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

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-07-15 DOI:10.1016/j.cct.2024.107634

Stephanie M. Manasse , Jannah R. Moussaoui , Elizabeth W. Lampe , Kristal L. Brown , Fengqing Zhang , David M. Janicke , Leon McCrea , Michelle I. Cardel , Meghan L. Butryn

{"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":"Stephanie M. Manasse , Jannah R. Moussaoui , Elizabeth W. Lampe , Kristal L. Brown , Fengqing Zhang , David M. Janicke , Leon McCrea , Michelle I. Cardel , Meghan L. Butryn","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":"144 ","pages":"Article 107634"},"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.

查看原文本刊更多论文

评估以接受为基础的生活方式改变计划，以应对超重和肥胖少女的心血管疾病风险：随机对照试验方案。

背景：在青少年样本中，行为减肥干预只能达到有限的减肥效果，体重反弹的情况很常见。干预成功率有限的部分原因可能是青少年缺乏改变生活方式所必需的自我调节技能，以及采用 "一刀切 "的方法来减轻男孩和女孩的体重。传授自我调节技能的干预措施，如接纳疗法（ABT），以及针对不同性别所关注的问题而量身定制的干预措施，对于帮助青少年适应普遍存在的生物和环境对体重增加的影响至关重要：本试验测试了 ABT 干预对超重或肥胖（OW/OB）少女的心脏代谢健康、健康相关行为和心理因素的影响：研究将招募 14-19 岁的 OW/OB （体重指数：≥ 85 百分位数）女孩（N = 148；≥ 40% 的少数种族/民族）。参与者将被随机分配到两个为期 6 个月的干预措施中的一个，包括 18 个疗程的 ABT 或 9 个疗程的健康教育对照，后者是针对青少年 OW/OB 的标准护理的增强版，均由学士级干预专家领导：招募将于 2024 年 1 月至 2028 年 1 月在美国费城进行。将在基线、治疗中期、治疗后、6 个月随访和 12 个月随访时测量心血管代谢健康指标（脂肪率、血压、血脂）、健康相关行为（饮食摄入、体力活动、睡眠）和心理因素（生活质量、抑郁、饮食紊乱、心理弹性）：这项研究将为针对患有卵巢早衰/卵巢早衰的青春期女孩的需求而量身定制的新型干预措施提供有价值的信息，以解决自我调节和心脏代谢健康问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

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.