Evaluating an acceptance-based lifestyle modification program to address cardiovascular disease risk among adolescent girls with overweight and obesity: Protocol for a randomized controlled trial
{"title":"Evaluating an acceptance-based lifestyle modification program to address cardiovascular disease risk among adolescent girls with overweight and obesity: Protocol for a randomized controlled trial","authors":"","doi":"10.1016/j.cct.2024.107634","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Behavioral weight loss interventions achieve only limited weight loss in adolescent samples and weight regain is common. This limited intervention success may be attributed, in part, to adolescents' lack of self-regulation skills essential for lifestyle modification and use of a one-size fits-all approach to produce weight loss in boys and girls. Interventions which teach self-regulation skills, such as Acceptance-Based Therapy (ABT), and are tailored to meet gender-specific concerns, are critical to help adolescents adapt to pervasive biological and environmental influences toward weight gain.</p></div><div><h3>Objective</h3><p>This trial tests the effect of an ABT intervention on cardiometabolic health, health-related behaviors, and psychological factors among adolescent girls with overweight or obesity (OW/OB).</p></div><div><h3>Methods</h3><p>Girls 14–19 years (<em>N</em> = 148; ≥ 40% racial/ethnic minorities) with OW/OB (BMI: ≥ 85th percentile) will be enrolled in the study. Participants will be randomized to one of two 6-month interventions, consisting of either 18 sessions of ABT or 9 sessions of a health education control, an augmented version of standard care for adolescent OW/OB, both led by bachelor's level interventionists.</p></div><div><h3>Results</h3><p>Recruitment is taking place in Philadelphia, <strong>USA</strong>, from January 2024 to January 2028. Cardiometabolic health markers (adiposity; blood pressure; blood lipids), health-related behaviors (dietary intake; physical activity; sleep), and psychological factors (quality of life; depression; disordered eating; psychological flexibility) will be measured at baseline, mid-treatment, post-treatment, 6-month follow-up, and 12-month follow-up.</p></div><div><h3>Conclusions</h3><p>This study will provide valuable information on a novel intervention tailored to the needs of adolescent girls with OW/OB to address self-regulation and cardiometabolic health.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002179","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Behavioral weight loss interventions achieve only limited weight loss in adolescent samples and weight regain is common. This limited intervention success may be attributed, in part, to adolescents' lack of self-regulation skills essential for lifestyle modification and use of a one-size fits-all approach to produce weight loss in boys and girls. Interventions which teach self-regulation skills, such as Acceptance-Based Therapy (ABT), and are tailored to meet gender-specific concerns, are critical to help adolescents adapt to pervasive biological and environmental influences toward weight gain.
Objective
This trial tests the effect of an ABT intervention on cardiometabolic health, health-related behaviors, and psychological factors among adolescent girls with overweight or obesity (OW/OB).
Methods
Girls 14–19 years (N = 148; ≥ 40% racial/ethnic minorities) with OW/OB (BMI: ≥ 85th percentile) will be enrolled in the study. Participants will be randomized to one of two 6-month interventions, consisting of either 18 sessions of ABT or 9 sessions of a health education control, an augmented version of standard care for adolescent OW/OB, both led by bachelor's level interventionists.
Results
Recruitment is taking place in Philadelphia, USA, from January 2024 to January 2028. Cardiometabolic health markers (adiposity; blood pressure; blood lipids), health-related behaviors (dietary intake; physical activity; sleep), and psychological factors (quality of life; depression; disordered eating; psychological flexibility) will be measured at baseline, mid-treatment, post-treatment, 6-month follow-up, and 12-month follow-up.
Conclusions
This study will provide valuable information on a novel intervention tailored to the needs of adolescent girls with OW/OB to address self-regulation and cardiometabolic health.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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