster randomized controlled trial.

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McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M

2011-04-11

Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.

Assessing the Impact of De Novo Social Ties within Health Intervention Settings: New Questions for Health Behavior Intervention Research.

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Tesdahl, Eric; Gesell, Sabina B

2015-12-01

Recent developments in the study of health and social networks have focused on linkages between health outcomes and naturally occurring social relations, such as friendship or kinship. Based on findings in this area, a new generation of health behavior intervention programs have been implemented that rely on the formation of new social relations among program participants. However, little is known about the qualities of these de novo social relations. We examined the social networks of 59 participants within a randomized controlled trial of an intervention designed to prevent excessive gestational weight gain. We employed exponential random graph modeling techniques to analyze supportive relationships formed between participants in the intervention arm, to detect unique effects of program participation on the likelihood of forming ties. Program participation had a positive effect on the likelihood of forming supportive social relations, however, in this particular timeframe we did not detect any additional effect of such relations on the health behaviors or outcomes of interest. Our findings raise two critical questions: do short-term group-level programs reliably lead to the formation of new social relations among participants; and do these relations have a unique effect on health outcomes relative to standard methods of health behavior intervention? © 2015 Wiley Periodicals, Inc.

Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

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Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

2016-06-01

To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

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Prchal Alice

2012-01-01

Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

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Suzuki Yuriko

2008-09-01

Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.

Behavioral Reactivity Associated With Electronic Monitoring of Environmental Health Interventions--A Cluster Randomized Trial with Water Filters and Cookstoves.

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Thomas, Evan A; Tellez-Sanchez, Sarita; Wick, Carson; Kirby, Miles; Zambrano, Laura; Abadie Rosa, Ghislaine; Clasen, Thomas F; Nagel, Corey

2016-04-05

Subject reactivity--when research participants change their behavior in response to being observed--has been documented showing the effect of human observers. Electronics sensors are increasingly used to monitor environmental health interventions, but the effect of sensors on behavior has not been assessed. We conducted a cluster randomized controlled trial in Rwanda among 170 households (70 blinded to the presence of the sensor, 100 open) testing whether awareness of an electronic monitor would result in a difference in weekly use of household water filters and improved cookstoves over a four-week surveillance period. A 63% increase in number of uses of the water filter per week between the groups was observed in week 1, an average of 4.4 times in the open group and 2.83 times in the blind group, declining in week 4 to an insignificant 55% difference of 2.82 uses in the open, and 1.93 in the blind. There were no significant differences in the number of stove uses per week between the two groups. For both filters and stoves, use decreased in both groups over four-week installation periods. This study suggests behavioral monitoring should attempt to account for reactivity to awareness of electronic monitors that persists for weeks or more.

The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial

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Clare Linda

2012-07-01

Full Text Available Abstract Background Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. Methods/design This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75 will be randomized to one of three conditions: control (an interview involving a general discussion about the center; goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement; or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring. All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life, cognitive (memory and executive function, and physical fitness (functional and metabolic domains. Cost-effectiveness will also be examined. Discussion This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Trial Registration Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com

Effects of the KEEP Foster Parent Intervention on Child and Sibling Behavior Problems and Parental Stress During a Randomized Implementation Trial.

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Price, Joseph M; Roesch, Scott; Walsh, Natalia E; Landsverk, John

2015-07-01

Children in foster care are at risk for externalizing behavior problems, which can in turn increase the risk of changes in foster care placement. The KEEP (Keeping Foster Parents Trained and Supported) foster parent training intervention was designed to equip foster parents with strategies for managing externalizing behavior problems. The primary goals of this investigation were to (a) examine the effectiveness of the KEEP intervention in reducing child behavior problems, as delivered by a community agency; (b) determine if the effects of the KEEP intervention generalize to more than one child in the same home; and (c) examine the effectiveness of the KEEP intervention in reducing parental stress associated with child behavior problems. The data from 335 foster and kinship families with children between the ages of 5 and 12 years were analyzed to address these objectives. Families were randomly assigned to the intervention or control condition. The results indicated that the KEEP intervention was effective in reducing child behavior problems when delivered by a community agency. These results expanded prior research on the KEEP intervention, revealing that the intervention was effective in reducing the behavior problems of more than one child in the same household and in reducing parental stress levels associated with the behavioral issues of the focal child. Thus, the KEEP intervention model holds promise for reducing the behavior problems of children in foster care and reducing stress levels of foster and kinship caregivers as it is disseminated and implemented within similar child welfare settings.

Verbal Bullying Changes Among Students Following an Educational Intervention Using the Integrated Model for Behavior Change.

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Naidoo, Saloshni; Satorius, Benn K; de Vries, Hein; Taylor, Myra

2016-11-01

Bullying behavior in schools can lead to psychosocial problems. School-based interventions are important in raising student awareness, developing their skills and in planning to reduce bullying behavior. A randomized controlled trial, using a school-based educational intervention to reduce verbal bullying, was conducted among grade 10 students in 16 urban and rural schools in KwaZulu-Natal, South Africa in 2013. Baseline and postintervention questionnaires, developed using the Integrated Model for Behavior Change theoretical model, were used to assess changes in verbal bullying. Postintervention there were reduced verbal bullying experiences. Improved social norms and awareness of verbal bullying were associated with reduced verbal bullying experiences and behavior. Although less likely to bully others verbally, girls were more likely to experience verbal bullying. Students with no living father were more likely to bully others verbally. The study findings indicate that a school-based intervention can positively impact on verbal bullying experiences and behavior. © 2016, American School Health Association.

A Peer-Led, Social Media-Delivered, Safer Sex Intervention for Chinese College Students: Randomized Controlled Trial.

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Sun, Wai Han; Wong, Carlos King Ho; Wong, William Chi Wai

2017-08-09

The peer-led, social media-delivered intervention is an emerging method in sexual health promotion. However, no research has yet investigated its effectiveness as compared with other online channels or in an Asian population. The objective of this study is to compare a peer-led, social media-delivered, safer sex intervention with a sexual health website. Both conditions target Chinese college students in Hong Kong. A randomized controlled trial was conducted with a peer-led, safer sex Facebook group as the intervention and an existing online sexual health website as the control. The intervention materials were developed with peer input and followed the information-motivation-behavioral skills model; the intervention was moderated by peer educators. The participants filled out the online questionnaires before and after the 6-week intervention period. Outcome evaluations included safer sex attitudes, behavioral skills, and behaviors, while process evaluation focused on online experience, online-visiting frequency, and online engagement. The effect of online-visiting frequency and online engagement on outcome variables was investigated. Of 196 eligible participants-100 in the control group and 96 in the intervention group-who joined the study, 2 (1.0%) control participants joined the Facebook group and 24 of the remaining 194 participants (12.4%) were lost to follow-up. For the process evaluation, participants in the intervention group reported more satisfying online experiences (Psocial media-delivered, safer sex intervention was found to be feasible and effective in improving attitudes toward condom use and behavioral skills, but was not significantly more effective than a website. Future research may focus on the long-term effectiveness and cost-effectiveness of this popular method, as well as the potential cultural differences of using social media between different countries. Chinese Clinical Trial Registry (ChiCTR): ChiCTR-IOR-16009495; http

Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

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Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

2017-09-15

Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

Effect of educational intervention program for parents on adolescents'nutritional behaviors in Isfahan in 2016.

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Mokhtari, Fatemeh; Kazemi, Ashraf; Ehsanpour, Soheila

2017-01-01

Family participation is an important element on nutritional education especially for students. Parents have a key role in instilling and understanding healthy eating habits, but yet the use of family participation strategies in the nutrition education was low. The aim of this study is determining the effect of parental educational intervention program for parents on adolescents' nutritional behaviors in Isfahan, Iran in 2016. This study was a kind of field trial that conducted on 63 girl teenagers from junior high schools of Isfahan in 2016 that were randomly divided into two groups of intervention and control. The data collection tool which was a researcher made questionnaire was completed in both groups before and 1 month after the intervention. The intervention included three training sessions for parents and giving educational compact disc and forwarding SMS. To analysis of data independent t -test and paired t -test were used. Paired t -test showed that in intervention group the average score of fruit ( P = 0.03) and in control group the average score of vegetables ( P < 0.05) were significant statistical difference, but in other aspects of nutritional behaviors was not a significant difference. Independent t -test showed that after intervention, mean scores nutritional behavior of adolescent girls in both groups had no significant differences. No significant difference was in the nutritional behaviors before and after the intervention. Hence, just educating the parents is not enough for achieving appropriate nutritional behaviors in the adolescents.

Dialectical behavior therapy for adolescents with repeated suicidal and self-harming behavior: a randomized trial.

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Mehlum, Lars; Tørmoen, Anita J; Ramberg, Maria; Haga, Egil; Diep, Lien M; Laberg, Stine; Larsson, Bo S; Stanley, Barbara H; Miller, Alec L; Sund, Anne M; Grøholt, Berit

2014-10-01

We examined whether a shortened form of dialectical behavior therapy, dialectical behavior therapy for adolescents (DBT-A) is more effective than enhanced usual care (EUC) to reduce self-harm in adolescents. This was a randomized study of 77 adolescents with recent and repetitive self-harm treated at community child and adolescent psychiatric outpatient clinics who were randomly allocated to either DBT-A or EUC. Assessments of self-harm, suicidal ideation, depression, hopelessness, and symptoms of borderline personality disorder were made at baseline and after 9, 15, and 19 weeks (end of trial period), and frequency of hospitalizations and emergency department visits over the trial period were recorded. Treatment retention was generally good in both treatment conditions, and the use of emergency services was low. DBT-A was superior to EUC in reducing self-harm, suicidal ideation, and depressive symptoms. Effect sizes were large for treatment outcomes in patients who received DBT-A, whereas effect sizes were small for outcomes in patients receiving EUC. Total number of treatment contacts was found to be a partial mediator of the association between treatment and changes in the severity of suicidal ideation, whereas no mediation effects were found on the other outcomes or for total treatment time. DBT-A may be an effective intervention to reduce self-harm, suicidal ideation, and depression in adolescents with repetitive self-harming behavior. Clinical trial registration information-Treatment for Adolescents With Deliberate Self Harm; http://ClinicalTrials.gov/; NCT00675129. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Evaluation of a Theory-Based Intervention Aimed at Reducing Intention to Use Restrictive Dietary Behaviors Among Adolescent Female Athletes.

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Laramée, Catherine; Drapeau, Vicky; Valois, Pierre; Goulet, Claude; Jacob, Raphaëlle; Provencher, Véronique; Lamarche, Benoît

2017-06-01

To evaluate the effectiveness of a theory-based intervention to reduce the intention to use restrictive dietary behaviors for losing weight among adolescent female athletes involved in aesthetic sports. Cluster-randomized controlled trial. Aesthetic sport teams of adolescent female athletes aged 12-17 years. Two teams (n = 37 athletes) in the intervention group and 3 teams (n = 33) in the comparison group. The 2 groups received nutrition education during 3 weekly 60-minute sessions. The intervention group was further exposed to a theory-based intervention targeting the specific determinant of intention to use restrictive dietary behaviors for losing weight, namely attitude. Difference over time between groups in intention to use restrictive dietary behaviors for losing weight and in nutrition knowledge. Mixed models for repeated measures. The theory-based intervention contributed to maintaining a low intention of using restrictive dietary behaviors for losing weight over time in the intervention group compared with the comparison group (P theory-based behavior change intervention may help maintain a low intention of using restrictive dietary behaviors for losing weight among female high school athletes involved in aesthetic sports. Copyright © 2017. Published by Elsevier Inc.

A computer-assisted motivational social network intervention to reduce alcohol, drug and HIV risk behaviors among Housing First residents.

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Kennedy, David P; Hunter, Sarah B; Chan Osilla, Karen; Maksabedian, Ervant; Golinelli, Daniela; Tucker, Joan S

2016-03-15

Individuals transitioning from homelessness to housing face challenges to reducing alcohol, drug and HIV risk behaviors. To aid in this transition, this study developed and will test a computer-assisted intervention that delivers personalized social network feedback by an intervention facilitator trained in motivational interviewing (MI). The intervention goal is to enhance motivation to reduce high risk alcohol and other drug (AOD) use and reduce HIV risk behaviors. In this Stage 1b pilot trial, 60 individuals that are transitioning from homelessness to housing will be randomly assigned to the intervention or control condition. The intervention condition consists of four biweekly social network sessions conducted using MI. AOD use and HIV risk behaviors will be monitored prior to and immediately following the intervention and compared to control participants' behaviors to explore whether the intervention was associated with any systematic changes in AOD use or HIV risk behaviors. Social network health interventions are an innovative approach for reducing future AOD use and HIV risk problems, but little is known about their feasibility, acceptability, and efficacy. The current study develops and pilot-tests a computer-assisted intervention that incorporates social network visualizations and MI techniques to reduce high risk AOD use and HIV behaviors among the formerly homeless. CLINICALTRIALS. NCT02140359.

Choosing a control intervention for a randomised clinical trial

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Djulbegovic Benjamin

2003-04-01

Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

A systematic review of eHealth behavioral interventions targeting smoking, nutrition, alcohol, physical activity and/or obesity for young adults

NARCIS (Netherlands)

Oosterveen, Emilie; Tzelepis, Flora; Ashton, Lee; Hutchesson, Melinda J.

2017-01-01

A systematic review of randomized control trials (RCT) was undertaken to evaluate the effectiveness of eHealth behavioral interventions aiming to improve smoking rates, nutrition behaviors, alcohol intake, physical activity levels and/or obesity (SNAPO) in young adults. Seven electronic databases

School-based intervention for childhood disruptive behavior in disadvantaged settings: A school-based RCT with and without active teacher support.

NARCIS (Netherlands)

Liber, J.M.; de Boo, G.M.; Huizenga, H.; Prins, P.J.M.

2013-01-01

Objective: In this randomized controlled trial, we investigated the effectiveness of a school-based targeted intervention program for disruptive behavior. A child-focused cognitive behavioral therapy (CBT) program was introduced at schools in disadvantaged settings and with active teacher support

Mobile technology boosts the effectiveness of psychotherapy and behavioral interventions: a meta-analysis.

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Lindhiem, Oliver; Bennett, Charles B; Rosen, Dana; Silk, Jennifer

2015-11-01

We conducted a meta-analysis on the effects of mobile technology on treatment outcome for psychotherapy and other behavioral interventions. Our search of the literature resulted in 26 empirical articles describing 25 clinical trials testing the benefits of smartphone applications, personal digital assistants (PDAs), or text messaging systems either to supplement treatment or substitute for direct contact with a clinician. Overall, mobile technology use was associated with superior treatment outcome across all study designs and control conditions, effect size (ES) = .34, p mobile technology using a rigorous "Treatment" versus "Treatment + Mobile" design, effect sizes were only slightly more modest (ES = .27) and still significant (p mobile technology for the delivery of psychotherapy and other behavioral interventions. © The Author(s) 2015.

Effectiveness of Non-pharmacological Interventions on Stereotyped and Repetitive Behaviors in Preschool Children With Autism: A Systematic Review

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Hadi Zarafshan

2017-03-01

Full Text Available Objective: The present study aimed to review the literature on non-pharmacological interventions used to treat stereotyped and repetitive behaviors by a systematic method. Methods: Two authors independently performed a search strategy on Medline/PubMed, Scopus and PsycINFO on English articles published up to April 23, 2014 with relevant search keywords. We also reviewed the bibliographies of retrieved articles and conference proceedings to obtain additional citations and references. We used those articles that address any non-pharmacological interventions on reducing stereotyped and repetitive behaviors in preschool children with autism. Four independent reviewers screened relevant articles for inclusion criteria and assessed the quality of eligible articles with CONSORT checklist. Results: In our search, 664 relevant articles were found. After removing duplicates and screening based on title, abstract, and full text, 15 high quality studies were finally included in data analyses. The included articles were published from 1987 to 2013. Three studies were designed as A-B, two as A-B-A and reminders as A-B-A-B. The data and results of 3 clinical trials were synthesized; two of them were parallel randomized clinical trial and another one was designed as cross-over. Interventions were completely heterogeneous in case studies, including non-contingent auditory stimulation, response interruption and redirection, teaching the children to request assistance on the difficult tasks, family-implemented treatment for behavioral inflexibility with treatment approach, vocal or motor response interruption and redirection, brushing, water mist treatment, exposure response prevention, tangible reinforcement or social reinforcement, and music. Interventions in clinical trials included touch therapy, kata techniques training program, and aerobic exercise. Conclusions: The results of our review indicate that different kinds of non-pharmacological interventions can

Intervention effects on safety compliance and citizenship behaviors: Evidence from the Work, Family, and Health Study.

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Hammer, Leslie B; Johnson, Ryan C; Crain, Tori L; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly D; Kelly, Erin L; Buxton, Orfeu M; Karuntzos, Georgia; Chosewood, L Casey; Berkman, Lisa

2016-02-01

We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 health care facilities using a group-randomized trial. Based on conservation of resources theory and the work-home resources model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family, and employee control over work time, would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline and at 6-month and 12-month postintervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month, and organizational citizenship behaviors at the 12-month, follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors compared with employees in the control facilities. The hypothesized mediators of perceptions of family-supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family-supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. (c) 2016 APA, all rights reserved).

Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial.

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Gao, Xiaoli; Lo, Edward Chin Man; McGrath, Colman; Ho, Samuel Mun Yin

2013-04-30

Dental caries (tooth decay) is highly prevalent and is largely attributable to unhealthy self-care behaviors (diet and oral hygiene). The conventional (health) education (CE), focusing on disseminating information and giving normative advice, often fails to achieve sustained behavioral changes. This study incorporates two innovative elements into CE: (i) motivational interviewing (MI), a client-centered counseling for changing behaviors, and (ii) an interactive caries risk assessment (RA) tool, which is devised to facilitate dental counseling and may enhance MI in several ways. Through a randomized, controlled, evaluator-blinded trial, three intervention schemes (CE, CE+MI, and CE+MI+RA) will be compared for their effectiveness in eliciting dentally healthy behaviors and preventing caries in preschool children. This study targets 3-year-old children who are at a critical stage for embedding health habits. Children with unfavorable dental behaviors (insufficient toothbrushing and/or frequent snacking) and their parents will be recruited from 12 participating kindergartens. Parent-child dyads (n=690) will be randomly assigned into three groups. In the first group (CE), oral health information and advice will be delivered to parents through pamphlets. In the second group (CE+MI), in addition to the pamphlets, individual MI counseling with each parent will be performed by one of two trained dental hygienists. In the third group (CE+MI+RA), besides pamphlets and MI, interactive RA will be integrated into MI to motivate parents and facilitate their informed decision making and goal planning. At baseline and after 12 and 24 months, parents will complete a questionnaire and children will undergo a dental examination. The effectiveness of the intervention schemes will be compared over 12 and 24 months. The primary outcome will be caries increment in children and proportion of caries-free children. Secondary outcomes will be changes in parental efficacy for protecting

Motivational interviewing in a Web-based physical activity intervention with an avatar: randomized controlled trial.

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Friederichs, Stijn; Bolman, Catherine; Oenema, Anke; Guyaux, Janneke; Lechner, Lilian

2014-02-13

Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based. The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based. A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention. Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta(AVATARvsCONTROL)=.39, P=.011; beta(TEXTvsCONTROL)=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone. The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user's state and input. Dutch Trial

A community intervention trial of multimodal suicide prevention program in Japan: a novel multimodal community intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J.

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Ono, Yutaka; Awata, Shuichi; Iida, Hideharu; Ishida, Yasushi; Ishizuka, Naoki; Iwasa, Hiroto; Kamei, Yuichi; Motohashi, Yutaka; Nakagawa, Atsuo; Nakamura, Jun; Nishi, Nobuyuki; Otsuka, Kotaro; Oyama, Hirofumi; Sakai, Akio; Sakai, Hironori; Suzuki, Yuriko; Tajima, Miyuki; Tanaka, Eriko; Uda, Hidenori; Yonemoto, Naohiro; Yotsumoto, Toshihiko; Watanabe, Naoki

2008-09-15

To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP) have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. This study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals). The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000000460.

Breakingtheice: A protocol for a randomised controlled trial of an internet-based intervention addressing amphetamine-type stimulant use

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Tait Robert J

2012-06-01

Full Text Available Abstract Background The prevalence of amphetamine-type stimulant use is greater than that of opioids and cocaine combined. Currently, there are no approved pharmacotherapy treatments for amphetamine-type stimulant problems, but some face-to-face psychotherapies are of demonstrated effectiveness. However, most treatment services focus on alcohol or opioid disorders, have limited reach and may not appeal to users of amphetamine-type stimulants. Internet interventions have proven to be effective for some substance use problems but none has specifically targeted users of amphetamine-type stimulants. Design/method The study will use a randomized controlled trial design to evaluate the effect of an internet intervention for amphetamine-type stimulant problems compared with a waitlist control group. The primary outcome will be assessed as amphetamine-type stimulant use (baseline, 3 and 6 months. Other outcomes measures will include ‘readiness to change’, quality of life, psychological distress (K-10 score, days out of role, poly-drug use, help-seeking intention and help-seeking behavior. The intervention consists of three modules requiring an estimated total completion time of 90 minutes. The content of the modules was adapted from face-to-face clinical techniques based on cognitive behavior therapy and motivation enhancement. The target sample is 160 men and women aged 18 and over who have used amphetamine-type stimulants in the last 3 months. Discussion To our knowledge this will be the first randomized controlled trial of an internet intervention specifically developed for users of amphetamine-type stimulants. If successful, the intervention will offer greater reach than conventional therapies and may engage clients who do not generally seek treatment from existing service providers. Trial registration Australian and New Zealand Clinical Trials Registry (http://www.anzctr.org.au/ ACTRN12611000947909

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

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Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Simulations for designing and interpreting intervention trials in infectious diseases.

Science.gov (United States)

Halloran, M Elizabeth; Auranen, Kari; Baird, Sarah; Basta, Nicole E; Bellan, Steven E; Brookmeyer, Ron; Cooper, Ben S; DeGruttola, Victor; Hughes, James P; Lessler, Justin; Lofgren, Eric T; Longini, Ira M; Onnela, Jukka-Pekka; Özler, Berk; Seage, George R; Smith, Thomas A; Vespignani, Alessandro; Vynnycky, Emilia; Lipsitch, Marc

2017-12-29

Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.

Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial

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Rozental, Alexander

2013-01-01

Background Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. Objective The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Methods Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment

Theoretical approaches of online social network interventions and implications for behavioral change: a systematic review.

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Arguel, Amaël; Perez-Concha, Oscar; Li, Simon Y W; Lau, Annie Y S

2018-02-01

The aim of this review was to identify general theoretical frameworks used in online social network interventions for behavioral change. To address this research question, a PRISMA-compliant systematic review was conducted. A systematic review (PROSPERO registration number CRD42014007555) was conducted using 3 electronic databases (PsycINFO, Pubmed, and Embase). Four reviewers screened 1788 abstracts. 15 studies were selected according to the eligibility criteria. Randomized controlled trials and controlled studies were assessed using Cochrane Collaboration's "risk-of-bias" tool, and narrative synthesis. Five eligible articles used the social cognitive theory as a framework to develop interventions targeting behavioral change. Other theoretical frameworks were related to the dynamics of social networks, intention models, and community engagement theories. Only one of the studies selected in the review mentioned a well-known theory from the field of health psychology. Conclusions were that guidelines are lacking in the design of online social network interventions for behavioral change. Existing theories and models from health psychology that are traditionally used for in situ behavioral change should be considered when designing online social network interventions in a health care setting. © 2016 John Wiley & Sons, Ltd.

Translating models of antisocial behavioral development into efficacious intervention policy to prevent adolescent violence.

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Dodge, Kenneth A; McCourt, Sandra N

2010-04-01

Adolescent chronic antisocial behavior is costly but concentrated in a relatively small number of individuals. The search for effective preventive interventions draws from empirical findings of three kinds of gene-by-environment interactions: (1) parenting behaviors mute the impact of genes; (2) genes alter the impact of traumatic environmental experiences such as physical abuse and peer social rejection; and (3) individuals and environments influence each other in a dynamic developmental cascade. Thus, environmental interventions that focus on high-risk youth may prove effective. The Fast Track intervention and randomized controlled trial are described. The intervention is a 10-year series of efforts to produce proximal change in parenting, peer relations, social cognition, and academic performance in order to lead to distal prevention of adolescent conduct disorder. Findings indicate that conduct disorder cases can be prevented, but only in the highest risk group of children. Implications for policy are discussed. (c) 2010 Wiley Periodicals, Inc.

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research

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Keegan Natalie

2009-09-01

Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088

An intervention to reduce sitting and increase light-intensity physical activity at work: Design and rationale of the 'Stand & Move at Work' group randomized trial.

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Buman, Matthew P; Mullane, Sarah L; Toledo, Meynard J; Rydell, Sarah A; Gaesser, Glenn A; Crespo, Noe C; Hannan, Peter; Feltes, Linda; Vuong, Brenna; Pereira, Mark A

2017-02-01

American workers spend 70-80% of their time at work being sedentary. Traditional approaches to increase moderate-vigorous physical activity (MVPA) may be perceived to be harmful to productivity. Approaches that target reductions in sedentary behavior and/or increases in standing or light-intensity physical activity [LPA] may not interfere with productivity and may be more feasible to achieve through small changes accumulated throughout the workday METHODS/DESIGN: This group randomized trial (i.e., cluster randomized trial) will test the relative efficacy of two sedentary behavior focused interventions in 24 worksites across two states (N=720 workers). The MOVE+ intervention is a multilevel individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace. The STAND+ intervention is the MOVE+ intervention with the addition of the installation and use of sit-stand workstations to reduce sedentary behavior and enhance light-intensity physical activity opportunities. Our primary outcome will be objectively-measured changes in sedentary behavior and light-intensity physical activity over 12months, with additional process measures at 3months and longer-term sustainability outcomes at 24months. Our secondary outcomes will be a clustered cardiometabolic risk score (comprised of fasting glucose, insulin, triglycerides, HDL-cholesterol, and blood pressure), workplace productivity, and job satisfaction DISCUSSION: This study will determine the efficacy of a multi-level workplace intervention (including the use of a sit-stand workstation) to reduce sedentary behavior and increase LPA and concomitant impact on cardiometabolic health, workplace productivity, and satisfaction. ClinicalTrials.gov Identifier: NCT02566317 (date of registration: 10/1/2015). Copyright © 2016 Elsevier Inc. All rights reserved.

"Straight Talk" for African-American heterosexual men: results of a single-arm behavioral intervention trial.

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Frye, Victoria; Henny, Kirk; Bonner, Sebastian; Williams, Kim; Bond, Keosha T; Hoover, Donald R; Lucy, Debbie; Greene, Emily; Koblin, Beryl A

2013-01-01

In the United States, heterosexual transmission is the second leading cause of HIV/AIDS, and two-thirds of all heterosexually acquired cases diagnosed between 2005 and 2008 occurred among African-Americans. Few HIV prevention interventions have been designed specifically for African-American heterosexual men not seeking clinical treatment. Here we report results of a single-arm intervention trial of a theory-based HIV prevention intervention designed to increase condom use, reduce concurrent partnering and increase HIV testing among heterosexually active African-American men living in high HIV prevalence areas of New York City. We tested our hypothesis using McNemar discordant pairs exact test for binary variables and paired t-tests for continuous variables. We observed statistically significant declines in mean number of total and new female partners, unprotected sex partners, and partner concurrency in both primary and nonprimary sex partnerships between baseline and 3 months postintervention.

The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial.

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Clare, Linda; Hindle, John V; Jones, Ian R; Thom, Jeanette M; Nelis, Sharon M; Hounsome, Barry; Whitaker, Christopher J

2012-07-24

Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75) will be randomized to one of three conditions: control (an interview involving a general discussion about the center); goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement); or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring). All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life), cognitive (memory and executive function), and physical fitness (functional and metabolic) domains. Cost-effectiveness will also be examined. This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com).

The Child and Adolescent Trial for Cardiovascular Health (CATCH): intervention, implementation, and feasibility for elementary schools in the United States.

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Perry, C L; Sellers, D E; Johnson, C; Pedersen, S; Bachman, K J; Parcel, G S; Stone, E J; Luepker, R V; Wu, M; Nader, P R; Cook, K

1997-12-01

The Child and Adolescent Trial for Cardiovascular Health (CATCH) was the largest school-based field trial ever sponsored by the National Institutes of Health. The trial demonstrated positive changes in the school food service and physical education program, as well as in students' cardiovascular health behaviors. Because the CATCH intervention programs were implemented in 56 schools (in four states) that were typical of schools throughout the United States, their reception by schools and degree of implementation provide evidence about their feasibility for schools nationally. Extensive process evaluation data were collected from students, teachers, school food service personnel, and physical education specialists throughout the three school years of the CATCH intervention. Four of the CATCH programs--school food service, physical education, classroom curricula, and home programs--were assessed over the three school years. The process data provide information on participation, dose, fidelity, and compatibility of the CATCH programs in the intervention schools for these programs. High levels of participation, dose, fidelity, and compatibility were observed for the four programs during the 3 school years. CATCH emerges as a model of a feasible multilevel health promotion program to improve eating and exercise behaviors for elementary schools in the United States.

Development of an evidence-based, gay-specific cognitive behavioral therapy intervention for methamphetamine-abusing gay and bisexual men.

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Reback, Cathy J; Shoptaw, Steven

2014-08-01

This study compared outcomes in methamphetamine use and sexual risk behaviors from a modified gay-specific, cognitive behavioral therapy (GCBT) combined with a low-cost contingency management (CM; [GCBT+CM]) intervention to prior findings from clinical trials of the original GCBT. Effect sizes for primary outcomes were compared using meta analysis. Comparisons of effect sizes at end of treatment showed the modified GCBT+CM produced significantly fewer consecutive weeks of methamphetamine abstinence (-0.44, CI: -0.79, -0.09) and fewer male sexual partners (-0.36, CI: -0.71, -0.02) than the first trial of GCBT, and more days of methamphetamine use (0.35, CI: 0.02, 0.68) than the second trial of GCBT. At 26-week follow-up, the modified GCBT+CM produced greater effects in reducing the number of male sexual partners (-0.54, CI: -0.89, -0.19; -0.51, CI: -0.84, -0.18). The original GCBT produced more and mostly short-term beneficial drug use outcomes, though sexual behavior changes consistently favored the modified GCBT+CM. On balance, most benefits are retained with the modified GCBT+CM intervention. Copyright © 2011 Elsevier Ltd. All rights reserved.

Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

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Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

2015-01-01

Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

Science.gov (United States)

Lindenberg, Katajun; Halasy, Katharina; Schoenmaekers, Sophie

2017-06-01

The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention programs. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT group intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, are randomly assigned to a) PROTECT preventive intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms as well as the promotion of problem solving, cognitive restructuring and emotion regulation skills. The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention, i.e., it is theory- and evidence-based and addresses both risk-reduction and strength-promotion, it considers current research and epidemiology and ethical standards such as professional secrecy and is designed as a systemic intervention at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate). ClinicalTrials.gov: NCT02907658.

Childhood obesity prevention interventions in childcare settings: systematic review of randomized and nonrandomized controlled trials.

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Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C

2014-01-01

Childcare settings are an opportune location for early intervention programs seeking to prevent childhood obesity. This article reports on a systematic review of controlled trials of obesity prevention interventions in childcare settings. The review was limited to English language articles published in PubMed, Web of Science, and Education Resources Information Center (ERIC) between January 2000 and April 2012. childhood obesity prevention interventions in childcare settings using controlled designs that reported adiposity and behavior outcomes. no interventions, non-childcare settings, clinical weight loss programs, non-English publications. Publications were identified by key word search. Two authors reviewed eligible studies to extract study information and study results. Qualitative synthesis was conducted, including tabulation of information and a narrative summary. Fifteen studies met the eligibility criteria. Seven studies reported improvements in adiposity. Six of the 13 interventions with dietary components reported improved intake or eating behaviors. Eight of the 12 interventions with physical activity components reported improved activity levels or physical fitness. Evidence was mixed for all outcomes. Results should be interpreted cautiously given the high variability in study designs and interventions. Further research needs long-term follow-up, multistrategy interventions that include changes in the nutrition and physical activity environment, reporting of cost data, and consideration of sustainability.

Long-term dietary intervention trials: critical issues and challenges

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Crichton Georgina E

2012-07-01

Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347

Testing the efficacy of a brief sexual risk reduction intervention among high-risk American Indian adults: study protocol for a randomized controlled trial

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Rachel Chambers

2016-04-01

Full Text Available Abstract Background American Indian adults are more likely to experience co-occurring mental health and substance use disorders than adults of other racial/ethnic groups and are disproportionately burdened by the most common sexually transmitted infections, namely chlamydia and gonorrhea. Several behavioral interventions are proven efficacious in lowering risk for sexually transmitted infection in various populations and, if adapted to address barriers experienced by American Indian adults who suffer from mental health and substance use problems, may be useful for dissemination in American Indian communities. The proposed study aims to examine the efficacy of an adapted evidence-based intervention to increase condom use and decrease sexual risk-taking and substance use among American Indian adults living in a reservation-based community in the Southwestern United States. Methods/Design The proposed study is a randomized controlled trial to test the efficacy of an adapted evidence-based intervention compared to a control condition. Participants will be American Indian adults ages 18–49 years old who had a recent episode of binge substance use and/or suicide ideation. Participants will be randomized to the intervention, a two-session risk-reduction counseling intervention or the control condition, optimized standard care. All participants will be offered a self-administered sexually transmitted infection test. Participants will complete assessments at baseline, 3 and 6 months follow-up. The primary outcome measure is condom use at last sex. Discussion This is one of the first randomized controlled trials to assess the efficacy of an adapted evidence-based intervention for reducing sexual risk behaviors among AI adults with substance use and mental health problems. If proven successful, there will be an efficacious program for reducing risk behaviors among high-risk adults that can be disseminated in American Indian communities as well as other

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

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Guallar Eliseo

2010-12-01

Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity

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Callahan Randi

2008-06-01

Full Text Available Abstract Background Although several previous projects have attempted to address the issue of child obesity through school-based interventions, the overall effectiveness of school-based programs on health-related outcomes in youth has been poor. Thus, it has been suggested that multi-level interventions that aim to influence healthy lifestyle behaviors at the community, school and family levels may prove more successful in the prevention of childhood obesity. Methods/Design This paper describes the rationale, design, and implementation of a community-, school-, and family-based intervention aimed at modifying key behaviors (physical activity, screen time (Internet, television, video games, and nutrition related to childhood obesity among third through fifth graders in two mid-western cities. The intervention involves a randomized study of 10 schools (5 intervention and 5 control schools. The intervention is being conducted during the duration of the academic year – approximately 9 months – and includes baseline and post-intervention measurements of physical activity, dietary intake, screen time and body composition. Discussion We hope this report will be useful to researchers, public health professionals, and school administrators and health professionals (nurses and physical/health educators seeking to develop similar prevention programs. It is obvious that more collaborative, inter-disciplinary, multi-level work is needed before a proven, effective intervention package to modify behaviors related to childhood obesity can be generally recommended. It is our hope that SWITCH is a step in that direction. Trial Registration ClinicalTrials.gov NCT00685555

Theory, evidence and Intervention Mapping to improve behavior nutrition and physical activity interventions.

OpenAIRE

Brug, Hans; Oenema, Anke; Ferreira, Isabel

2005-01-01

Abstract Background The present paper intends to contribute to the debate on the usefulness and barriers in applying theories in diet and physical activity behavior-change interventions. Discussion Since behavior theory is a reflection of the compiled evidence of behavior research, theory is the only foothold we have for the development of behavioral nutrition and physical activity interventions. Application of theory should improve the effectiveness of interventions. However, some of the the...

A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer.

Science.gov (United States)

Robb, Sheri L; Clair, Alicia A; Watanabe, Masayo; Monahan, Patrick O; Azzouz, Faouzi; Stouffer, Janice W; Ebberts, Allison; Darsie, Emily; Whitmer, Courtney; Walker, Joey; Nelson, Kirsten; Hanson-Abromeit, Deanna; Lane, Deforia; Hannan, Ann

2008-07-01

Coping theorists argue that environmental factors affect how children perceive and respond to stressful events such as cancer. However, few studies have investigated how particular interventions can change coping behaviors. The active music engagement (AME) intervention was designed to counter stressful qualities of the in-patient hospital environment by introducing three forms of environmental support. The purpose of this multi-site randomized controlled trial was to determine the efficacy of the AME intervention on three coping-related behaviors (i.e. positive facial affect, active engagement, and initiation). Eighty-three participants, ages 4-7, were randomly assigned to one of three conditions: AME (n = 27), music listening (ML; n = 28), or audio storybooks (ASB; n = 28). Conditions were videotaped to facilitate behavioral data collection using time-sampling procedures. After adjusting for baseline differences, repeated measure analyses indicated that AME participants had a significantly higher frequency of coping-related behaviors compared with ML or ASB. Positive facial affect and active engagement were significantly higher during AME compared with ML and ASB (p<0.0001). Initiation was significantly higher during AME than ASB (p<0.05). This study supports the use of the AME intervention to encourage coping-related behaviors in hospitalized children aged 4-7 receiving cancer treatment. (c) 2007 John Wiley & Sons, Ltd.

“Evaluation of a peer network intervention trial among young methamphetamine users in Chiang Mai, Thailand”

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Sutcliffe, Catherine; Srirojn, Bangorn; Latkin, Carl A; Aramratanna, Ajpinun; Sherman, Susan G

2009-01-01

Since the 1990s, there has been a proliferation of methamphetamine use in Thailand, particularly among young people. Simultaneously, risky sexual behaviors among this population have increased. This study examined the effects of a peer network intervention and a life skills intervention on methamphetamine and HIV risk behaviors among 18–25 year olds in Chiang Mai, Thailand. Between April 2005 and June 2007, we conducted a randomized behavioral trial to compare the efficacy of a peer educator, network-oriented intervention with a best practice, life-skills curriculum on methamphetamine use, sexual behaviors, and incident sexually transmitted infections (STIs). Follow-up occurred at three, six, nine, and twelve months. Both conditions consisted of seven, two hour, small group sessions. Longitudinal analyses of the three outcomes were conducted by fitting repeated measures logistic regression models using generalized estimating equations. Participants (N=983) attended a median of six sessions, with no differences between arms. At each follow-up visit, retention was greater than 85%. Participants were 75% male and were a median of 19 years old. Over time, participants in both conditions showed a significant and dramatic decline in self-reported methamphetamine use (99% at baseline versus 53% at 12-months, p<0.0001) and significant increase in consistent condom use (32% baseline versus 44% at 12 months, p<0.0001). Incident STIs were common, with no differences between arms. Chlamydia had the highest incidence rate, 9.85/100 person-years and HIV had a low incidence rate of 0.71/100 person-years. Among young Thais, we found that a peer educator, network-oriented intervention was associated with reductions in methamphetamine use, increases in condom use, and reductions in incident STIs over 12 months. We also found parallel reductions with the life skills condition. To our knowledge, this is the first such trial targeting this population. Small group interventions are an

The Treatment of Recurrent Abdominal Pain in Children: A Controlled Comparison of Cognitive-Behavioral Family Intervention and Standard Pediatric Care.

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Sanders, Matthew R.; And Others

1994-01-01

Conducted controlled clinical trial involving 44 children with recurrent abdominal pain randomly assigned to cognitive-behavioral family intervention (CBFI) or standard pediatric care (SPC). Both treatments resulted in significant improvements on measures of pain intensity and pain behavior. CBFI group had higher rate of complete elimination of…

Towards Behaviorally Informed Public Interventions

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Karol Olejniczak

2015-06-01

Full Text Available Purpose: This article informs readers about the theoretical and practical origins of the behaviorally informed interventions (BIPI, analyzes examples of the BIPI from different policy sectors and strategies they offer for policy and regulatory design, and discusses applications and implications of BIPI for public interventions Methodology: This paper is based on a review of literature, as well as an inspection of administrative practices in OECD countries. It encompasses a systematic analysis of scientific papers fromthe SCOPUS database and a query carried out at the library of George Washington University. Findings: The traditional approach to public policy research is based on rational choice theory. It offers limited support, because by assuming perfect rationality of policy decisions, it overlooks existence of systematic errors and biases of human decision-making. The authors argue that behaviorally informed public interventions (BIPI might contribute to improving the effectiveness of a number of public measures – regulation, projects, programs, and even entire policies. Practical implications: The behavioral approach allows decision-makers to better understand the decisions and behaviors of citizens, as well as to design more effective interventions with minimum effort by adapting the existing solutions to real decision mechanisms of citizens. Originality: By combining the concepts of traditional approach with the growing behavioral approach, the authors aim to propose a new theoretical framework (BIPI to be used as a tool for policy design, delivery and evaluation.

Theory, evidence and Intervention Mapping to improve behavior nutrition and physical activity interventions

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Ferreira Isabel

2005-04-01

Full Text Available Abstract Background The present paper intends to contribute to the debate on the usefulness and barriers in applying theories in diet and physical activity behavior-change interventions. Discussion Since behavior theory is a reflection of the compiled evidence of behavior research, theory is the only foothold we have for the development of behavioral nutrition and physical activity interventions. Application of theory should improve the effectiveness of interventions. However, some of the theories we use lack a strong empirical foundation, and the available theories are not always used in the most effective way. Furthermore, many of the commonly-used theories provide at best information on what needs to be changed to promote healthy behavior, but not on how changes can be induced. Finally, many theories explain behavioral intentions or motivation rather well, but are less well-suited to explaining or predicting actual behavior or behavior change. For more effective interventions, behavior change theory needs to be further developed in stronger research designs and such change-theory should especially focus on how to promote action rather than mere motivation. Since voluntary behavior change requires motivation, ability as well as the opportunity to change, further development of behavior change theory should incorporate environmental change strategies. Conclusion Intervention Mapping may help to further improve the application of theories in nutrition and physical activity behavior change.

Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

Science.gov (United States)

Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

2016-12-01

To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

Using a social story intervention to decrease inappropriate behavior of preschool children with autism

Directory of Open Access Journals (Sweden)

Angkhana Khantreejitranon

2018-01-01

Full Text Available This research investigated the inappropriate behavior of preschool children with autism in a classroom and examined the effectiveness of the use of social stories to decrease inappropriate autistic behavior. An A-B-A-B single subject design was used across the five participants selected for the study. Investigating the problematic social skills and developing a social story intervention for the preschool autistic children was completed, followed by an examination of the effectiveness of the social story intervention. Ten common problematic social skills among the autistic children in preschool were identified—walking around, making loud noises, not sharing their toys with others, showing frustration when feeling unsatisfied, having no patience, not putting toys away when finished, taking other people's belongings without permission, not knowing how to greet others, destroying things when feeling frustrated, and giving a hug to other people at inappropriate times. It was found that the social story intervention helped to decrease inappropriate behavior in children with autism. The social story intervention consisted of five social story books and five e-books (one story per child using a single subject design with an A-B-A-B pattern. The autistic children preferred social stories from the hardcopy books compared with stories from the e-books. A fourth stage time trial was used over 6 weeks, five times per week, for a total of 30 times. The findings suggested that the use of properly constructed social stories can be effective in decreasing the inappropriate behavior of children with autism. However, each story intervention should be applied with caution because of individual differences between children. The social story intervention should be designed only for autistic children who exhibit specific inappropriate social behavior. Keywords: autistic child, inappropriate behavior, social skills, social story

A cognitive/behavioral group intervention for weight loss in patients treated with atypical antipsychotics.

Science.gov (United States)

Weber, Mary; Wyne, Kathleen

2006-03-01

Obesity and diabetes have caused problems for individuals with schizophrenia long before atypical antipsychotic agents. The prevalence of obesity, insulin resistance, impaired glucose tolerance, type 2 diabetes mellitus, dyslipidemia, and the Metabolic Syndrome has increased in people with schizophrenia as compared to the general population. Risk reduction studies for persons with obesity, diabetes, and cardiovascular disease indicate that cognitive/behavioral interventions that promote motivation and provide strategies to overcome the barriers in adherence to diet and activity modification are effective interventions for weight management and risk reduction. In the landmark multi-center randomized-controlled trial study, the Diabetes Prevention Project (DPP), a cognitive/behavioral intervention, was more successful in producing weight loss and preventing diabetes than the drugs metformin, troglitazone or placebo. This pilot study examined the effectiveness of a cognitive/behavioral group intervention, modified after the DPP program, in individuals with schizophrenia or schizoaffective disorder taking atypical antipsychotics in a large urban public mental health system. Outcome measures included body weight, body mass index, waist-hip ratios, and fasting glucose levels. Both groups demonstrated elevated fasting glucose levels and were obese with a mean BMI of 33. The group that received the cognitive/behavioral group intervention lost more weight than the treatment as usual group. The CB group participants lost an average of 5.4 lb or 2.9% of body weight, and those in the control group lost 1.3 lb or 0.6% body weight. The range of weight loss for the treatment group was from 1 to 20 lb. This pilot study has demonstrated that weight loss is possible with cognitive/behavioral interventions in a population with a psychotic disorder.

Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster randomized pragmatic trial

Science.gov (United States)

Choudhry, Niteesh K.; Isaac, Thomas; Lauffenburger, Julie C.; Gopalakrishnan, Chandrasekar; Khan, Nazleen F.; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L.; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M.; Naseem, Samrah; Gagne, Joshua J.; Jackevicius, Cynthia A.; Fischer, Michael A.; Solomon, Daniel H.; Sequist, Thomas D.

2016-01-01

Background Approximately half of patients with chronic cardiometabolic conditions are non-adherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may or may not need adherence assistance. Objective To evaluate the effect of a multi-component, behaviorally-tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. Trial design The STIC2IT (Study of a Tele-pharmacy Intervention for Chronic diseases To Improve Treatment adherence) trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multi-component intervention that uses behavioral interviewing, text messaging, mailed progress reports and video visits. Targeted patients are those who are non-adherent to glucose-lowering, anti-hypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients’ individual health barriers and their level of health activation. We cluster randomized 14 practice sites of a large multi-specialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients to be followed for 12 months after randomization. The trial’s primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and healthcare resource utilization. Conclusion This trial will determine whether a technologically-enabled, behaviorally-targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. PMID:27659887

A randomized controlled trial to evaluate the Make Safe Happen® app-a mobile technology-based safety behavior change intervention for increasing parents' safety knowledge and actions.

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McKenzie, Lara B; Roberts, Kristin J; Clark, Roxanne; McAdams, Rebecca; Abdel-Rasoul, Mahmoud; Klein, Elizabeth G; Keim, Sarah A; Kristel, Orie; Szymanski, Alison; Cotton, Christopher G; Shields, Wendy C

2018-03-12

Many unintentional injuries that occur in and around the home can be prevented through the use of safety equipment and by consistently following existing safety recommendations. Unfortunately, uptake of these safety behaviors is unacceptably low. This paper describes the design of the Make Safe Happen® smartphone application evaluation study, which aims to evaluate a mobile technology-based safety behavior change intervention on parents' safety knowledge and actions. Make Safe Happen® app evaluation study is a randomized controlled trial. Participants will be parents of children aged 0-12 years who are recruited from national consumer online survey panels. Parents will complete a pretest survey, and will be randomized to receive the Make Safe Happen® app or a non-injury-related app, and then complete a posttest follow-up survey after 1 week. Primary outcomes are: (1) safety knowledge; (2) safety behaviors; (3) safety device acquisition and use, and (4) behavioral intention to take safety actions. Anticipated study results are presented. Wide-reaching interventions, to reach substantial parent and caregiver audiences, to effectively reduce childhood injuries are needed. This study will contribute to the evidence-base about how to increase safety knowledge and actions to prevent home-related injuries in children. NCT02751203 ; Pre-results.

Testing self-regulation interventions to increase walking using factorial randomized N-of-1 trials.

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Sniehotta, Falko F; Presseau, Justin; Hobbs, Nicola; Araújo-Soares, Vera

2012-11-01

To investigate the suitability of N-of-1 randomized controlled trials (RCTs) as a means of testing the effectiveness of behavior change techniques based on self-regulation theory (goal setting and self-monitoring) for promoting walking in healthy adult volunteers. A series of N-of-1 RCTs in 10 normal and overweight adults ages 19-67 (M = 36.9 years). We randomly allocated 60 days within each individual to text message-prompted daily goal-setting and/or self-monitoring interventions in accordance with a 2 (step-count goal prompt vs. alternative goal prompt) × 2 (self-monitoring: open vs. blinded Omron-HJ-113-E pedometer) factorial design. Aggregated data were analyzed using random intercept multilevel models. Single cases were analyzed individually. The primary outcome was daily pedometer step counts over 60 days. Single-case analyses showed that 4 participants significantly increased walking: 2 on self-monitoring days and 2 on goal-setting days, compared with control days. Six participants did not benefit from the interventions. In aggregated analyses, mean step counts were higher on goal-setting days (8,499.9 vs. 7,956.3) and on self-monitoring days (8,630.3 vs. 7,825.9). Multilevel analyses showed a significant effect of the self-monitoring condition (p = .01), the goal-setting condition approached significance (p = .08), and there was a small linear increase in walking over time (p = .03). N-of-1 randomized trials are a suitable means to test behavioral interventions in individual participants.

Breakingtheice: a protocol for a randomised controlled trial of an internet-based intervention addressing amphetamine-type stimulant use.

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Tait, Robert J; McKetin, Rebecca; Kay-Lambkin, Frances; Bennett, Kylie; Tam, Ada; Bennett, Anthony; Geddes, Jenny; Garrick, Adam; Christensen, Helen; Griffiths, Kathleen M

2012-06-25

The prevalence of amphetamine-type stimulant use is greater than that of opioids and cocaine combined. Currently, there are no approved pharmacotherapy treatments for amphetamine-type stimulant problems, but some face-to-face psychotherapies are of demonstrated effectiveness. However, most treatment services focus on alcohol or opioid disorders, have limited reach and may not appeal to users of amphetamine-type stimulants. Internet interventions have proven to be effective for some substance use problems but none has specifically targeted users of amphetamine-type stimulants. The study will use a randomized controlled trial design to evaluate the effect of an internet intervention for amphetamine-type stimulant problems compared with a waitlist control group. The primary outcome will be assessed as amphetamine-type stimulant use (baseline, 3 and 6 months). Other outcomes measures will include 'readiness to change', quality of life, psychological distress (K-10 score), days out of role, poly-drug use, help-seeking intention and help-seeking behavior. The intervention consists of three modules requiring an estimated total completion time of 90 minutes. The content of the modules was adapted from face-to-face clinical techniques based on cognitive behavior therapy and motivation enhancement. The target sample is 160 men and women aged 18 and over who have used amphetamine-type stimulants in the last 3 months. To our knowledge this will be the first randomized controlled trial of an internet intervention specifically developed for users of amphetamine-type stimulants. If successful, the intervention will offer greater reach than conventional therapies and may engage clients who do not generally seek treatment from existing service providers. Australian and New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) ACTRN12611000947909.

Finding harmony so the music plays on: pragmatic trial design considerations to promote organizational sustainment of an empirically-supported behavior therapy.

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Hartzler, Bryan; Peavy, K Michelle; Jackson, T Ron; Carney, Molly

2016-01-22

Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM. Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation. Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures

An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

International Nuclear Information System (INIS)

Jeffries, Sherryl A.; Robinson, John W.; Craighead, Peter S.; Keats, Melanie R.

2006-01-01

Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Douglas Berger

2015-08-01

Full Text Available While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.

Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment.

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Röthlin, Philipp; Birrer, Daniel; Horvath, Stephan; Grosse Holtforth, Martin

2016-07-26

Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of intervention techniques, many of which are not evidence-based. Evidence-based techniques promote quality management and could help athletes, for example, to increase and maintain functional athletic behavior in competitions/games (i.e., being focused on task relevant cues and executing movements and actions in high quality). However, well-designed trials investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The planed study is founded by the Swiss National Science Foundation and examines the effectiveness of two interventions with elite and sub-elite athletes. A psychological skills training (PST) and a mindfulness-based intervention (MI), administered as group-program, will be compared to a waiting-list control group concerning how they enhance functional athletic behavior - which is a prerequisite for optimal performance. Furthermore, we will investigate underlying mechanisms (mediators) and moderators (e.g., task difficulty, individual characteristics, intervention-expectancy and intervention-integrity). The presented trial uses a randomized controlled design with three groups, comparing PST, MI and a waiting list control condition. Both group interventions will last 5 weeks, consist of four 2 h sessions and will be administered by a trained sport psychologist. Primary outcome is functional athletic behavior assessed using ambulatory assessment in a competition/game. As secondary outcomes competition anxiety, cognitive interference and negative outcome expectations will be assessed. Assessments are held at pre- and post-intervention as well as at 2 months follow up. The study has been approved by the ethical committee of the Swiss Federal Institute of Sport. Both PST and MI are expected to help improve functional behavior in athletes. By

A Systematic Review of Digital Interventions for Improving the Diet and Physical Activity Behaviors of Adolescents.

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Rose, Taylor; Barker, Mary; Maria Jacob, Chandni; Morrison, Leanne; Lawrence, Wendy; Strömmer, Sofia; Vogel, Christina; Woods-Townsend, Kathryn; Farrell, David; Inskip, Hazel; Baird, Janis

2017-12-01

Many adolescents have poor diet and physical activity behaviors, which can lead to the development of noncommunicable diseases in later life. Digital platforms offer inexpensive means of delivering health interventions, but little is known about their effectiveness. This systematic review was conducted to synthesize evidence on the effectiveness of digital interventions to improve diet quality and increase physical activity in adolescents, to effective intervention components and to assess the cost-effectiveness of these interventions. Following a systematic search, abstracts were assessed against inclusion criteria, and data extraction and quality assessment were performed for included studies. Data were analyzed to identify key features that are associated with significant improvement in behavior. A total of 27 studies met inclusion criteria. Most (n = 15) were Web site interventions. Other delivery methods were text messages, games, multicomponent interventions, emails, and social media. Significant behavior change was often seen when interventions included education, goal setting, self-monitoring, and parental involvement. None of the publications reported cost-effectiveness. Due to heterogeneity of studies, meta-analysis was not feasible.It is possible to effect significant health behavior change in adolescents through digital interventions that incorporate education, goal setting, self-monitoring, and parental involvement. Most of the evidence relates to Web sites and further research into alternate media is needed, and longer term outcomes should be evaluated. There is a paucity of data on the cost-effectiveness of digital health interventions, and future trials should report these data. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

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Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

2017-06-01

(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (psmindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (psmindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138

A randomized controlled trial of the effect of a brief cognitive-behavioral intervention on dental fear

DEFF Research Database (Denmark)

Spindler, Helle; Staugaard, Søren Risløv; Nicolaisen, Camilla

2015-01-01

The objective of this study was to examine the effect of a brief cognitive-behavioral intervention for patients with dental fear in a private dental clinic. Patients presenting with subjectively reported dental fear were randomly assigned to either an immediate intervention (n = 53) or a waiting...... list (n = 51) group. Both groups received an identical intervention, but delayed by 4-6 weeks in the waiting list group. Participants were asked to fill out two self-report questionnaires of dental fear at pre- and post-intervention, and again at a 2-year follow-up assessment. Analysis of variance...... showed that dental fear was significantly reduced in the immediate intervention group (d = 1.5-2.2), compared with the waiting list group (d = 0.3-0.4). Additionally, all participants showed a significant reduction of dental fear following the brief intervention, and in the subgroup available for follow...

Internet-based cognitive behavior therapy for procrastination: study protocol for a randomized controlled trial.

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Rozental, Alexander; Carlbring, Per

2013-11-12

Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment period, albeit without

Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial.

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Begeer, Sander; Howlin, Patricia; Hoddenbach, Elske; Clauser, Cassandra; Lindauer, Ramon; Clifford, Pamela; Gevers, Carolien; Boer, Frits; Koot, Hans M

2015-12-01

Limited perspective taking or "Theory of Mind" (ToM) abilities are a core deficit of autism, and many interventions are aimed to improve ToM abilities. In this study, we investigated the effectiveness of a ToM treatment for children with autism spectrum disorders (ASD) and, for the first time, the moderating roles of social interaction style (SIS) and disruptive behavior (DB), to determine which children are most likely to respond to this intervention. The trial protocol is registered at www.trialregister.nl, trial number 2327 and published before the data collection was finished (www.trialsjournal.com). Children with autism aged 7-12 years (n = 97) were randomized over a waitlist control or a treatment condition. Outcome measures included ToM and emotion understanding, parent and teacher questionnaires on children's social skills, ToM-related social behavior, and autistic traits. Six-month follow-up parent reported data were collected for the treatment group. The treatment had a positive effect on ToM understanding, parent-reported ToM behavior, and autistic traits, but not on parent or teacher-reported social behavior. Passive SIS was associated with diminished treatment effects on autistic traits, but DB was unrelated to outcomes. The ToM intervention improved conceptual social understanding and ToM-related behavior of children with ASD. However, broader application of learned skills to other domains of functioning was limited. Individual differences with regard to treatment response are discussed. © 2015 International Society for Autism Research, Wiley Periodicals, Inc.

Mixed methods evaluation of a randomized control pilot trial targeting sugar-sweetened beverage behaviors.

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Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul

2013-02-01

This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER), as compared to a matched-contact control intervention targeting physical activity (MoveMore). Both 5-week interventions included two interactive group sessions and three support telephone calls. Executing a patient-centered developmental process, the primary aim of this paper was to evaluate patient feedback on intervention content and structure. The secondary aim was to understand the potential reach (i.e., proportion enrolled, representativeness) and effectiveness (i.e. health behaviors, theorized mediating variables, quality of life) of SipSmartER. Twenty-five participants were randomized to SipSmartER (n=14) or MoveMore (n=11). Participants' intervention feedback was positive, ranging from 4.2-5.0 on a 5-point scale. Qualitative assessments reavealed several opportunties to improve clarity of learning materials, enhance instructions and communication, and refine research protocols. Although SSB consumption decreased more among the SipSmartER participants (-256.9 ± 622.6 kcals), there were no significant group differences when compared to control participants (-199.7 ± 404.6 kcals). Across both groups, there were significant improvements for SSB attitudes, SSB behavioral intentions, and two media literacy constructs. The value of using a patient-centered approach in the developmental phases of this intervention was apparent, and pilot findings suggest decreased SSB may be achieved through targeted health literacy and TPB strategies. Future efforts are needed to examine

Intervention induced changes on parenting practices, youth self-pride and sexual norms to reduce HIV-related behaviors among rural African American youths.

Science.gov (United States)

Murry, Velma McBride; Berkel, Cady; Chen, Yi-Fu; Brody, Gene H; Gibbons, Frederick X; Gerrard, Meg

2011-09-01

AIDS is the leading killer of African Americans between the ages of 25 and 44, many of whom became infected when they were teenagers or young adults. The disparity in HIV infection rate among African Americans youth residing in rural Southern regions of the United States suggests that there is an urgent need to identify ways to promote early preventive intervention to reduce HIV-related risk behavior. The Strong African American Families (SAAF) program, a preventive intervention for rural African American parents and their 11-year-olds, was specially designed to deter early sexual onset and the initiation and escalation of alcohol and drug use among rural African American preadolescents. A clustered-randomized prevention trial was conducted, contrasting families who took part in SAAF with control families. The trial, which included 332 families, indicated that intervention-induced changes occurred in intervention-targeted parenting, which in turn facilitated changes in youths' internal protective processes and positive sexual norms. Long-term follow up assessments when youth were 17 years old revealed that intervention-induced changes in parenting practices mediated the effect of intervention-group influences on changes in the onset and escalation of risky sexual behaviors over 65 months through its positive influence on adolescents' self-pride and their sexual norms. The findings underscore the powerful effects of parenting practices among rural African American families that over time serve a protective role in reducing youth's risk behavior, including HIV vulnerable behaviors.

Diet, physical exercise and cognitive behavioral training as a combined workplace based intervention to reduce body weight and increase physical capacity in health care workers - a randomized controlled trial

Directory of Open Access Journals (Sweden)

Holtermann Andreas

2011-08-01

Full Text Available Abstract Background Health care workers comprise a high-risk workgroup with respect to deterioration and early retirement. There is high prevalence of obesity and many of the workers are overweight. Together, these factors play a significant role in the health-related problems within this sector. The present study evaluates the effects of the first 3-months of a cluster randomized controlled lifestyle intervention among health care workers. The intervention addresses body weight, general health variables, physical capacity and musculoskeletal pain. Methods 98 female, overweight health care workers were cluster-randomized to an intervention group or a reference group. The intervention consisted of an individually dietary plan with an energy deficit of 1200 kcal/day (15 min/hour, strengthening exercises (15 min/hour and cognitive behavioral training (30 min/hour during working hours 1 hour/week. Leisure time aerobic fitness was planned for 2 hour/week. The reference group was offered monthly oral presentations. Body weight, BMI, body fat percentage (bioimpedance, waist circumference, blood pressure, musculoskeletal pain, maximal oxygen uptake (maximal bicycle test, and isometric maximal muscle strength of 3 body regions were measured before and after the intervention period. Results In an intention-to-treat analysis from pre to post tests, the intervention group significantly reduced body weight with 3.6 kg (p Conclusion The significantly reduced body weight, body fat, waist circumference and blood pressure as well as increased aerobic fitness in the intervention group show the great potential of workplace health promotion among this high-risk workgroup. Long-term effects of the intervention remain to be investigated. Trial registration ClinicalTrials.gov: NCT01015716

Treatment Effects of a Primary Care Intervention on Parenting Behaviors: Sometimes It's Relative.

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Shaffer, Anne; Lindhiem, Oliver; Kolko, David

2017-04-01

The goal of this brief report is to demonstrate the utility of quantifying parental discipline practices as relative frequencies in measuring changes in parenting behavior and relations to child behavior following intervention. We explored comparisons across methodological approaches of assessing parenting behavior via absolute and relative frequencies in measuring improvements in parent-reported disciplinary practices (increases in positive parenting practices in response to child behavior; decreases in inconsistent discipline and use of corporal punishment) and child behavior problems. The current study was conducted as part of a larger clinical trial to evaluate the efficacy of a collaborative care intervention for behavior problems, ADHD, and anxiety in pediatric primary care practices (Doctor Office Collaborative Care; DOCC). Participants were 321 parent-child dyads (M child age = 8.00, 65 % male children) from eight pediatric practices that were cluster randomized to DOCC or enhanced usual care (EUC). Parents reported on their own discipline behaviors and child behavior problems. While treatment-related decreases in negative parenting were found using both the absolute and relative frequencies of parenting behaviors, results were different for positive parenting behaviors, which showed decreases when measured as absolute frequencies but increases when measured as relative frequencies. In addition, positive parenting was negatively correlated with child behavior problems when using relative frequencies, but not absolute frequencies, and relative frequencies of positive parenting mediated relations between treatment condition and outcomes. Our findings indicate that the methods used to measure treatment-related change warrant careful consideration.

Implementing a patient education intervention about Methicillin-resistant Staphylococcus aureus prevention and effect on knowledge and behavior in veterans with spinal cord injuries and disorders: a pilot randomized controlled trial.

Science.gov (United States)

Evans, Charlesnika T; Hill, Jennifer N; Guihan, Marylou; Chin, Amy; Goldstein, Barry; Richardson, Michael S A; Anderson, Vicki; Risa, Kathleen; Kellie, Susan; Cameron, Kenzie A

2014-03-01

To assess the feasibility and effect of a nurse-administered patient educational intervention about Methicillin-resistant Staphylococcus aureus (MRSA) prevention on knowledge and behavior of Veterans with spinal cord injuries and disorders (SCI/D). Blinded, block-randomized controlled pilot trial. Two Department of Veterans Affairs (VA) SCI Centers. Veterans were recruited March-September 2010 through referral by a healthcare provider from inpatient, outpatient, and residential care settings. Thirty participants were randomized to the nurse-administered intervention and 31 to the usual care group. The intervention included a brochure and tools to assist nurses in conducting the education. Pre- and post-intervention measurement of knowledge and behaviors related to MRSA and prevention strategies and feasibility measures related to implementation. Participants were primarily male (95.1%), white (63.9%), with tetraplegia (63.9%) and mean age and duration of injury of 64.3 and 20.5 years, respectively. The intervention groups mean knowledge score significantly increased between pre- and post-test (mean change score = 1.70, 95% confidence interval, CI 0.25-3.15) while the usual care groups score did not significantly change (mean change score = 1.45, 95% CI -0.08-2.98). However, the mean knowledge change between intervention and usual care groups was not significantly different (P = 0.81). Overall behavior scores did not significantly differ between treatment groups; however, the intervention group was more likely to report intentions to clean hands (90.0% vs. 64.5%, P = 0.03) and asking providers about MRSA status (46.7% vs. 16.1%, P = 0.01). Nurse educators reported that the quality of the intervention was high and could be implemented in clinical care. A targeted educational strategy is feasible to implement in SCI/D clinical practices and may improve some participants' knowledge about MRSA and increase intentions to improve hand hygiene and engagement with providers

Mediation of effects of a theory-based behavioral intervention on self-reported physical activity in South African men.

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Jemmott, John B; Stephens-Shields, Alisa; O'Leary, Ann; Jemmott, Loretta Sweet; Teitelman, Anne; Ngwane, Zolani; Mtose, Xoliswa

2015-03-01

Increasing physical activity is an important public-health goal worldwide, but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases. This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1181 men in Eastern Cape Province, South Africa. Twenty-two matched-pairs of neighborhoods were randomly selected. Within pairs, neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline, immediate-post, and 6- and 12-month post-intervention assessments. Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome, self-reported physical activity averaged over the 6- and 12-month post-intervention assessments, using a product-of-coefficients approach in a generalized-estimating-equations framework. Data were collected in 2007-2010. Attitude, subjective norm, self-efficacy, and intention were significant mediators of intervention-induced increases in self-reported physical activity. The descriptive norm, not affected by the intervention, was not a mediator, but predicted increased self-reported physical activity. The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men. Copyright © 2015 Elsevier Inc. All rights reserved.

Multisite Randomized Trial of Behavioral Interventions for Women with Co-Occurring PTSD and Substance Use Disorders

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Hien, Denise A.; Wells, Elizabeth A.; Jiang, Huiping; Suarez-Morales, Lourdes; Campbell, Aimee N. C.; Cohen, Lisa R.; Miele, Gloria M.; Killeen, Therese; Brigham, Gregory S.; Zhang, Yulei; Hansen, Cheri; Hodgkins, Candace; Hatch-Maillette, Mary; Brown, Chanda; Kulaga, Agatha; Kristman-Valente, Allison; Chu, Melissa; Sage, Robert; Robinson, James A.; Liu, David; Nunes, Edward V.

2009-01-01

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353…

A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence

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Keoleian, Victoria; Stalcup, S. Alex; Polcin, Douglas L.; Brown, Michelle; Galloway, Gantt

2013-01-01

Psychosocial treatments for methamphetamine dependence are of limited effectiveness. Thus, a significant need exists for add-on therapy for this substance user disorder. The aim of this study was to develop and test a novel text messaging intervention for use as an adjunct to cognitive behavioral group therapy for methamphetamine users. Text messaging has the potential to support patients in real-time, around the clock. We convened 2 meetings of an expert panel, held 3 focus groups in current and former users, and conducted 15 semi-structured interviews with in-treatment users in order to develop a fully-automated, cognitive behavioral therapy-based text messaging intervention. We then conducted a randomized, crossover pre-test in 5 users seeking treatment. Participants’ ratings of ease of use and functionality of the system were high. During the pre-test we performed real-time assessments via text messaging on daily methamphetamine use, craving levels, and the perceived usefulness of messages; 79% of scheduled assessments were collected. The odds of messages being rated as “very” or “extremely” useful were 6.6 times [95% CI: 2.2, 19.4] higher in the active vs. placebo periods. The intervention is now ready for testing in randomized clinical trials. PMID:24592670

Body image and self-esteem among adolescents undergoing an intervention targeting dietary and physical activity behaviors.

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Huang, Jeannie S; Norman, Gregory J; Zabinski, Marion F; Calfas, Karen; Patrick, Kevin

2007-03-01

To determine the effect of a one-year intervention targeting physical activity, sedentary, and diet behaviors among adolescents on self-reported body image and self-esteem. Health promotion interventions can lead to awareness of health risk and subsequent adoption of beneficial changes in behavior. However, it is possible that interventions targeting behaviors associated with childhood obesity may also increase the likelihood of unhealthy eating and physical activity obsessions and behaviors. Body image and self-esteem were assessed for adolescents participating in the PACE+ study, a randomized controlled trial of a 1-year behavioral intervention targeting physical activity, sedentary, and dietary behaviors. The Body Dissatisfaction subscale of the Eating Disorder Inventory and Rosenberg Self-Esteem scale were used to assess body image and self-esteem, respectively, and measurements were performed at baseline, and at 6 and 12 months. Demographic characteristics and weight status of participants were also ascertained. Analysis of responses was performed via both between-group and within-group repeated measure analyses. There were 657 adolescents who completed all measurements. Body image differences were found for age, gender, and weight status at baseline, whereas self-esteem differences were demonstrated for gender, ethnicity, and weight status. There were no intervention effects on body image or self-esteem for either girls or boys. Self-esteem and body satisfaction did not worsen as a result of participating in the PACE+ intervention for either boys or girls whether or not they lost or maintained their weight or gained weight. Girls assigned to the PACE intervention who experienced weight reduction or weight maintenance at either 6 or 12 months reported improvements in body image satisfaction (p = .02) over time compared with subjects who had experienced weight gain during the 12-month study period. Adverse effects on body satisfaction and self-esteem were not

The effects of a 2-year individualized and family-based lifestyle intervention on physical activity, sedentary behavior and diet in children.

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Viitasalo, Anna; Eloranta, Aino-Maija; Lintu, Niina; Väistö, Juuso; Venäläinen, Taisa; Kiiskinen, Sanna; Karjalainen, Panu; Peltola, Jaana; Lampinen, Eeva-Kaarina; Haapala, Eero A; Paananen, Jussi; Schwab, Ursula; Lindi, Virpi; Lakka, Timo A

2016-06-01

To investigate the effects of a long-term, individualized and family-based lifestyle intervention on physical activity, sedentary behavior and diet quality in children. We carried out a 2-year intervention study in a population sample of 506 children aged 6-8years in Finland in 2007-2012. We allocated the participants at baseline in the intervention and control group. We assessed physical activity and sedentary behavior by questionnaires and diet by food records. Total physical activity (+9min/d in intervention group vs. -5min/d in control group, p=0.001 for time*group interaction), unsupervised physical activity (+7min/d vs. -9min/d, psedentary behavior and enhanced diet quality in children. ClinicalTrials.gov: NCT01803776. Copyright © 2016 Elsevier Inc. All rights reserved.

Pilot Trial of a Social Cognitive Theory-Based Physical Activity Intervention Delivered by Nonsupervised Technology in Persons With Multiple Sclerosis.

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Suh, Yoojin; Motl, Robert W; Olsen, Connor; Joshi, Ina

2015-07-01

Physical inactivity is prevalent in people with multiple sclerosis (MS) and this highlights the importance of developing behavioral interventions for increasing physical activity (PA) in MS. This pilot trial examined the efficacy of a 6-week, behavioral intervention based on social cognitive theory (SCT) delivered by newsletters and phone calls for increasing PA in persons with MS who were physically inactive and had middle levels of self-efficacy. The sample included 68 persons with relapsing-remitting MS who were randomly assigned into intervention and control groups. The intervention group received SCT-based information by newsletters and phone calls, whereas the controls received information regarding topics such as stress management over 6 weeks. Participants completed self-report of PA and social cognitive variables. The intervention group had a significant increase in self-reported PA (d = 0.56, P = .02) over the 6 weeks, but the controls had a nonsignificant change (d = -0.13, P = .45). Goal setting was changed in the intervention group (d = 0.68, P ≤ .01) and identified as a significant mediator of change in self-reported PA. This study provides initial evidence for the benefit of a theory-based behavioral intervention for increasing PA in MS.

A mental health intervention for schoolchildren exposed to violence: a randomized controlled trial.

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Stein, Bradley D; Jaycox, Lisa H; Kataoka, Sheryl H; Wong, Marleen; Tu, Wenli; Elliott, Marc N; Fink, Arlene

2003-08-06

No randomized controlled studies have been conducted to date on the effectiveness of psychological interventions for children with symptoms of posttraumatic stress disorder (PTSD) that has resulted from personally witnessing or being personally exposed to violence. To evaluate the effectiveness of a collaboratively designed school-based intervention for reducing children's symptoms of PTSD and depression that has resulted from exposure to violence. A randomized controlled trial conducted during the 2001-2002 academic year. Sixth-grade students at 2 large middle schools in Los Angeles who reported exposure to violence and had clinical levels of symptoms of PTSD. Students were randomly assigned to a 10-session standardized cognitive-behavioral therapy (the Cognitive-Behavioral Intervention for Trauma in Schools) early intervention group (n = 61) or to a wait-list delayed intervention comparison group (n = 65) conducted by trained school mental health clinicians. Students were assessed before the intervention and 3 months after the intervention on measures assessing child-reported symptoms of PTSD (Child PTSD Symptom Scale; range, 0-51 points) and depression (Child Depression Inventory; range, 0-52 points), parent-reported psychosocial dysfunction (Pediatric Symptom Checklist; range, 0-70 points), and teacher-reported classroom problems using the Teacher-Child Rating Scale (acting out, shyness/anxiousness, and learning problems; range of subscales, 6-30 points). Compared with the wait-list delayed intervention group (no intervention), after 3 months of intervention students who were randomly assigned to the early intervention group had significantly lower scores on symptoms of PTSD (8.9 vs 15.5, adjusted mean difference, - 7.0; 95% confidence interval [CI], - 10.8 to - 3.2), depression (9.4 vs 12.7, adjusted mean difference, - 3.4; 95% CI, - 6.5 to - 0.4), and psychosocial dysfunction (12.5 vs 16.5, adjusted mean difference, - 6.4; 95% CI, -10.4 to -2.3). Adjusted

Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program.

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Murphy, Debra A; Armistead, Lisa; Payne, Diana L; Marelich, William D; Herbeck, Diane M

2017-01-01

A pilot study was conducted to assess the effects of the IMAGE pilot intervention (Improving Mothers' parenting Abilities, Growth, and Effectiveness) on mothers living with HIV (MLH). Based on Fisher and Fisher's IMB model [1992. Changing AIDS risk behavior. Psychological Bulletin, 111, 455-474], the intervention focused on self-care and parenting behavior skills of MLH that affect maternal, child, and family outcomes. A randomized pre-test-post-test two-group design with repeated assessments was used. MLH (n = 62) and their children aged 6-14 (n = 62; total N = 124) were recruited for the trial and randomized to the theory-based skills training condition or a standard care control condition. Assessments were conducted at baseline with follow-ups at 3, 6, and 12 months. Maternal, child, and family outcomes were assessed. Results show significant effects of the intervention for improving parenting practices for mothers. The intervention also improved family outcomes, and showed improvements in the parent-child relationship. IMAGE had a positive impact on parenting behaviors, and on maternal, child, and family outcomes. Given MLH can be challenged by their illness and also live in under-resourced environments, IMAGE may be viewed as a viable way to improve quality of life and family outcomes.

Behavioral medicine interventions for adult primary care settings: A review.

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Funderburk, Jennifer S; Shepardson, Robyn L; Wray, Jennifer; Acker, John; Beehler, Gregory P; Possemato, Kyle; Wray, Laura O; Maisto, Stephen A

2018-06-07

Health care organizations are embracing integrated primary care (IPC), in which mental health and behavioral health are addressed as part of routine care within primary care settings. Behavioral medicine concerns, which include health behavior change and coping with medical conditions, are common in primary care populations. Although there are evidence-based behavioral interventions that target a variety of behavioral medicine concerns, integrated behavioral health providers need interventions that are sufficiently brief (i.e., ≤6 appointments) to be compatible with IPC. We conducted a literature review of published studies examining behavioral interventions that target prevalent behavioral medicine concerns and can feasibly be employed by IPC providers in adult primary care settings. A total of 67 published articles representing 63 original studies met eligibility criteria. We extracted data on the behavioral interventions employed, results comparing the active intervention to a comparison group, general fit with IPC, and methodological quality. The vast majority of studies examined brief interventions targeting sleep difficulties and physical activity. The most commonly employed interventions were derived from cognitive-behavioral therapy and motivational interviewing. Outcomes were generally statistically significantly in favor of the active intervention relative to comparison, with highly variable methodological quality ratings (range = 0-5; M = 2.0). Results are discussed in relation to the need for further evidence for brief behavioral interventions targeting other behavioral medicine concerns beyond sleep and physical activity, as well as for more specificity regarding the compatibility of such interventions with IPC practice. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Weight Loss Maintenance in African American Women: A Systematic Review of the Behavioral Lifestyle Intervention Literature

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Lisa M. Tussing-Humphreys

2013-01-01

Full Text Available We performed a systematic review of the behavioral lifestyle intervention trials conducted in the United States published between 1990 and 2011 that included a maintenance phase of at least six months, to identify intervention features that promote weight loss maintenance in African American women. Seventeen studies met the inclusion criteria. Generally, African American women lost less weight during the intensive weight loss phase and maintained a lower % of their weight loss compared to Caucasian women. The majority of studies failed to describe the specific strategies used in the delivery of the maintenance intervention, adherence to those strategies, and did not incorporate a maintenance phase process evaluation making it difficult to identify intervention characteristics associated with better weight loss maintenance. However, the inclusion of cultural adaptations, particularly in studies with a mixed ethnicity/race sample, resulted in less % weight regain for African American women. Studies with a formal maintenance intervention and weight management as the primary intervention focus reported more positive weight maintenance outcomes for African American women. Nonetheless, our results present both the difficulty in weight loss and maintenance experienced by African American women in behavioral lifestyle interventions.

Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).

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Wallander, Jan L; McClure, Elizabeth; Biasini, Fred; Goudar, Shivaprasad S; Pasha, Omrana; Chomba, Elwyn; Shearer, Darlene; Wright, Linda; Thorsten, Vanessa; Chakraborty, Hrishikesh; Dhaded, Sangappa M; Mahantshetti, Niranjana S; Bellad, Roopa M; Abbasi, Zahid; Carlo, Waldemar

2010-04-30

This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential

An adaptive physical activity intervention for overweight adults: a randomized controlled trial.

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Marc A Adams

Full Text Available Physical activity (PA interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible.To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention.Participants (N = 20 were randomized to one of two 6-month treatments: 1 static intervention (SI or 2 adaptive intervention (AI. Inactive overweight adults (85% women, M = 36.9 ± 9.2 years, 35% non-white in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data.A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001 and a group by study phase interaction was observed (p  .017. The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74.The adaptive intervention outperformed the static intervention for increasing

A randomized intervention trial to reduce the lending of used injection equipment among injection drug users infected with hepatitis C.

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Latka, Mary H; Hagan, Holly; Kapadia, Farzana; Golub, Elizabeth T; Bonner, Sebastian; Campbell, Jennifer V; Coady, Micaela H; Garfein, Richard S; Pu, Minya; Thomas, Dave L; Thiel, Thelma K; Strathdee, Steffanie A

2008-05-01

We evaluated the efficacy of a peer-mentoring behavioral intervention designed to reduce risky distributive injection practices (e.g., syringe lending, unsafe drug preparation) among injection drug users with hepatitis C virus (HCV) infection. A randomized trial with a time-equivalent attention-control group was conducted among 418 HCV-positive injection drug users aged 18 to 35 years in 3 US cities. Participants reported their injection-related behaviors at baseline and at 3- and 6-month follow-ups. Compared with the control group, intervention-group participants were less likely to report distributive risk behaviors at 3 months (odds ratio [OR]=0.46; 95% confidence interval [CI]=0.27, 0.79) and 6 months (OR=0.51; 95% CI=0.31, 0.83), a 26% relative risk reduction, but were no more likely to cite their HCV-positive status as a reason for refraining from syringe lending. Effects were strongest among intervention-group participants who had known their HCV-positive status for at least 6 months. Peer mentoring and self-efficacy were significantly increased among intervention-group participants, and intervention effects were mediated through improved self-efficacy. This behavioral intervention reduced unsafe injection practices that may propagate HCV among injection drug users.

Strengths-Based Behavioral Intervention for Parents of Adolescents With Type 1 Diabetes Using an mHealth App (Type 1 Doing Well): Protocol for a Pilot Randomized Controlled Trial.

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Hilliard, Marisa E; Eshtehardi, Sahar S; Minard, Charles G; Saber, Rana; Thompson, Debbe; Karaviti, Lefkothea P; Rojas, Yuliana; Anderson, Barbara J

2018-03-13

Supportive parent involvement for adolescents' type 1 diabetes (T1D) self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. The aim of this protocol was to describe the development of a new, strengths-based behavioral intervention for parents of adolescents with T1D delivered via a mobile-friendly Web app called Type 1 Doing Well. Ten adolescent-parent dyads and 5 diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3- to 4-month pilot intervention will involve 82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (ie, positive attitudes or behaviors related to living with or managing T1D) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen's most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages (short message service, SMS). The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. This strengths-based, mobile health (mHealth) intervention aims to help parents increase their awareness of and efforts to support their adolescents' engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative

The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia: a randomized controlled trial

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Prick AE

2016-03-01

Full Text Available Anna-Eva Prick,1 Jacomine de Lange,2 Erik Scherder,3 Jos Twisk,4 Anne Margriet Pot1,5,6 1Department of Clinical Psychology and the EMGO+ Institute for Health and Care Research, Faculty of Psychology and Education, VU University, Amsterdam, the Netherlands; 2Research Centre Innovations in Care, Rotterdam University of Applied Sciences, Rotterdam, the Netherlands; 3Department of Clinical Neuropsychology, Faculty of Psychology and Education, VU University, Amsterdam, the Netherlands; 4Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands; 5Program on Ageing, Institute of Mental Health and Addiction, Utrecht, the Netherlands; 6School of Psychology, University of Queensland, Brisbane, QLD, Australia Purpose: The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia living in the community were evaluated in a randomized controlled trial. This multicomponent dyadic intervention is a translated and adapted version of an intervention that has been shown to be effective for people with dementia in the US. Patients and methods: People with dementia living in the community and their family caregivers (N=111 caregiver-care recipient dyads were randomly assigned to the intervention and comparison group. The intervention group received home-based physical exercise training, psycho-education, communication skills training, and pleasant activities training during 3 months directed at both the person with dementia and the caregiver. Mood, behavior, and physical health were measured at baseline, 3 months, and 6 months. The effects of the study were determined by using generalized estimating equations based on an intention-to-treat analysis. Results: Analyses showed no beneficial effects over time on any of the outcome measures. Conclusion: This study showed no effects. The negative results in this study

Web-Delivered Cognitive Behavioral Therapy for Distressed Cancer Patients: Randomized Controlled Trial.

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Chambers, Suzanne K; Ritterband, Lee M; Thorndike, Frances; Nielsen, Lisa; Aitken, Joanne F; Clutton, Samantha; Scuffham, Paul A; Youl, Philippa; Morris, Bronwyn; Baade, Peter D; Dunn, Jeff

2018-01-31

Web-based interventions present a potentially cost-effective approach to supporting self-management for cancer patients; however, further evidence for acceptability and effectiveness is needed. The goal of our research was to assess the effectiveness of an individualized Web-based cognitive behavioral therapy (CBT) intervention on improving psychological and quality of life outcomes in cancer patients with elevated psychological distress. A total of 163 distressed cancer patients (111 female, 68.1%) were recruited through the Queensland Cancer Registry and the Cancer Council Queensland Cancer Helpline and randomly assigned to either a Web-based tailored CBT intervention (CancerCope) (79/163) or a static patient education website (84/163). At baseline and 8-week follow-up we assessed primary outcomes of psychological and cancer-specific distress and unmet psychological supportive care needs and secondary outcomes of positive adjustment and quality of life. Intention-to-treat analyses showed no evidence of a statistically significant intervention effect on primary or secondary outcomes. However, per-protocol analyses found a greater decrease for the CancerCope group in psychological distress (P=.04), cancer-specific distress (P=.02), and unmet psychological care needs (P=.03) from baseline to 8 weeks compared with the patient education group. Younger patients were more likely to complete the CancerCope intervention. This online CBT intervention was associated with greater decreases in distress for those patients who more closely adhered to the program. Given the low costs and high accessibility of this intervention approach, even if only effective for subgroups of patients, the potential impact may be substantial. Australian New Zealand Clinical Trials Registry ACTRN12613001026718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364768&isReview=true (Archived by WebCite at http://www.webcitation.org/6uPvpcovl). ©Suzanne K Chambers, Lee M Ritterband

Determining who responds better to a computer- vs. human-delivered physical activity intervention: results from the community health advice by telephone (CHAT) trial

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2013-01-01

Background Little research has explored who responds better to an automated vs. human advisor for health behaviors in general, and for physical activity (PA) promotion in particular. The purpose of this study was to explore baseline factors (i.e., demographics, motivation, interpersonal style, and external resources) that moderate intervention efficacy delivered by either a human or automated advisor. Methods Data were from the CHAT Trial, a 12-month randomized controlled trial to increase PA among underactive older adults (full trial N = 218) via a human advisor or automated interactive voice response advisor. Trial results indicated significant increases in PA in both interventions by 12 months that were maintained at 18-months. Regression was used to explore moderation of the two interventions. Results Results indicated amotivation (i.e., lack of intent in PA) moderated 12-month PA (d = 0.55, p  0.12). Conclusions Results provide preliminary evidence for generating hypotheses about pathways for supporting later clinical decision-making with regard to the use of either human- vs. computer-delivered interventions for PA promotion. PMID:24053756

Effectiveness of an Intervention for Children with Externalizing Behavior and Mild to Borderline Intellectual Disabilities: A Randomized Trial

NARCIS (Netherlands)

Schuiringa, Hilde; Van Nieuwenhuijzen, Maroesjka; Orobio De Castro, Bram; Lochman, John E.; Matthys, Walter

2017-01-01

This study evaluated the effectiveness of Standing Strong Together (SST), a combined group based parent and child intervention for externalizing behavior in 9–16 year-old children with mild to borderline intellectual disabilities (MBID). Children with externalizing behavior and MBID (IQ from 55 to

Testing sex-specific pathways from peer victimization to anxiety and depression in early adolescents through a randomized intervention trial

NARCIS (Netherlands)

Vuijk, P.; Lier, P.A.C. van; Crijnen, A.A.M.; Huizink, A.C.

2007-01-01

The aim of this study was to test for sex differences in the role of physical and relational victimization in anxiety and depression development through a randomized prevention trial. 448 seven-year-old boys and girls were randomly assigned to the Good Behavior Game intervention, a two-year

A Pilot Intervention Designed to Address Behavioral Factors That Place Overweight/Obese Young Children at Risk for Later-Life Obesity.

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Small, Leigh; Thacker, Leroy; Aldrich, Heather; Bonds-McClain, Darya; Melnyk, Bernadette

2017-08-01

The purpose of this pilot randomized controlled trial (RCT) was to intervene with parents of overweight/obese 4- to 8-year-old children to improve child internalizing and externalizing behaviors. Parent-child dyads ( N = 60) were randomly assigned to treatment or comparison conditions. Parents attended four intervention sessions at their child's primary health care office over 3 months. Child behaviors were assessed at 0, 3, 6, and 12 months post intervention. Parental beliefs in their skills/abilities increased in the experimental group parents, but there was no statistical difference between groups at any time. Child externalizing behaviors significantly decreased from baseline to postintervention for both groups ( F = 3.26, p = .020). Post hoc model testing suggests that this change was more pronounced in the intervention group ( F = 0.56, p = .692). Child somatic symptoms significantly decreased over time ( F = 4.55, p = .004), and there were group differences in child depressive behaviors ( F = 6.19, p = .020). These findings suggest that a parent-focused intervention program demonstrated positive preliminary effects on children's behaviors.

PREVIEW behavior modification intervention toolbox (PREMIT: a study protocol for a psychological element of a multicenter project

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Daniela Kahlert

2016-08-01

Full Text Available Background: Losing excess body weight and preventing weight regain by changing lifestyle is a challenging but promising task to prevent the incidence of type-2 diabetes. To be successful, it is necessary to use evidence-based and theory-driven interventions, which also contribute to the science of behavior modification by providing a deeper understanding of successful intervention components. Objective: To develop a physical activity and dietary behavior modification intervention toolbox (PREMIT that fulfills current requirements of being theory-driven and evidence-based, comprehensively described and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counselling approach. Methods: The program development took five progressive steps, in line with the Public Health Action Cycle: (1 Summing-up the intervention goal(s, target group and the setting, (2 uncovering the generative psychological mechanisms, (3 identifying behavior change techniques and tools, (4 preparing for evaluation and (5 implementing the intervention and assuring quality. Results: PREMIT is based on a trans-theoretical approach referring to valid behavior modification theories, models and approaches. A major ‘product’ of PREMIT is a matrix, constructed for use by onsite-instructors. The matrix includes objectives, tasks and activities ordered by periods. PREMIT is constructed to help instructors guide participant’s behavior change. To ensure high fidelity and adherence of program-implementation across the eight intervention centers standardized operational procedures were defined and train-the-trainer workshops were held. In summary PREMIT is a theory-driven, evidence-based program carefully developed to change physical activity and dietary behaviors in pre

PREVIEW Behavior Modification Intervention Toolbox (PREMIT): A Study Protocol for a Psychological Element of a Multicenter Project.

Science.gov (United States)

Kahlert, Daniela; Unyi-Reicherz, Annelie; Stratton, Gareth; Meinert Larsen, Thomas; Fogelholm, Mikael; Raben, Anne; Schlicht, Wolfgang

2016-01-01

Losing excess body weight and preventing weight regain by changing lifestyle is a challenging but promising task to prevent the incidence of type-2 diabetes. To be successful, it is necessary to use evidence-based and theory-driven interventions, which also contribute to the science of behavior modification by providing a deeper understanding of successful intervention components. To develop a physical activity and dietary behavior modification intervention toolbox (PREMIT) that fulfills current requirements of being theory-driven and evidence-based, comprehensively described and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counseling approach. The program development took five progressive steps, in line with the Public Health Action Cycle: (1) Summing-up the intervention goal(s), target group and the setting, (2) uncovering the generative psychological mechanisms, (3) identifying behavior change techniques and tools, (4) preparing for evaluation and (5) implementing the intervention and assuring quality. PREMIT is based on a trans-theoretical approach referring to valid behavior modification theories, models and approaches. A major "product" of PREMIT is a matrix, constructed for use by onsite-instructors. The matrix includes objectives, tasks and activities ordered by periods. PREMIT is constructed to help instructors guide participants' behavior change. To ensure high fidelity and adherence of program-implementation across the eight intervention centers standardized operational procedures were defined and "train-the-trainer" workshops were held. In summary PREMIT is a theory-driven, evidence-based program carefully developed to change physical activity and dietary behaviors in pre-diabetic people.

Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

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Mustila Taina

2012-07-01

Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710

Implementation-effectiveness trial of an ecological intervention for physical activity in ethnically diverse low income senior centers

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Porchia Rich

2017-07-01

Full Text Available Abstract Background As the US population ages, there is an increasing need for evidence based, peer-led physical activity programs, particularly in ethnically diverse, low income senior centers where access is limited. Methods/design The Peer Empowerment Program 4 Physical Activity’ (PEP4PA is a hybrid Type II implementation-effectiveness trial that is a peer-led physical activity (PA intervention based on the ecological model of behavior change. The initial phase is a cluster randomized control trial randomized to either a peer-led PA intervention or usual center programming. After 18 months, the intervention sites are further randomized to continued support or no support for another 6 months. This study will be conducted at twelve senior centers in San Diego County in low income, diverse communities. In the intervention sites, 24 peer health coaches and 408 adults, aged 50 years and older, are invited to participate. Peer health coaches receive training and support and utilize a tablet computer for delivery and tracking. There are several levels of intervention. Individual components include pedometers, step goals, counseling, and feedback charts. Interpersonal components include group walks, group sharing and health tips, and monthly celebrations. Community components include review of PA resources, walkability audit, sustainability plan, and streetscape improvements. The primary outcome of interest is intensity and location of PA minutes per day, measured every 6 months by wrist and hip accelerometers and GPS devices. Secondary outcomes include blood pressure, physical, cognitive, and emotional functioning. Implementation measures include appropriateness & acceptability (perceived and actual fit, adoption & penetration (reach, fidelity (quantity & quality of intervention delivered, acceptability (satisfaction, costs, and sustainability. Discussion Using a peer led implementation strategy to deliver a multi-level community based PA

Ethical issues in a stage 1 cognitive-behavioral therapy feasibility study and trial to reduce alcohol use among HIV-infected outpatients in western Kenya.

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Papas, Rebecca K; Gakinya, Benson N; Baliddawa, Joyce B; Martino, Steve; Bryant, Kendall J; Meslin, Eric M; Sidle, John E

2012-07-01

Epidemics of both HIV/AIDS and alcohol abuse in sub-Saharan Africa have spurred the conduct of local behavioral therapy trials for these problems, but the ethical issues involved in these trials have not been fully examined. In this paper, we discuss ethical issues that emerged during the conduct of a behavioral intervention adaptation and trial using cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. The study was performed within our multinational collaboration, the USAID-Academic Model Providing Access to Healthcare Partnership. We discuss relevant ethical considerations and how we addressed them.

Changing energy-related behavior: An Intervention Mapping approach

International Nuclear Information System (INIS)

Kok, Gerjo; Lo, Siu Hing; Peters, Gjalt-Jorn Y.; Ruiter, Robert A.C.

2011-01-01

This paper's objective is to apply Intervention Mapping, a planning process for the systematic development of theory- and evidence-based health promotion interventions, to the development of interventions to promote energy conservation behavior. Intervention Mapping (IM) consists of six steps: needs assessment, program objectives, methods and applications, program development, planning for program implementation, and planning for program evaluation. Examples from the energy conservation field are provided to illustrate the activities associated with these steps. It is concluded that applying IM in the energy conservation field may help the development of effective behavior change interventions, and thus develop a domain specific knowledge-base for effective intervention design. - Highlights: → Intervention Mapping (IM) is a planning process for developing evidence-based interventions.→ IM takes a problem-driven rather than theory-driven approach. → IM can be applied to the promotion of energy-conservation in a multilevel approach. → IM helps identifying determinants of behaviors and environmental conditions. → IM helps selecting appropriate theory-based methods and practical applications.

Changing energy-related behavior: An Intervention Mapping approach

Energy Technology Data Exchange (ETDEWEB)

Kok, Gerjo, E-mail: g.kok@maastrichtuniversity.nl [Department of Work and Social Psychology, Maastricht University, P.O. Box 616, 6200 MD Maastricht (Netherlands); Lo, Siu Hing, E-mail: siu-hing.lo@maastrichtuniversity.nl [Department of Work and Social Psychology, Maastricht University, P.O. Box 616, 6200 MD Maastricht (Netherlands); Peters, Gjalt-Jorn Y., E-mail: gj.peters@maastrichtuniversity.nl [Department of Work and Social Psychology, Maastricht University, P.O. Box 616, 6200 MD Maastricht (Netherlands); Ruiter, Robert A.C., E-mail: r.ruiter@maastrichtuniversity.nl [Department of Work and Social Psychology, Maastricht University, P.O. Box 616, 6200 MD Maastricht (Netherlands)

2011-09-15

This paper's objective is to apply Intervention Mapping, a planning process for the systematic development of theory- and evidence-based health promotion interventions, to the development of interventions to promote energy conservation behavior. Intervention Mapping (IM) consists of six steps: needs assessment, program objectives, methods and applications, program development, planning for program implementation, and planning for program evaluation. Examples from the energy conservation field are provided to illustrate the activities associated with these steps. It is concluded that applying IM in the energy conservation field may help the development of effective behavior change interventions, and thus develop a domain specific knowledge-base for effective intervention design. - Highlights: > Intervention Mapping (IM) is a planning process for developing evidence-based interventions.> IM takes a problem-driven rather than theory-driven approach. > IM can be applied to the promotion of energy-conservation in a multilevel approach. > IM helps identifying determinants of behaviors and environmental conditions. > IM helps selecting appropriate theory-based methods and practical applications.

An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial.

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Rachyla, Iryna; Pérez-Ara, Marian; Molés, Mar; Campos, Daniel; Mira, Adriana; Botella, Cristina; Quero, Soledad

2018-05-31

Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet

Parenting Intervention for Prevention of Behavioral Problems in Elementary School-Age Filipino-American Children: A Pilot Study in Churches.

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Javier, Joyce R; Coffey, Dean M; Schrager, Sheree M; Palinkas, Lawrence A; Miranda, Jeanne

This study aims to test an evidence-based parenting program offered in churches among Filipino-American parents and estimate effect size for a fully powered trial. Twenty-two parents of children aged 6 to 12 years were randomly assigned to either an intervention or a waiting-list control group. Parents' perceptions of child behavior, parenting practices, and parenting stress were obtained at baseline. Parents in the experimental group attended The Incredible Years School Age Program, which consisted of 12 weekly 2-hour sessions. A follow-up assessment was performed after the intervention and 12 weeks later. The intervention was subsequently repeated with the control group. Satisfaction was assessed with a 40-item measure. Analysis of covariance was used to compare the intervention group postintervention versus the control group. Paired t-tests compared mean parenting practices, parenting stress, and child behavior outcomes. Satisfaction was assessed descriptively. Twenty-two parents completed all assessments and the intervention. Analysis of variance comparing intervention and control groups with repeated measures (pre- and post-test measures) revealed that the program has a positive impact on parenting stress, parenting practices (physical punishment, positive verbal discipline), and parent's perception of their child's behavior (internalizing symptoms, externalizing symptoms, and number of problematic behaviors). Analyses of all participants comparing pre- and post intervention revealed improvements in parenting stress, positive verbal discipline, and child externalizing and total problem behaviors. Families reported high satisfaction with the content and format of the intervention. Results support the feasibility of providing an evidence-based parenting program to Filipino parents in churches to prevent future behavioral health problems.

Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT

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Mahantshetti Niranjana S

2010-04-01

Full Text Available Abstract Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring

Psychosocial interventions for the diabetic patient

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Harvey JN

2015-01-01

Full Text Available John N Harvey Diabetes Research Group, Wrexham Academic Unit, Bangor University, Wrexham, UK Abstract: Diabetes usually requires substantial life-long self-management by the patient. Psychological factors and the patient's health beliefs are important determinants of self-care behavior. Education has a modest influence on generating better self-care, but psychologically based interventions are clearly more effective. This review gives an overview of these interventions with some discussion of their basis in psychological theory. Some labels such as cognitive behavioral therapy and family therapy include a wide range of approaches. Randomized trials have generally produced improvement in measures of psychological well-being, but improved glycemic control has been more elusive. The influence on behavior can be very dependent on the individual therapist. Only a few trials have managed to sustain improvement in glycosylated hemoglobin beyond a year. Not all patients are prepared to engage and accept these forms of therapeutic intervention. We are still some way from moving psychological management from the trial situation into the diabetic clinic. Keywords: health beliefs, motivational interviewing, cognitive behavioral therapy, family therapy, adolescence

Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.

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Go, Vivian F; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W; Zelaya, Carla; Vu, Pham The; Celentano, David D; Quan, Vu Minh

2015-01-01

Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. ClinicalTrials.gov NCT01689545.

Internet-delivered eating disorder prevention: A randomized controlled trial of dissonance-based and cognitive-behavioral interventions.

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Chithambo, Taona P; Huey, Stanley J

2017-10-01

The current study evaluated two web-based programs for eating disorder prevention in high-risk, predominantly ethnic minority women. Two hundred and seventy-one women with elevated weight concerns were randomized to Internet dissonance-based intervention (DBI-I), Internet cognitive-behavioral intervention (CBI-I), or no intervention (NI). Both interventions consisted of four weekly online sessions. Participants were assessed at pre- and post intervention. Outcome measures included eating pathology, body dissatisfaction, dieting, thin-ideal internalization, and depression. At postintervention, DBI-I and CBI-I led to greater reductions in body dissatisfaction, thin-ideal internalization, and depression than NI. In addition, CBI-I was effective at reducing dieting and composite eating pathology relative to NI. No outcome differences were found between the active conditions. Moderation analyses suggested that both active conditions were more effective for ethnic minorities than Whites relative to NI. Results suggest that both DBI-I and CBI-I are effective at reducing eating disorder risk factors in a high-risk, predominantly minority population relative to no intervention. © 2017 Wiley Periodicals, Inc.

Behavioral interventions for office-based care: behavior change.

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Delfino, Matthew; Larzelere, Michele McCarthy

2014-03-01

Family physicians play an important role in identifying and treating the behavioral etiologies of morbidity and mortality. Changing behavior is a challenging process that begins with identifying a patient's readiness to change. Interventions, such as motivational interviewing, are used to increase a patient's desire to change, and cognitive behavioral therapy can be initiated to increase a patient's likelihood of change, particularly if barriers are identified. After patients embark on change, family physicians are uniquely positioned to connect them to self-help programs, more intensive psychotherapy, and newer technology-based support programs, and to provide repeated, brief, positive reinforcement. Specific behavioral interventions that can be effective include computerized smoking cessation programs; electronic reminders and support delivered by family physicians or other clinicians for weight loss; linkage to community-based programs for seniors; increased length and demands of in-school programs to support exercise participation by children; and access reduction education to prevent firearm injury. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Effects of a web-based tailored multiple-lifestyle intervention for adults: a two-year randomized controlled trial comparing sequential and simultaneous delivery modes.

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Schulz, Daniela N; Kremers, Stef P J; Vandelanotte, Corneel; van Adrichem, Mathieu J G; Schneider, Francine; Candel, Math J J M; de Vries, Hein

2014-01-27

Web-based computer-tailored interventions for multiple health behaviors can have a significant public health impact. Yet, few randomized controlled trials have tested this assumption. The objective of this paper was to test the effects of a sequential and simultaneous Web-based tailored intervention on multiple lifestyle behaviors. A randomized controlled trial was conducted with 3 tailoring conditions (ie, sequential, simultaneous, and control conditions) in the Netherlands in 2009-2012. Follow-up measurements took place after 12 and 24 months. The intervention content was based on the I-Change model. In a health risk appraisal, all respondents (N=5055) received feedback on their lifestyle behaviors that indicated whether they complied with the Dutch guidelines for physical activity, vegetable consumption, fruit consumption, alcohol intake, and smoking. Participants in the sequential (n=1736) and simultaneous (n=1638) conditions received tailored motivational feedback to change unhealthy behaviors one at a time (sequential) or all at the same time (simultaneous). Mixed model analyses were performed as primary analyses; regression analyses were done as sensitivity analyses. An overall risk score was used as outcome measure, then effects on the 5 individual lifestyle behaviors were assessed and a process evaluation was performed regarding exposure to and appreciation of the intervention. Both tailoring strategies were associated with small self-reported behavioral changes. The sequential condition had the most significant effects compared to the control condition after 12 months (T1, effect size=0.28). After 24 months (T2), the simultaneous condition was most effective (effect size=0.18). All 5 individual lifestyle behaviors changed over time, but few effects differed significantly between the conditions. At both follow-ups, the sequential condition had significant changes in smoking abstinence compared to the simultaneous condition (T1 effect size=0.31; T2 effect

Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial.

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Himes, Katherine Park; Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

2017-10-10

During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and

A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial.

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Maher, Carol; Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

2015-07-13

Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online social networking physical activity intervention which included self-monitoring, social elements, and pedometers ("Active Team" Facebook app; n=51 individuals, 12 teams) or a wait-listed control condition (n=59 individuals, 13 teams). Assessments were undertaken online at baseline, 8 weeks, and 20 weeks. The primary outcome measure was self-reported weekly moderate-to-vigorous physical activity (MVPA). Secondary outcomes were weekly walking, vigorous physical activity time, moderate physical activity time, overall quality of life, and mental health quality of life. Analyses were undertaken using random-effects mixed modeling, accounting for potential clustering at the team level. Usage statistics were reported descriptively to determine engagement and feasibility. At the 8-week follow-up, the intervention participants had significantly increased their total weekly MVPA by 135 minutes relative to the control group (P=.03), due primarily to increases in walking time (155 min/week increase relative to controls, Plife or mental health quality of life at either time point. High levels of engagement with the intervention, and particularly the self-monitoring features, were observed. An online, social networking physical activity intervention with pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Australian New Zealand

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

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Rushing, J; Wing, R; Wadden, T A; Knowler, W C; Lawlor, M; Evans, M; Killean, T; Montez, M; Espeland, M A; Zhang, P

2017-03-01

The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

Effectiveness of a Worksite Social & Physical Environment Intervention on Need for Recovery, Physical Activity and Relaxation; Results of a Randomized Controlled Trial

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Coffeng, Jennifer K.; Boot, Cécile R. L.; Duijts, Saskia F. A.; Twisk, Jos W. R.; van Mechelen, Willem; Hendriksen, Ingrid J. M.

2014-01-01

Objective To investigate the effectiveness of a worksite social and physical environment intervention on need for recovery (i.e., early symptoms of work-related mental and physical fatigue), physical activity and relaxation. Also, the effectiveness of the separate interventions was investigated. Methods In this 2×2 factorial design study, 412 office employees from a financial service provider participated. Participants were allocated to the combined social and physical intervention, to the social intervention only, to the physical intervention only or to the control group. The primary outcome measure was need for recovery. Secondary outcomes were work-related stress (i.e., exhaustion, detachment and relaxation), small breaks, physical activity (i.e., stair climbing, active commuting, sport activities, light/moderate/vigorous physical activity) and sedentary behavior. Outcomes were measured by questionnaires at baseline, 6 and 12 months follow-up. Multilevel analyses were performed to investigate the effects of the three interventions. Results In all intervention groups, a non-significant reduction was found in need for recovery. In the combined intervention (n = 92), exhaustion and vigorous physical activities decreased significantly, and small breaks at work and active commuting increased significantly compared to the control group. The social intervention (n = 118) showed a significant reduction in exhaustion, sedentary behavior at work and a significant increase in small breaks at work and leisure activities. In the physical intervention (n = 96), stair climbing at work and active commuting significantly increased, and sedentary behavior at work decreased significantly compared to the control group. Conclusion None of the interventions was effective in improving the need for recovery. It is recommended to implement the social and physical intervention among a population with higher baseline values of need for recovery. Furthermore, the intervention

Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial.

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Storm, Vera; Dörenkämper, Julia; Reinwand, Dominique Alexandra; Wienert, Julian; De Vries, Hein; Lippke, Sonia

2016-04-11

Web-based computer-tailored interventions for multiple health behaviors can improve the strength of behavior habits in people who want to reduce their cardiovascular risk. Nonetheless, few randomized controlled trials have tested this assumption to date. The study aim was to test an 8-week Web-based computer-tailored intervention designed to improve habit strength for physical activity and fruit and vegetable consumption among people who want to reduce their cardiovascular risk. In a randomized controlled design, self-reported changes in perceived habit strength, self-efficacy, and planning across different domains of physical activity as well as fruit and vegetable consumption were evaluated. This study was a randomized controlled trial involving an intervention group (n=403) and a waiting control group (n=387). Web-based data collection was performed in Germany and the Netherlands during 2013-2015. The intervention content was based on the Health Action Process Approach and involved personalized feedback on lifestyle behaviors, which indicated whether participants complied with behavioral guidelines for physical activity and fruit and vegetable consumption. There were three Web-based assessments: baseline (T0, N=790), a posttest 8 weeks after the baseline (T1, n=206), and a follow-up 3 months after the baseline (T2, n=121). Data analysis was conducted by analyzing variances and structural equation analysis. Significant group by time interactions revealed superior treatment effects for the intervention group, with substantially higher increases in self-reported habit strength for physical activity (F1,199=7.71, P=.006, Cohen's d=0.37) and fruit and vegetable consumption (F1,199=7.71, P=.006, Cohen's d=0.30) at posttest T1 for the intervention group. Mediation analyses yielded behavior-specific sequential mediator effects for T1 planning and T1 self-efficacy between the intervention and habit strength at follow-up T2 (fruit and vegetable consumption: beta=0.12, 95

A randomized controlled trial testing a social network intervention to promote physical activity among adolescents.

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van Woudenberg, Thabo J; Bevelander, Kirsten E; Burk, William J; Smit, Crystal R; Buijs, Laura; Buijzen, Moniek

2018-04-23

The current study examined the effectiveness of a social network intervention to promote physical activity among adolescents. Social network interventions utilize peer influence to change behavior by identifying the most influential individuals within social networks (i.e., influence agents), and training them to promote the target behavior. A total of 190 adolescents (46.32% boys; M age = 12.17, age range: 11-14 years) were randomly allocated to either the intervention or control condition. In the intervention condition, the most influential adolescents (based on peer nominations of classmates) in each classroom were trained to promote physical activity among their classmates. Participants received a research smartphone to complete questionnaires and an accelerometer to measure physical activity (steps per day) at baseline, and during the intervention one month later. A multilevel model tested the effectiveness of the intervention, controlling for clustering of data within participants and days. No intervention effect was observed, b = .04, SE = .10, p = .66. This was one of the first studies to test whether physical activity in adolescents could be promoted via influence agents, and the first social network intervention to use smartphones to do so. Important lessons and implications are discussed concerning the selection criterion of the influence agents, the use of smartphones in social network intervention, and the rigorous analyses used to control for confounding factors. Dutch Trial Registry (NTR): NTR6173 . Registered 5 October 2016 Study procedures were approved by the Ethics Committee of the Radboud University (ECSW2014-100614-222).

Infant behavioral assessment and intervention program in very low birth weight infants improves independency in mobility at preschool age

NARCIS (Netherlands)

Verkerk, Gijs; Jeukens-Visser, Martine; Koldewijn, Karen; van Wassenaer, Aleid; Houtzager, Bregje; Kok, Joke; Nollet, Frans

2011-01-01

To evaluate the effects of the Infant Behavioral Assessment and Intervention Program(©) (IBAIP) in very low birth weight infants on sensory processing and daily activities at preschool age. Follow-up of children included in a randomized controlled trial. Eighty-six infants were enrolled in

Reinforcement Behavior Therapy by Kindergarten Teachers on Preschool Children’s Aggression: A Randomized Controlled Trial

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Shahrzad Yektatalab

2016-01-01

Full Text Available Background: Aggression is a kind of behavior that causes damage or harm to others. The prevalence of aggression is 8–20% in 3–6 years old children. The present study aimed to assess the effect of training kindergarten teachers regarding reinforcement behavior therapy on preschoolers’ aggression. Methods: In this cluster randomized control trial, 14 out of 35 kindergarten and preschool centers of Mohr city, Iran, were chosen using random cluster sampling and then randomly assigned to an intervention and a control group. All 370 kindergarten and preschool children in 14 kindergarten were assessed by preschoolers’ aggression questionnaire and 60 children who obtained a minimum aggression score of 117.48 for girls and 125.77 for boys were randomly selected. The teachers in the intervention group participated in 4 educational sessions on behavior therapy and then practiced this technique under the supervision of the researcher for two months. Preschoolers’ aggression questionnaire was computed in both intervention and control groups before and after a two-month period. Results: The results demonstrated a significant statistical difference in the total aggression score (P=0.01, verbal (P=0.02 and physical (P=0.01 aggression subscales scores in the intervention group in comparison to the control group after the intervention. But the scores of relational aggression (P=0.09 and impulsive anger (P=0.08 subscales were not statistically different in the intervention group compared to the controls. Conclusion: This study highlighted the importance of teaching reinforcement behavior therapy by kindergarten teachers in decreasing verbal and physical aggression in preschoolers.

Supporting health care professionals to improve the processes of shared decision making and self-management in a web-based intervention: randomized controlled trial.

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Sassen, Barbara; Kok, Gerjo; Schepers, Jan; Vanhees, Luc

2014-10-21

Research to assess the effect of interventions to improve the processes of shared decision making and self-management directed at health care professionals is limited. Using the protocol of Intervention Mapping, a Web-based intervention directed at health care professionals was developed to complement and optimize health services in patient-centered care. The objective of the Web-based intervention was to increase health care professionals' intention and encouraging behavior toward patient self-management, following cardiovascular risk management guidelines. A randomized controlled trial was used to assess the effect of a theory-based intervention, using a pre-test and post-test design. The intervention website consisted of a module to help improve professionals' behavior, a module to increase patients' intention and risk-reduction behavior toward cardiovascular risk, and a parallel module with a support system for the health care professionals. Health care professionals (n=69) were recruited online and randomly allocated to the intervention group (n=26) or (waiting list) control group (n=43), and invited their patients to participate. The outcome was improved professional behavior toward health education, and was self-assessed through questionnaires based on the Theory of Planned Behavior. Social-cognitive determinants, intention and behavior were measured pre-intervention and at 1-year follow-up. The module to improve professionals' behavior was used by 45% (19/42) of the health care professionals in the intervention group. The module to support the health professional in encouraging behavior toward patients was used by 48% (20/42). The module to improve patients' risk-reduction behavior was provided to 44% (24/54) of patients. In 1 of every 5 patients, the guideline for cardiovascular risk management was used. The Web-based intervention was poorly used. In the intervention group, no differences in social-cognitive determinants, intention and behavior were found

Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

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Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

2015-01-01

To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

Use of the Tailored Activities Program to reduce neuropsychiatric behaviors in dementia: an Australian protocol for a randomized trial to evaluate its effectiveness.

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O'Connor, C M; Clemson, L; Brodaty, H; Jeon, Y H; Mioshi, E; Gitlin, L N

2014-05-01

Behavioral and psychological symptoms of dementia (BPSD) are often considered to be the greatest challenge in dementia care, leading to increased healthcare costs, caregiver burden, and placement into care facilities. With potential for pharmacological intervention to exacerbate behaviors or even lead to mortality, the development and rigorous testing of non-pharmacological interventions is vital. A pilot of the Tailored Activities Program (TAP) for reducing problem behaviors in people with dementia was conducted in the United States with promising results. This randomized trial will investigate the effectiveness of TAP for reducing the burden of BPSD on persons with dementia and family caregivers within an Australian population. This trial will also examine the cost-effectiveness and willingness to pay for TAP compared with a control group. This randomized trial aims to recruit 180 participant dyads of a person with dementia and their caregivers. Participants will have a diagnosis of dementia, exhibit behaviors as scored by the Neuropsychiatric Inventory, and the caregiver must have at least 7 h per week contact. Participants will be randomly allocated to intervention (TAP) or control (phone-based education sessions) groups, both provided by a trained occupational therapist. Primary outcome measure will be the revised Neuropsychiatric Inventory - Clinician rating scale (NPI-C) to measure BPSD exhibited by the person with dementia. This trial investigates the effectiveness and cost-effectiveness of TAP within an Australian population. Results will address a significant gap in the current Australian community-support base for people living with dementia and their caregivers.

Mid-way and post-intervention effects on potential determinants of physical activity and sedentary behavior, results of the HEIA study - a multi-component school-based randomized trial.

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Bergh, Ingunn H; Bjelland, Mona; Grydeland, May; Lien, Nanna; Andersen, Lene F; Klepp, Knut-Inge; Anderssen, Sigmund A; Ommundsen, Yngvar

2012-05-29

There is limited knowledge as to whether obesity prevention interventions are able to produce change in the determinants hypothesized to precede change in energy balance-related behaviors in young people. The aim of this study was to evaluate the effect of a multi-component intervention on a wide range of theoretically informed determinants of physical activity (PA) and sedentary behavior (SB). Moderation effects of gender, weight status and parental education level and whether the perceived intervention dose received influenced the effects were also explored. The HEIA study was a 20-month school-based, randomized controlled trial to promote healthy weight development. In total, 1418 11-year-olds participated at baseline and post-intervention assessment. Enjoyment, self-efficacy, perceived social support from parents, teachers and friends related to PA, perceived parental regulation of TV-viewing and computer/game-use and perceived social inclusion at schools were examined by covariance analyses to assess overall effects and moderation by gender, weight status and parental education, mid-way and post-intervention. Covariance analyses were also used to examine the role of intervention dose received on change in the determinants. At mid-way enjoyment (p = .03), perceived social support from teachers (p = .003) and self-efficacy (p = .05) were higher in the intervention group. Weight status moderated the effect on self-efficacy, with a positive effect observed among the normal weight only. At post-intervention results were sustained for social support from teachers (p = .001), while a negative effect was found for self-efficacy (p = .02). Weight status moderated the effect on enjoyment, with reduced enjoyment observed among the overweight. Moderation effects for parental education level were detected for perceived social support from parents and teachers. Finally, positive effects on several determinants were observed among those receiving a high

Text2Floss: the feasibility and acceptability of a text messaging intervention to improve oral health behavior and knowledge.

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Hashemian, Tony S; Kritz-Silverstein, Donna; Baker, Ryan

2015-01-01

Text messaging is useful for promoting numerous health-related behaviors. The Text2Floss Study examines the feasibility and utility of a 7-day text messaging intervention to improve oral health knowledge and behavior in mothers of young children. Mothers were recruited from a private practice and a community clinic. Of 156 mothers enrolled, 129 randomized into text (n = 60) and control groups (n = 69) completed the trial. Participants in the text group received text messages for 7 days, asking about flossing and presenting oral health information. Oral health behaviors and knowledge were surveyed pre- and post-intervention. At baseline, there were no differences between text and control group mothers in knowledge and behaviors (P > 0.10). Post-intervention, text group mothers flossed more (P = 0.01), had higher total (P = 0.0006) and specific (P Text messages were accepted and perceived as useful. Mothers receiving text messages improved their own oral health behaviors and knowledge as well as their behaviors regarding their children's oral health. Text messaging represents a viable method to improve oral health behaviors and knowledge. Its high acceptance may make it useful for preventing oral disease. © 2014 American Association of Public Health Dentistry.

Intervención para reducir riesgo en conductas sexuales de adolescentes: un ensayo aleatorizado y controlado Intervention to reduce adolescents’ sexual risk behaviors: a randomized controlled trial

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Esther C Gallegos

2008-02-01

Full Text Available OBJETIVO: Determinar la eficacia de una intervención conductual-educativa diseñada para disminuir las conductas sexuales de riesgo de VIH/SIDA y embarazos no planeados de adolescentes mexicanos. MATERIAL Y MÉTODOS: Ensayo controlado aleatorizado con cuatro seguimientos en un año; 832 adolescentes reclutados de escuelas preparatorias, entre 14 y 17 años, se asignaron aleatoriamente al grupo experimental o al control. La intervención, de seis hrs. de duración, aplicó estrategias de aprendizaje activo. El estudio se realizó en Monterrey, México, de 2002 a 2005. RESULTADOS: De acuerdo al análisis GEE, no hubo diferencia en las intenciones de tener relaciones sexuales, pero sí mayor nivel de intenciones de usar condón y anticonceptivos (diferencia de medias 0.15 y 0.16, IC 95% en el grupo experimental comparado con el control. Variables teoréticas como creencias sobre control fueron mediadoras de la intervención. CONCLUSIONES: La intervención conductual representa un importante esfuerzo en la promoción de conductas sexuales seguras en adolescentes mexicanos.OBJECTIVE: To test the efficacy of a behavioral intervention designed to decrease risk sexual behaviors for HIV/AIDS and unplanned pregnancies in Mexican adolescents. MATERIAL AND METHODS: Randomized controlled trial with four follow ups; 832 adolescents recruited from high schools, age 14-17, were randomly assigned to the experimental or control group. The six hour intervention used active learning strategies, and was delivered in two sessions on two consecutive Saturdays. The study was carried out in Monterrey, Mexico, 2002-2005. RESULTS: GEE analysis indicated no differences in sexual relationships’ intentions between the two conditions, however, the experimental group had higher intentions to use condoms and contraceptives (mean differences 0.15 and 0.16, CI 95% in the next three months, as compared with the control group. Theoretical variables, such as control beliefs, were

Interventions to Address Medical Conditions and Health-Risk Behaviors Among Persons With Serious Mental Illness: A Comprehensive Review

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McGinty, Emma E.; Baller, Julia; Azrin, Susan T.; Juliano-Bult, Denise; Daumit, Gail L.

2016-01-01

People with serious mental illness (SMI) have mortality rates 2 to 3 times higher than the overall US population, largely due to cardiovascular disease. The prevalence of cardiovascular risk factors such as obesity and diabetes mellitus and other conditions, such as HIV/AIDS, is heightened in this group. Based on the recommendations of a National Institute of Mental Health stakeholder meeting, we conducted a comprehensive review examining the strength of the evidence surrounding interventions to address major medical conditions and health-risk behaviors among persons with SMI. Peer-reviewed studies were identified using 4 major research databases. Randomized controlled trials and observational studies testing interventions to address medical conditions and risk behaviors among persons with schizophrenia and bipolar disorder between January 2000 and June 2014 were included. Information was abstracted from each study by 2 trained reviewers, who also rated study quality using a standard tool. Following individual study review, the quality of the evidence (high, medium, low) and the effectiveness of various interventions were synthesized. 108 studies were included. The majority of studies examined interventions to address overweight/obesity (n = 80). The strength of the evidence was high for 4 interventions: metformin and behavioral interventions had beneficial effects on weight loss; and bupropion and varenicline reduced tobacco smoking. The strength of the evidence was low for most other interventions reviewed. Future studies should test long-term interventions to cardiovascular risk factors and health-risk behaviors. In addition, future research should study implementation strategies to effectively translate efficacious interventions into real-world settings. PMID:26221050

Web-based interventions for weight loss and weight maintenance among rural midlife and older women: protocol for a randomized controlled trial

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Boeckner Linda S

2011-06-01

Full Text Available Abstract Background Weight loss is challenging and maintenance of weight loss is problematic among midlife and older rural women. Finding effective interventions using innovative delivery methods that can reach underserved and vulnerable populations of overweight and obese rural women is a public health challenge. Methods/Design This Women Weigh-In for Wellness (The WWW study randomized-controlled trial is designed to compare the effectiveness of theory-based behavior-change interventions using (1 website only, (2 website with peer-led support, or (3 website with professional email-counseling to facilitate initial weight loss (baseline to 6 months, guided continuing weight loss and maintenance (7-18 months and self-directed weight maintenance (19-30 months among rural women ages 45-69 with a BMI of 28-45. Recruitment efforts using local media will target 306 rural women who live within driving distance of a community college site where assessments will be conducted at baseline, 3, 6, 12, 18, 24 and 30 months by research nurses blinded to group assignments. Primary outcomes include changes in body weight, % weight loss, and eating and activity behavioral and biomarkers from baseline to each subsequent assessment. Secondary outcomes will be percentage of women achieving at least 5% and 10% weight loss without regain from baseline to 6, 18, and 30 months and achieving healthy eating and activity targets. Data analysis will use generalized estimating equations to analyze average change across groups and group differences in proportion of participants achieving target weight loss levels. Discussion The Women Weigh-In for Wellness study compares innovative web-based alternatives for providing lifestyle behavior-change interventions for promoting weight loss and weight maintenance among rural women. If effective, such interventions would offer potential for reducing overweight and obesity among a vulnerable, hard-to-reach, population of rural women

Feasibility study of a family- and school-based intervention for child behavior problems in Nepal.

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Adhikari, Ramesh P; Upadhaya, Nawaraj; Satinsky, Emily N; Burkey, Matthew D; Kohrt, Brandon A; Jordans, Mark J D

2018-01-01

This study evaluates the feasibility, acceptability, and outcomes of a combined school- and family-based intervention, delivered by psychosocial counselors, for children with behavior problems in rural Nepal. Forty-one children participated at baseline. Two students moved to another district, meaning 39 children, ages 6-15, participated at both baseline and follow-up. Pre-post evaluation was used to assess behavioral changes over a 4-month follow-up period (n = 39). The primary outcome measure was the Disruptive Behavior International Scale-Nepal version (DBIS-N). The secondary outcome scales included the Child Functional Impairment Scale and the Eyberg Child Behavior Inventory (ECBI). Twelve key informant interviews were conducted with community stakeholders, including teachers, parents, and community members, to assess stakeholders' perceptions of the intervention. The study found that children's behavior problems as assessed on the DBIS-N were significantly lower at follow-up (M = 13.0, SD = 6.4) than at baseline (M = 20.5, SD = 3.8), p behaviors among children and the implementation of new behavior management techniques both at home and in the classroom. Significant change in child outcome measures in this uncontrolled evaluation, alongside qualitative findings suggesting feasibility and acceptability, support moving toward a controlled trial to determine effectiveness.

Trial-to-trial reoptimization of motor behavior due to changes in task demands is limited.

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Orban de Xivry J-J

Full Text Available Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm was varied either on a trial-to-trial basis (random schedule or in blocks (blocked schedule. On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule.

Two-Year Findings from a National Effectiveness Trial: Effectiveness of Behavioral and Non-Behavioral Parenting Programs.

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Högström, Jens; Olofsson, Viveca; Özdemir, Metin; Enebrink, Pia; Stattin, Håkan

2017-04-01

Long-term follow-up studies of selective parent training (PT) programs are scarce, particularly in the case of effectiveness trials conducted within regular care settings. This study evaluated the 2-year effects of 4 programs: Comet, Incredible Years, Cope, and Connect and differences in the rate of change among programs were investigated using Latent Growth Modeling (LGM). Participants were parents who had sought help at 30 local service sector units (e.g., child psychiatric clinics and social services centers) for major problems in managing their children's externalizing behavior. Parents of 749 children (63 % boys) with moderate levels of externalizing behavior, aged 3-12, were randomized to one of the 4 PT programs. Assessments included parent-reported measures of child externalizing, hyperactivity and inattention, as well as parenting practices, sense of competence, and parents' stress and depressive symptoms. At 2-year follow-up, there were no differences in any of the child outcomes among the programs. All programs had reduced externalizing behaviors with large effect sizes (d = 1.21 to d = 1.32), and negative parenting practices with moderate to large effect sizes (d = 0.49 to d = 0.83). LGM analyses showed that the 2 behavioral programs, Comet and Incredible Years, produced more rapid reductions in externalizing behavior during the course of the intervention than the non-behavioral program, Connect. Connect, however, was the only program where children continued to improve after the intervention. Overall, the results indicate that the 4 programs were equally effective in a clinical setting, despite differences in their theoretical origin.

Effectiveness of web-based tailored advice on parents' child safety behaviors: randomized controlled trial.

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van Beelen, Mirjam Elisabeth Johanna; Beirens, Tinneke Monique Jozef; den Hertog, Paul; van Beeck, Eduard Ferdinand; Raat, Hein

2014-01-24

Injuries at home are a major cause of death, disability, and loss of quality of life among young children. Despite current safety education, required safety behavior of parents is often lacking. To prevent various childhood disorders, the application of Web-based tools has increased the effectiveness of health promotion efforts. Therefore, an intervention with Web-based, tailored, safety advice combined with personal counseling (E-Health4Uth home safety) was developed and applied. To evaluate the effect of E-Health4Uth home safety on parents' safety behaviors with regard to the prevention of falls, poisoning, drowning, and burns. A randomized controlled trial was conducted (2009-2011) among parents visiting well-baby clinics in the Netherlands. Parents were randomly assigned to the intervention group (E-Health4Uth home safety intervention) or to the control condition consisting of usual care. Parents in the intervention condition completed a Web-based safety behavior assessment questionnaire; the resulting tailored safety advice was discussed with their child health care professional at a well-baby visit (age approximately 11 months). Parents in the control condition received counseling using generic safety information leaflets at this well-baby visit. Parents' child safety behaviors were derived from self-report questionnaires at baseline (age 7 months) and at follow-up (age 17 months). Each specific safety behavior was classified as safe/unsafe and a total risk score was calculated. Logistic and linear regression analyses were used to reveal differences in safety behavior between the intervention and the control condition at follow-up. A total of 1292 parents (response rate 44.79%) were analyzed. At follow-up, parents in the intervention condition (n=643) showed significantly less unsafe behavior compared to parents in the control condition (n=649): top of staircase (23.91% vs. 32.19%; OR 0.65, 95% CI 0.50-0.85); bottom of staircase (63.53% vs. 71.94%; OR 0

Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial.

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Pagoto, S; Schneider, K L; Whited, M C; Oleski, J L; Merriam, P; Appelhans, B; Ma, Y; Olendzki, B; Waring, M E; Busch, A M; Lemon, S; Ockene, I; Crawford, S

2013-11-01

Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression before a lifestyle weight loss intervention improves both weight loss and depression. In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.9 (s.d.: 10.8) years) were randomized to brief behavior therapy for depression treatment followed by a lifestyle intervention (BA) or a lifestyle intervention only (LI). Follow-up occurred at 6 and 12 months. Main outcome measures included weight loss and depression symptoms. Intention-to-treat analyses revealed both conditions lost significant weight, but no differences between conditions in weight change at 6 months (BA=-3.0%, s.e.=-0.65%; LI=-3.7%, s.e.=0.63%; P=0.48) or 12 months (BA=-2.6%, s.e.=0.77%; LI=-3.1%, s.e.=0.74%; P=0.72). However, the BA condition evidenced significantly greater improvement in Beck Depression Inventory-II scores relative to the LI condition at both 6 months (BA mean change=-12.5, s.d.=0.85; LI mean change=-9.2, s.d.=0.80, P=0.005) and 12 months (BA mean change=-12.6, s.d.=0.97; LI mean change=-9.9, s.d.=0.93; P=0.045). Participants who experienced depression remission by 6 months (61.2%) lost greater weight (mean=-4.31%; s.e.=0.052) than those who did not (39.7%; mean=-2.47%, s.e.=0.53; P=.001). Adding behavior therapy to a lifestyle intervention results in greater depression remission but does not improve weight loss within 1 year. Improvement in depression is associated with greater weight loss.

Behavioral interventions for insomnia: Theory and practice.

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Sharma, Mahendra P; Andrade, Chittaranjan

2012-10-01

Insomnia is a general clinical term that refers to a difficulty in initiating or maintaining sleep. Insomnia is widely prevalent in the general population, especially in the elderly and in those with medical and psychiatric disorders. Hypnotic drug treatments of insomnia are effective but are associated with potential disadvantages. This article presents an overview of behavioral interventions for insomnia. Behavioral interventions for insomnia include relaxation training, stimulus control therapy, sleep restriction therapy, sleep hygiene, paradoxical intention therapy, cognitive restructuring, and other approaches. These are briefly explained. Research indicates that behavioral interventions are efficacious, effective, and likely cost-effective treatments for insomnia that yield reliable, robust, and long-term benefits in adults of all ages. Detailed guidance is provided for the practical management of patients with insomnia.

Evidence-Based Behavioral Interventions for Repetitive Behaviors in Autism

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Boyd, Brian A.; McDonough, Stephen G.; Bodfish, James W.

2012-01-01

Restricted and repetitive behaviors (RRBs) are a core symptom of autism spectrum disorders (ASD). There has been an increased research emphasis on repetitive behaviors; however, this research primarily has focused on phenomenology and mechanisms. Thus, the knowledge base on interventions is lagging behind other areas of research. The literature…

Efficacy Trial of a Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents: Effects at 1- and 2-Year Follow-Up

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Stice, Eric; Rohde, Paul; Gau, Jeff M.; Wade, Emily

2010-01-01

Objective: To evaluate the effects of a brief group cognitive-behavioral (CB) depression prevention program for high-risk adolescents with elevated depressive symptoms at 1- and 2-year follow-up. Method: In this indicated prevention trial, 341 at-risk youths were randomized to a group CB intervention, group supportive expressive intervention, CB…

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research.

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Poduska, Jeanne; Kellam, Sheppard; Brown, C Hendricks; Ford, Carla; Windham, Amy; Keegan, Natalie; Wang, Wei

2009-09-02

While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. NCT00257088.

Adherence to Behavioral Interventions for Stress Incontinence: Rates, Barriers, and Predictors

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Burgio, Kathryn L.; Goode, Patricia S.; Ye, Wen; Weidner, Alison C.; Lukacz, Emily S.; Jelovsek, John-Eric; Bradley, Catherine S.; Schaffer, Joseph; Hsu, Yvonne; Kenton, Kimberly; Spino, Cathie

2013-01-01

Background First-line conservative treatment for stress urinary incontinence (SUI) in women is behavioral intervention, including pelvic-floor muscle (PFM) exercise and bladder control strategies. Objective The purposes of this study were: (1) to describe adherence and barriers to exercise and bladder control strategy adherence and (2) to identify predictors of exercise adherence. Design This study was a planned secondary analysis of data from a multisite, randomized trial comparing intravaginal continence pessary, multicomponent behavioral therapy, and combined therapy in women with stress-predominant urinary incontinence (UI). Methods Data were analyzed from the groups who received behavioral intervention alone (n=146) or combined with continence pessary therapy (n=150). Adherence was measured during supervised treatment and at 3, 6, and 12 months post-randomization. Barriers to adherence were surveyed during treatment and at the 3-month time point. Regression analyses were performed to identify predictors of exercise adherence during supervised treatment and at the 3- and 12-month time points. Results During supervised treatment, ≥86% of the women exercised ≥5 days a week, and ≥80% performed at least 30 contractions on days they exercised. At 3, 6, and 12 months post-randomization, 95%, 88%, and 80% of women, respectively, indicated they were still performing PFM exercises. During supervised treatment and at 3 months post-randomization, ≥87% of the women reported using learned bladder control strategies to prevent SUI. In addition, the majority endorsed at least one barrier to PFM exercise, most commonly “trouble remembering to do exercises.” Predictors of exercise adherence changed over time. During supervised intervention, less frequent baseline UI and higher baseline 36-Item Short-Form Health Survey (SF-36) mental scores predicted exercise adherence. At 3 months post-randomization, women who dropped out of the study had weaker PFMs at baseline. At

Docosahexaenoic acid for reading, working memory and behavior in UK children aged 7-9: A randomized controlled trial for replication (the DOLAB II study).

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Montgomery, Paul; Spreckelsen, Thees F; Burton, Alice; Burton, Jennifer R; Richardson, Alexandra J

2018-01-01

Omega-3 fatty acids are central to brain-development of children. Evidence from clinical trials and systematic reviews demonstrates the potential of long-chain Omega-3 supplementation for learning and behavior. However, findings are inconclusive and in need of robust replication studies since such work is lacking. Replication of the 2012 DOLAB 1 study findings that a dietary supplementation with the long-chain omega-3 docosahexaenoic acid (DHA) had beneficial effects on the reading, working memory, and behavior of healthy schoolchildren. Parallel group, fixed-dose, randomized (minimization, 30% random element), double-blind, placebo-controlled trial (RCT). Mainstream primary schools (n = 84) from five counties in the UK in 2012-2015. Healthy children aged 7-9 underperforming in reading (reading, working memory, and behavior, parent-rated and as secondary outcome teacher-rated. 376 children were randomized. Reading, working memory, and behavior change scores showed no consistent differences between intervention and placebo group. Some behavioral subscales showed minor group differences. This RCT did not replicate results of the earlier DOLAB 1 study on the effectiveness of nutritional supplementation with DHA for learning and behavior. Possible reasons are discussed, particularly regarding the replication of complex interventions. www.controlled-trials.com (ISRCTN48803273) and protocols.io (https://dx.doi.org/10.17504/protocols.io.k8kczuw).

Project LifeSkills - a randomized controlled efficacy trial of a culturally tailored, empowerment-based, and group-delivered HIV prevention intervention for young transgender women: study protocol.

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Kuhns, Lisa M; Mimiaga, Matthew J; Reisner, Sari L; Biello, Katie; Garofalo, Robert

2017-09-16

Transgender women in the U.S. have an alarmingly high incidence rate of HIV infection; condomless anal and vaginal sex is the primary risk behavior driving transmission. Young transgender women are the subpopulation at the highest risk for HIV. Despite this, there are no published randomized controlled efficacy trials testing interventions to reduce sexual risk for HIV among this group. This paper describes the design of a group-based intervention trial to reduce sexual risk for HIV acquisition and transmission in young transgender women. This study, funded by the National Institutes of Health, is a randomized controlled trial of a culturally-specific, empowerment-based, and group-delivered six-session HIV prevention intervention, Project LifeSkills, among sexually active young transgender women, ages 16-29 years in Boston and Chicago. Participants are randomized (2:2:1) to either the LifeSkills intervention, standard of care only, or a diet and nutrition time- and attention-matched control. At enrollment, all participants receive standardized HIV pre- and post-test counseling and screening for HIV and urogenital gonorrhea and chlamydia infections. The primary outcome is difference in the rate of change in the number of self-reported condomless anal or vaginal sex acts during the prior 4-months, assessed at baseline, 4-, 8-, and 12-month follow-up visits. Behavioral interventions to reduce sexual risk for HIV acquisition and transmission are sorely needed for young transgender women. This study will provide evidence to determine feasibility and efficacy in one of the first rigorously designed trials for this population. ClinicalTrials.gov number, NCT01575938 , registered March 29, 2012.

Effectiveness of Social Media-based Interventions on Weight-related Behaviors and Body Weight Status: Review and Meta-analysis.

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An, Ruopeng; Ji, Mengmeng; Zhang, Sheng

2017-11-01

We reviewed scientific literature regarding the effectiveness of social media-based interventions about weight-related behaviors and body weight status. A keyword search were performed in May 2017 in the Clinical-Trials.gov, Cochrane Library, PsycINFO, PubMed, and Web of Science databases. We conducted a meta-analysis to estimate the pooled effect size of social media-based interventions on weight-related outcome measures. We identified 22 interventions from the keyword and reference search, including 12 randomized controlled trials, 6 pre-post studies and 3 cohort studies conducted in 9 countries during 2010-2016. The majority (N = 17) used Facebook, followed by Twitter (N = 4) and Instagram (N = 1). Intervention durations averaged 17.8 weeks with a mean sample size of 69. The meta-analysis showed that social media-based interventions were associated with a statistically significant, but clinically modest reduction of body weight by 1.01 kg, body mass index by 0.92 kg/m2, and waist circumstance by 2.65 cm, and an increase of daily number of steps taken by 1530. In the meta-regression there was no doseresponse effect with respect to intervention duration. The boom of social media provides an unprecedented opportunity to implement health promotion programs. Future interventions should make efforts to improve intervention scalability and effectiveness.

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

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Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

Effects of Exercise Interventions and Physical Activity Behavior on Cancer Related Cognitive Impairments: A Systematic Review

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Philipp Zimmer

2016-01-01

Full Text Available This systematic review analyzes current data on effects of exercise interventions and physical activity behavior on objective and subjective cancer related cognitive impairments (CRCI. Out of the 19 studies which met all inclusion criteria, five RCTs investigated rodents, whereas the other 14 trials explored humans and these included six RCTs, one controlled trial, two prospective noncontrolled trials, one case series, one observational study, and three cross-sectional studies. The results from animal models revealed positive effects of exercise during and after chemotherapy or radiation on structural alterations of the central nervous system, physiological as well as neuropsychological outcomes. The overall study quality in patient studies was poor. The current data on intervention studies showed preliminary positive effects of Asian-influenced movement programs (e.g., Yoga with benefits on self-perceived cognitive functions as well as a reduction of chronic inflammation for breast cancer patients in the aftercare. Exercise potentially contributes to the prevention and rehabilitation of CRCI. Additional RCTs with standardized neuropsychological assessments and controlling for potential confounders are needed to confirm and expand preliminary findings.

A randomized controlled trial of a telehealth parenting intervention: A mixed-disability trial.

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Hinton, Sharon; Sheffield, Jeanie; Sanders, Matthew R; Sofronoff, Kate

2017-06-01

The quality of parenting a child receives has a major impact on development, wellbeing and future life opportunities. This study examined the efficacy of Triple P Online - Disability (TPOL-D) a telehealth intervention for parents of children with a disability. Ninety-eight parents and carers of children aged 2-12 years diagnosed with a range of developmental, intellectual and physical disabilities were randomly assigned to either the intervention (51) or treatment-as-usual (47) control group. At post-intervention parents receiving the TPOL-D intervention demonstrated significant improvements in parenting practices and parenting self-efficacy, however a significant change in parent-reported child behavioral and emotional problems was not detected. At 3-month follow up intervention gains were maintained and/or enhanced. A significant decrease in parent-reported child behavioral and emotional problems was also detected at this time. The results indicate that TPOL-D is a promising telehealth intervention for a mixed-disability group. Copyright © 2017 Elsevier Ltd. All rights reserved.

Behavioral self-regulation for weight loss in young adults: a randomized controlled trial

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Wing Rena R

2009-02-01

Full Text Available Abstract Objective To determine the feasibility of recruiting and retaining young adults in a brief behavioral weight loss intervention tailored for this age group, and to assess the preliminary efficacy of an intervention that emphasizes daily self-weighing within the context of a self-regulation model. Methods Forty young adults (29.1 ± 3.9 years, range 21–35, average BMI of 33.36 ± 3.4 were randomized to one of two brief behavioral weight loss interventions: behavioral self-regulation (BSR or adapted standard behavioral treatment (SBT. Assessments were conducted at baseline, post-treatment (10 weeks, and follow-up (20 weeks. Intent to treat analyses were conducted using general linear modeling in SPSS version 14.0. Results Participants in both groups attended an average of 8.7 out of 10 group meetings, and retention rates were 93% and 88% for post-treatment and follow-up assessments, respectively. Both groups achieved significant weight losses at post-treatment (BSR = -6.4 kg (4.0; SBT = -6.2 kg (4.5 and follow-up (BSR = -6.6 kg (5.5; SBT = -5.8 kg (5.2, p p = .84. Across groups, there was a positive association between frequency of weighing at follow-up and overall weight change at follow-up (p = .01. Daily weighing was not associated with any adverse changes in psychological symptoms. Conclusion Young adults can be recruited and retained in a behavioral weight loss program tailored to their needs, and significant weight losses can be achieved and maintained through this brief intervention. Future research on the longer-term efficacy of a self-regulation approach using daily self-weighing for weight loss in this age group is warranted. Clinical Trials Registration # NCT00488228

Efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline in Twin Families (VIPP-Twins): Study protocol for a randomized controlled trial.

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Euser, Saskia; Bakermans-Kranenburg, Marian J; van den Bulk, Bianca G; Linting, Mariëlle; Damsteegt, Rani C; Vrijhof, Claudia I; van Wijk, Ilse C; Crone, Eveline A; van IJzendoorn, Marinus H

2016-06-06

Intervention programs with the aim of enhancing parenting quality have been found to be differentially effective in decreasing negative child outcomes such as externalizing behavioral problems, resulting in modest overall effect sizes. Here we present the protocol for a randomized controlled trial to examine the efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline for Twin Families (VIPP-Twins) on parenting quality and children's behavioral control and social competence. In addition, we aim to test the differential susceptibility theory; we examine differential efficacy of the intervention based on genetic make-up or temperament for both parents and children. Lastly, we explore neurobiological mechanisms underlying intervention effects on children's developmental outcomes. The original VIPP-SD was adapted for use in families with twins. The VIPP-Twins consists of five biweekly sessions in which the families are visited at home, parent-child interactions are videotaped and parents receive positive feedback on selected video fragments. Families (N = 225) with a same sex twin (mean age = 3.6 years) were recruited to participate in the study. The study consists of four assessments. After two baseline assessments in year 1 and year 2, a random 40 % of the sample will receive the VIPP-Twins program. The first post-test assessment will be carried out one month after the intervention and there will be a long term follow-up assessment two years after the intervention. Measures include observational assessments of parenting and children's social competence and behavioral control, and neurobiological assessments (i.e., hormonal functioning and neural (re-)activity). Results of the study will provide insights in the efficacy of the VIPP-Twins and reveal moderators and mediators of program efficacy. Overall the randomized controlled trial is an experimental test of the differential susceptibility theory. Dutch Trial

Determining intervention thresholds that change output behavior patterns

NARCIS (Netherlands)

Walrave, B.

2016-01-01

This paper details a semi-automated method that can calculate intervention thresholds—that is, the minimum required intervention sizes, over a given time frame, that result in a desired change in a system’s output behavior pattern. The method exploits key differences in atomic behavior profiles that

Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial.

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Poslawsky, Irina E; Naber, Fabiënne Ba; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

2015-07-01

In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child interaction and reducing the child's individual Autism Spectrum Disorder-related symptomatology in five home visits. VIPP-AUTI, as compared with usual care, demonstrated efficacy in reducing parental intrusiveness. Moreover, parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing. No significant group differences were found on other aspects of parent-child interaction or on child play behavior. At 3-months follow-up, intervention effects were found on child-initiated joint attention skills, not mediated by intervention effects on parenting. Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners. © The Author(s) 2014.

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

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Arthur V Peterson

Full Text Available The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention.High school smokers (n = 2,151 were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention or control (no intervention condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided.No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI = -3.4 to 5.8, p = .61, nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year.There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

Science.gov (United States)

Peterson, Arthur V; Marek, Patrick M; Kealey, Kathleen A; Bricker, Jonathan B; Ludman, Evette J; Heffner, Jaimee L

2016-01-01

The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long

Adherence to yoga and exercise interventions in a 6-month clinical trial

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Haas M

2007-11-01

Full Text Available Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and physical measures. Adherence to the intervention was obtained by class attendance and biweekly home practice logs. Results The drop-out rate was 13%. Among the completers of the two active interventions, average yoga class attendance was 77% and home practice occurred 64% of all days. Average exercise class attendance was 69% and home exercise occurred 54% of all days. There were no clear effects of adherence on the significant study outcomes (quality of life and physical measures. Class attendance was significantly correlated with baseline measures of depression, fatigue, and physical components of health-related quality of life. Significant differences in baseline measures were also found between study completers and drop-outs in the active interventions. Adherence was not related to age, gender, or education level. Conclusion Healthy seniors have good attendance at classes with a physically active intervention. Home practice takes place over half of the time. Decreased adherence to a potentially beneficial intervention has the potential to decrease the effect of the intervention in a clinical trial because subjects who might sustain the greatest benefit will receive a lower dose of the intervention and subjects with higher adherence rates may be functioning closer to maximum ability before the intervention. Strategies to maximize adherence among subjects at greater risk for low adherence will be important for future trials, especially complementary

The Effect of Emotional Focused Intervention on Spousal Emotional Abuse and Marital Satisfaction among Elderly Married Couples: A Randomized Controlled Trial

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Maryam Hazrati

2017-10-01

Full Text Available Background: This study examined the impacts of an Emotional Focused Intervention on emotional abuse behaviors and marital satisfaction among the elderly married couples. Methods: This randomized controlled trial study was carried out in Shiraz-Iran, during September 2013-2014. The elderly couples were invited to join an emotional focused intervention, following the advertisement and announcement on bulletin boards in the elderly day clinic centers and all governmental primary health care centers. Then, 57 couples (114 participants who were eligible for study were assigned in two groups by block randomization (29 in the experimental and 28 in the control group(.The couples in the experimental group received intervention twice a week for four weeks. Each session lasted 90 minutes. The control group didn’t receive any intervention and the subjects were put in the waiting list. The outcome measures were evaluated by Multidimensional Measure of Emotional Abuse Questionnaire (MMEAQ and Marital Satisfaction Questionnaire for Older People (MSQFOP. Repeated measurement ANOVA was used to detect any significant changes between groups in their mean scores of emotional abuse behaviors and marital satisfaction from pre- to post-test, and 3 months after the intervention. Analysis of data was performed using SPSS, version 19, and P≤0.05 was measured as significant. Results: The mean duration of marriage was 39.56±9.64 years. In the experimental group, the abusive behaviors decreased significantly (P<0.001 at times 2 and 3 compared with time 1, and marital satisfaction improved significantly only at time 3 (P<0.001. These differences were not significant in the control group. Conclusion: Emotion-focused couple-based interventions are helpful in reducing the spousal emotional abuse and improving marital satisfaction in among the elderly couples. Trial Registration Number: 2013111715426N1

Behavioral interventions for insomnia: Theory and practice

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Sharma, Mahendra P.; Andrade, Chittaranjan

2012-01-01

Insomnia is a general clinical term that refers to a difficulty in initiating or maintaining sleep. Insomnia is widely prevalent in the general population, especially in the elderly and in those with medical and psychiatric disorders. Hypnotic drug treatments of insomnia are effective but are associated with potential disadvantages. This article presents an overview of behavioral interventions for insomnia. Behavioral interventions for insomnia include relaxation training, stimulus control th...

A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

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Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

2014-05-24

The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

Efficacy of an adapted HIV and sexually transmitted infection prevention intervention for incarcerated women: a randomized controlled trial.

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Fogel, Catherine I; Crandell, Jamie L; Neevel, A M; Parker, Sharon D; Carry, Monique; White, Becky L; Fasula, Amy M; Herbst, Jeffrey H; Gelaude, Deborah J

2015-04-01

We tested the efficacy of an adapted evidence-based HIV-sexually transmitted infection (STI) behavioral intervention (Providing Opportunities for Women's Empowerment, Risk-Reduction, and Relationships, or POWER) among incarcerated women. We conducted a randomized trial with 521 women aged 18 to 60 years in 2 correctional facilities in North Carolina in 2010 and 2011. Intervention participants attended 8 POWER sessions; control participants received a single standard-of-care STI prevention session. We followed up at 3 and 6 months after release. We examined intervention efficacy with mixed-effects models. POWER participants reported fewer male sexual partners than did control participants at 3 months, although this finding did not reach statistical significance; at 6 months they reported significantly less vaginal intercourse without a condom outside of a monogamous relationship and more condom use with a main male partner. POWER participants also reported significantly fewer condom barriers, and greater HIV knowledge, health-protective communication, and tangible social support. The intervention had no significant effects on incident STIs. POWER is a behavioral intervention with potential to reduce risk of acquiring or transmitting HIV and STIs among incarcerated women returning to their communities.

Evaluation of ergonomic and education interventions to reduce occupational sitting in office-based university workers: study protocol for a randomized controlled trial.

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Radas, Antonia; Mackey, Martin; Leaver, Andrew; Bouvier, Anna-Louise; Chau, Josephine Y; Shirley, Debra; Bauman, Adrian

2013-10-12

Prolonged sitting is a specific occupational hazard in office workers. There is growing evidence that prolonged sitting is detrimental to metabolic health. The aim of this study is to determine whether providing office workers with education along with adjustable sit-stand workstations leads to reduction in sitting behavior. A randomized control trial (RCT) with three groups (one control group and two intervention groups) will be conducted in an office workplace setting. The education intervention group will receive an education package that encourages reduction in sitting behaviors. The sit-stand desk intervention group will receive the same education package along with an adjustable sit-stand desk. Participants will be included in the study if they are currently employed in a full-time academic or administrative role that involves greater than 15 hours per week or greater than 4 hours per day computer-based work. Baseline data will include participant's age, gender, weight, height, smoking habit, employment position, level of education, and baseline self-reported leisure time physical activity. The primary outcome is the average daily sedentary time during work hours, measured by an accelerometer. Participant recruitment commenced in March 2013 and will be completed by December 2013. This study will determine whether providing office workers with an adjustable sit-stand desk and individually targeted education, or education alone, is more effective in decreasing sitting behaviors than no intervention. Australian New Zealand Clinical Trials Registry: ACTRN12613000366752.

Effectiveness of the DECIDE Interventions on Shared Decision Making and Perceived Quality of Care in Behavioral Health With Multicultural Patients: A Randomized Clinical Trial.

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Alegria, Margarita; Nakash, Ora; Johnson, Kirsten; Ault-Brutus, Andrea; Carson, Nicholas; Fillbrunn, Mirko; Wang, Ye; Cheng, Alice; Harris, Treniece; Polo, Antonio; Lincoln, Alisa; Freeman, Elmer; Bostdorf, Benjamin; Rosenbaum, Marcos; Epelbaum, Claudia; LaRoche, Martin; Okpokwasili-Johnson, Ebele; Carrasco, MaJose; Shrout, Patrick E

2018-04-01

Few randomized clinical trials have been conducted with ethnic/racial minorities to improve shared decision making (SDM) and quality of care. To test the effectiveness of patient and clinician interventions to improve SDM and quality of care among an ethnically/racially diverse sample. This cross-level 2 × 2 randomized clinical trial included clinicians at level 2 and patients (nested within clinicians) at level 1 from 13 Massachusetts behavioral health clinics. Clinicians and patients were randomly selected at each site in a 1:1 ratio for each 2-person block. Clinicians were recruited starting September 1, 2013; patients, starting November 3, 2013. Final data were collected on September 30, 2016. Data were analyzed based on intention to treat. The clinician intervention consisted of a workshop and as many as 6 coaching telephone calls to promote communication and therapeutic alliance to improve SDM. The 3-session patient intervention sought to improve SDM and quality of care. The SDM was assessed by a blinded coder based on clinical recordings, patient perception of SDM and quality of care, and clinician perception of SDM. Of 312 randomized patients, 212 (67.9%) were female and 100 (32.1%) were male; mean (SD) age was 44.0 (15.0) years. Of 74 randomized clinicians, 56 (75.7%) were female and 18 (4.3%) were male; mean (SD) age was 39.8 (12.5) years. Patient-clinician pairs were assigned to 1 of the following 4 design arms: patient and clinician in the control condition (n = 72), patient in intervention and clinician in the control condition (n = 68), patient in the control condition and clinician in intervention (n = 83), or patient and clinician in intervention (n = 89). All pairs underwent analysis. The clinician intervention significantly increased SDM as rated by blinded coders using the 12-item Observing Patient Involvement in Shared Decision Making instrument (b = 4.52; SE = 2.17; P = .04; Cohen d = 0.29) but not as

Drinker Prototype Alteration and Cue Reminders as Strategies in a Tailored Web-Based Intervention Reducing Adults’ Alcohol Consumption: Randomized Controlled Trial

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2015-01-01

Background Excessive alcohol use is a prevalent and worldwide problem. Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality. Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking. Objective Through a Web-based randomized controlled trial, 2 strategies (ie, prototype alteration and cue reminders) within an existing online personalized feedback intervention (Drinktest) aimed to reduce adults’ excessive drinking. It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act. Methods Participants were recruited online and through printed materials. Excessive drinking adults (N=2634) were randomly assigned to 4 conditions: original Drinktest, Drinktest plus prototype alteration, Drinktest plus cue reminder, and Drinktest plus prototype alteration and cue reminder. Evaluation took place at 1-month posttest and 6-month follow-up. Differences in drinking behavior, intentions, and behavioral willingness (ie, primary outcomes) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method. Measures were based on self-reports. Results All conditions showed reductions in drinking behavior and willingness to drink, and increased intentions to reduce drinking. Prototype alteration (B=–0.15, Pprototypes. Thus, prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults, with an effect up to 6 months. Trial Registration Nederlands Trial Register (NTR): 4169; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 (Archived by WebCite at http://www.webcitation.org/6VD2jnxmB). PMID:25653199

Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

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Julie A Luker

2016-05-01

Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver

Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

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P R Srijithesh

2014-01-01

Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors: a cluster randomized trial.

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Verdurmen, Jacqueline E E; Koning, Ina M; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E

2014-03-01

To examine risk moderation of an alcohol intervention targeting parents and adolescents. A cluster randomized trial including 2937 Dutch early adolescents (m=12.68years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combined parent-student intervention, and control group. 152 classes of 19 high schools in The Netherlands (2006). Moderators at baseline (adolescent: gender, educational level and externalizing behavior; parent: educational level and heavy alcohol use) were used to examine the differential effects of the interventions on onset of (heavy) weekly drinking at 22-month follow-up. The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents, and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents (i.e. those attending lower levels of education and reporting higher levels of externalizing behavior). Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents, with an added effect on postponing heavy weekly drinking in high risk subgroups. Therefore, implementation of this intervention in the general population of schools in The Netherlands is advised. NTR649. Copyright © 2013 Elsevier Inc. All rights reserved.

A school-based intervention program in promoting leisure-time physical activity: trial protocol.

Science.gov (United States)

Kawabata, Masato; Chua, Khai Leng; Chatzisarantis, Nikos L D

2018-04-02

Regular participation in moderate-to-vigorous physical activity (MVPA) is important to manage obesity. Physical education (PE) is considered to play an important role in promoting lifelong participation in physical activity (PA) because it provides an existing network where cost-effective interventions can be implemented to produce sustainable change in health behavior. However, the association between compulsory school PA (e.g., PE lessons) and body composition levels has received mixed support in the literature. Therefore, the present study aimed to investigate whether a school-based intervention targeting salient PA benefits and barriers grounded on the theory of planned behavior would promote young people's participation in MVPA during leisure time and reduce body mass index (BMI) of overweight students. A total of 171 students from 3 secondary schools in Singapore underwent the control condition followed by the intervention condition. Both the conditions consisted of PE lessons twice per week over 4 weeks. In the control condition, PE teachers encouraged students to participate in PA during leisure time without providing persuasive message. While in the intervention condition, PE teachers delivered persuasive messages that targeted the salient benefits and barriers associated with PA to the students at the last 5 to 10 min of each PE lesson. PA levels over a week were measured objectively with wrist-mounted GENEActiv Original accelerometers and subjectively with self-reporting questionnaires three times (Baseline, Post 1, and Post 2) in each condition. Student's self-reported PA level was measured using the Leisure-Time Physical Activity Participation Questionnaire and the International Physical Activity Questionnaire, and their attitudes, intentions, subjective norms and perceived behavior control towards leisure-time PA were measured with a questionnaire based on the theory of planned behavior. Furthermore, students' intention, determination and

Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children.

Science.gov (United States)

Lepore, Stephen J; Winickoff, Jonathan P; Moughan, Beth; Bryant-Stephens, Tyra C; Taylor, Daniel R; Fleece, David; Davey, Adam; Nair, Uma S; Godfrey, Melissa; Collins, Bradley N

2013-08-30

Secondhand smoke exposure (SHSe) harms children's health, yet effective interventions to reduce child SHSe in the home and car have proven difficult to operationalize in pediatric practice. A multilevel intervention combining pediatric healthcare providers' advice with behavioral counseling and navigation to pharmacological cessation aids may improve SHSe control in pediatric populations. This trial uses a randomized, two-group design with three measurement periods: pre-intervention, end of treatment and 12-month follow-up. Smoking parents of children parents about child SHSe, advise about SHSe harms, and refer smokers to cessation resources. After receiving clinic intervention, eligible parents are randomized to receive: (a) a 3-month telephone-based behavioral counseling intervention designed to promote reduction in child SHSe, parent smoking cessation, and navigation to access nicotine replacement therapy or cessation medication or (b) an attention control nutrition education intervention. Healthcare providers and assessors are blind to group assignment. Cotinine is used to bioverify child SHSe (primary outcome) and parent quit status. This study tests an innovative multilevel approach to reducing child SHSe. The approach is sustainable, because clinics can easily integrate the tobacco intervention prompts related to "ask, advise, and refer" guidelines into electronic health records and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines. NCT01745393 (clinicaltrials.gov).

Randomized controlled trials of simulation-based interventions in Emergency Medicine: a methodological review.

Science.gov (United States)

Chauvin, Anthony; Truchot, Jennifer; Bafeta, Aida; Pateron, Dominique; Plaisance, Patrick; Yordanov, Youri

2018-04-01

The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

Driver behavior following an automatic steering intervention.

Science.gov (United States)

Fricke, Nicola; Griesche, Stefan; Schieben, Anna; Hesse, Tobias; Baumann, Martin

2015-10-01

The study investigated driver behavior toward an automatic steering intervention of a collision mitigation system. Forty participants were tested in a driving simulator and confronted with an inevitable collision. They performed a naïve drive and afterwards a repeated exposure in which they were told to hold the steering wheel loosely. In a third drive they experienced a false alarm situation. Data on driving behavior, i.e. steering and braking behavior as well as subjective data was assessed in the scenarios. Results showed that most participants held on to the steering wheel strongly or counter-steered during the system intervention during the first encounter. Moreover, subjective data collected after the first drive showed that the majority of drivers was not aware of the system intervention. Data from the repeated drive in which participants were instructed to hold the steering wheel loosely, led to significantly more participants holding the steering wheel loosely and thus complying with the instruction. This study seems to imply that without knowledge and information of the system about an upcoming intervention, the most prevalent driving behavior is a strong reaction with the steering wheel similar to an automatic steering reflex which decreases the system's effectiveness. Results of the second drive show some potential for countermeasures, such as informing drivers shortly before a system intervention in order to prevent inhibiting reactions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of Group Counseling Programs, Cognitive Behavioral Therapy, and Sports Intervention on Internet Addiction in East Asia: A Systematic Review and Meta-Analysis.

Science.gov (United States)

Liu, Jun; Nie, Jing; Wang, Yafeng

2017-11-28

To evaluate the effects of group counseling programs, cognitive behavioral therapy (CBT), and sports intervention on Internet addiction (IA), a systematic search in ten databases was performed to identify eligible studies without language restrictions up to January 2017. A meta-analysis and trial sequential analysis (TSA) was performed, respectively. A total of 58 randomized controlled trials (RCTs), which included 2871 participants, were incorporated into our meta-analysis. The results showed that group counseling programs, CBT, and sports intervention could significantly reduce IA levels (group counseling program: standardized mean difference (SMD), -1.37; 95% confidence interval (CI), -1.89 to -0.85; CBT: SMD, -1.88; 95% CI, -2.53 to -1.23; sports intervention: SMD, -1.70; 95% CI, -2.14 to -1.26). For group counseling programs, this treatment was more effective in four dimensions of IA, including time management, interpersonal and health issues, tolerance, and compulsive Internet use. For CBT, this treatment yielded a positive change in depression, anxiousness, aggressiveness, somatization, social insecurity, phobic anxiety, paranoid ideation, and psychoticism. For sports intervention, the significant effects were also observed in all dimensions of the IA scale. Each of group counseling programs, cognitive behavioral therapy, and sports intervention had a significant effect on IA and psychopathological symptoms. Sports intervention could improve withdrawal symptoms especially.

Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol

OpenAIRE

Tsai Midi; Jiang Yannan; Epstein Leonard; Foley Louise; Mhurchu Cliona; Maddison Ralph; Dewes Ofa; Heke Ihirangi

2011-01-01

Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family orie...

A Randomized, Controlled Trial of Behavioral Voice Therapy for Dysphonia Related to Prematurity of Birth.

Science.gov (United States)

Reynolds, Victoria; Meldrum, Suzanne; Simmer, Karen; Vijayasekaran, Shyan; French, Noel

2017-03-01

Dysphonia is a potential complication of prematurity. Preterm children may sustain iatrogenic laryngeal damage from medical intervention in the neonatal period, and further, adopt compensatory, maladaptive voicing behaviors. This pilot study aimed to evaluate the effects of a voice therapy protocol on voice quality in school-aged, very preterm (VP) children. Twenty-seven VP children with dysphonia were randomized to an immediate intervention group (n = 7) or a delayed-intervention, waiting list control group (n = 14). Following analysis of these data, a secondary analysis was conducted on the pooled intervention data (n = 21). Six participants did not complete the trial. Change to voice quality was measured via pre- and posttreatment assessments using the Consensus Auditory Perceptual Evaluation of Voice. The intervention group did not demonstrate statistically significant improvements in voice quality, whereas this was observed in the control group (P = 0.026). However, when intervention data were pooled including both the immediate and delayed groups following intervention, dysphonia severity was significantly lower (P = 0.026) in the treatment group. Dysphonia in most VP children in this cohort was persistent. These pilot data indicate that some participants experienced acceptable voice outcomes on spontaneous recovery, whereas others demonstrated a response to behavioral intervention. Further research is needed to identify the facilitators of and barriers to intervention success, and to predict those who may experience spontaneous recovery. Copyright © 2017 The Voice Foundation. All rights reserved.

Mid-way and post-intervention effects on potential determinants of physical activity and sedentary behavior, results of the HEIA study - a multi-component school-based randomized trial

Directory of Open Access Journals (Sweden)

Bergh Ingunn H

2012-05-01

Full Text Available Abstract Background There is limited knowledge as to whether obesity prevention interventions are able to produce change in the determinants hypothesized to precede change in energy balance-related behaviors in young people. The aim of this study was to evaluate the effect of a multi-component intervention on a wide range of theoretically informed determinants of physical activity (PA and sedentary behavior (SB. Moderation effects of gender, weight status and parental education level and whether the perceived intervention dose received influenced the effects were also explored. Methods The HEIA study was a 20-month school-based, randomized controlled trial to promote healthy weight development. In total, 1418 11-year-olds participated at baseline and post-intervention assessment. Enjoyment, self-efficacy, perceived social support from parents, teachers and friends related to PA, perceived parental regulation of TV-viewing and computer/game-use and perceived social inclusion at schools were examined by covariance analyses to assess overall effects and moderation by gender, weight status and parental education, mid-way and post-intervention. Covariance analyses were also used to examine the role of intervention dose received on change in the determinants. Results At mid-way enjoyment (p = .03, perceived social support from teachers (p = .003 and self-efficacy (p = .05 were higher in the intervention group. Weight status moderated the effect on self-efficacy, with a positive effect observed among the normal weight only. At post-intervention results were sustained for social support from teachers (p = .001, while a negative effect was found for self-efficacy (p = .02. Weight status moderated the effect on enjoyment, with reduced enjoyment observed among the overweight. Moderation effects for parental education level were detected for perceived social support from parents and teachers. Finally, positive effects on several

Walking the talk: the need for a trial registry for development interventions

DEFF Research Database (Denmark)

Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck

2011-01-01

Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim...... is weak as long as a trial registry of development interventions is not in place. Without a trial registry, the possibilities for data mining, created by analyses of multiple outcomes and subgroups, undermine internal validity. Drawing on experience from evidence-based medicine and recent examples from...

The impact of an exercise intervention on C - reactive protein during pregnancy: a randomized controlled trial.

Science.gov (United States)

Hawkins, Marquis; Braun, Barry; Marcus, Bess H; Stanek, Edward; Markenson, Glenn; Chasan-Taber, Lisa

2015-06-24

C-reactive protein (CRP) during pregnancy has been associated with adverse maternal outcomes such as preeclampsia and gestational diabetes mellitus. Randomized trials suggest that exercise programs may be associated with reductions in CRP in non-pregnant populations; however, such studies have not been conducted among pregnant women. The purpose of this study was to evaluate the impact of an individually-tailored motivationally-matched exercise intervention on CRP in pregnant women. The Behaviors Affecting Baby and You study was a randomized controlled trial of prenatal physical activity to prevent the development of gestational diabetes mellitus in women at increased risk. Women were randomized to either a 12-week exercise intervention (n = 84) or a comparison health and wellness intervention (n = 87). High sensitivity CRP (mg/dL) was measured using a commercial immunoassay kit. Physical activity was measured using the Pregnancy Physical Activity Questionnaire. Mixed model analyses were used to evaluate the impact of the intervention on change in CRP using an intent-to-treat approach. CRP decreased (-0.09 mg/dL, 95 % CI: -0.25, 0.07) from pre- to post-intervention in the exercise arm (p = 0.14) and increased (0.08 mg/dL, 95 % CI: -0.07, 0.24) (p = 0.64) in the health and wellness arm; however the between group difference was not statistically significant (p = 0.14). Findings did not differ according to ethnic group or pre-pregnancy body mass index. In a secondary analysis based on self-reported physical activity, women who decreased their time spent in sports/exercise experienced a mean increase in CRP (0.09 mg/dL, 95 % CI: -0.14, 0.33), whereas women who maintained or increased their sports/ exercise experienced a mean decrease in CRP (-0.08 mg/dL, 95 % CI: -0.23, 0.08) (p = 0.046). Findings from this randomized trial in an ethnically and socio-economically diverse population of pregnant women were consistent with a positive impact