Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

通过改变习惯实现健康（WATCH）：针对不同青少年的基于接受的健康生活方式干预

基本信息

批准号：
10738846
负责人：
Stephanie Manasse
金额：
$ 71.47万
依托单位：
DREXEL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-09 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10738846
关键词：
19 year old Accelerometer Adherence Adolescent Adult Affect Aftercare Anorexia Behavior Therapy Behavioral Biological Blood Pressure Body Composition Body Weight decreased Body fat Body mass index Cardiometabolic Disease Clinical Trials Cues Demographic Factors Development Devices Diet Dietary intake Disinhibition Eating Behavior Eating Disorders Educational process of instructing Effectiveness Emotions Ethnic Origin Exhibits Feasibility Studies Female Adolescents Foundations Goals Habits Health Health behavior Hour Hybrids Hyperphagia Informal Social Control Institutional Review Boards Intervention Maintenance Manuals Measures Mediating Mental Depression Meta-Analysis Modality Non-Insulin-Dependent Diabetes Mellitus Obesity Outcome Outpatients Overweight Participant Patient Recruitments Perceived quality of life Persons Phase Physical activity Physiological Policies Population Heterogeneity Prevention Procedures Progress Reports Psychological Factors Quality of life Race Randomized Randomized, Controlled Trials Remote session Risk Factors Sleep Socioeconomic Status Teacher Professional Development Testing Therapeutic Intervention Time Time Study United States United States National Institutes of Health Weight Work acceptability and feasibility anxiety sensitivity behavioral outcome blood lipid blood pressure reduction cardiometabolism cardiovascular disorder risk chronic pain community clinic craving demographics dietary efficacy testing enhanced care ethnic minority experience feasibility testing flexibility follow-up girls healthy lifestyle high risk high risk sexual behavior improved individualized medicine innovation intervention effect lifestyle intervention mindfulness novel obesity treatment operation primary outcome psychologic psychological outcomes racial diversity racial minority recruit restraint secondary outcome sedentary lifestyle skills standard care success therapy development tool treatment comparison trial comparing weight loss intervention

项目摘要

ABSTRACT Overweight/obesity (OW/OB) affects 14 million adolescents in the United States, disproportionately affecting girls and racial/ethnic minorities, increasing their risk of cardiovascular disease and type 2 diabetes. Behavioral weight loss interventions are the foundation of obesity treatment modalities, yet many have led to limited weight loss and weight regain is common. Limited success in adolescent weight loss interventions may be attributed primarily to adolescents’ lack of self-regulation skills, which are essential for adhering to diet and physical activity goals. There is a critical need for development of interventions that teach self-regulation skills to adolescents in order to adapt to pervasive biological and environmental cues that are often experienced during weight loss. An innovative behavioral treatment, acceptance-based therapy (ABT), focuses on self- regulation skills and increasing mindfulness and tolerance of negative or uncomfortable emotions. ABT has demonstrated strong evidence as an effective weight loss strategy in adults. Our group utilized an adolescent- engaged approach to develop, implement, and test the feasibility and acceptability of an ABT weight loss intervention for adolescent girls with OW/OB. The feasibility study was a 6-month ABT behavioral weight loss intervention comprised of 15 in-person group sessions (90-minutes each) over a 6-month period led by an instructor trained in ABT. The feasibility study demonstrated strong acceptability among adolescent girls with OW/OB. The objective of this study, called the Wellness Achieved Through Changing Habits (WATCH) trial, is to test the efficacy of an ABT intervention versus an enhanced care (EC) intervention on markers of cardiometabolic health, health related behaviors, and psychological factors. During the R61 phase (year one), we will finalize all WATCH policies and procedures including clinical trials registration, manual of operations, IRB approvals, convening the DSMB board, and begin recruitment. We will also submit a NIH progress report on participant recruitment, demographics, and intervention fidelity. During the R33 phase (years 2-5), we propose a randomized controlled trial of 148 adolescent girls (≥40% racial/ethnic minorities) with OW/OB to test the hypothesis that those randomized to ABT (vs. EC) will have significantly decreased BMI z-score (primary outcome) and body fat, and improved blood pressure and blood lipids at post-treatment, 6-month follow-up, and 12-month follow-up. We also hypothesize that relative to EC intervention, ABT will significantly improve health-related behaviors and psychological factors. As an exploratory aim, we will examine the extent to which ABT’s effects on weight and body composition are mediated by improvements in behavioral and psychological factors, and identify key moderators of ABT intervention effects including baseline demographic and psychological factors. This study will yield a novel, obesity intervention tailored to the needs of adolescents with OW/OB by developing self-regulation skills and providing tools to promote cardiometabolic health.

抽象的超重/肥胖 (OW/OB) 影响着美国 1400 万青少年，影响尤为严重女孩和少数族裔，增加了患心血管疾病和 2 型糖尿病的风险。减肥干预措施是肥胖治疗方式的基础，但许多干预措施的效果有限青少年减肥干预措施的成功率可能有限。主要归因于青少年缺乏自我调节技能，而自我调节技能对于遵守饮食和饮食习惯至关重要迫切需要制定教授自我调节技能的干预措施。青少年以适应经常经历的普遍生物和环境线索在减肥过程中，一种创新的行为疗法——基于接受的疗法（ABT）侧重于自我调节。 ABT 具有调节技能以及增强对负面或不舒服情绪的正念和容忍度。强有力的证据表明，这是一种对成年人有效的减肥策略。开发、实施和测试 ABT 减肥的可行性和可接受性的参与方法对患有 OW/OB 的青春期女孩进行干预的可行性研究是一项为期 6 个月的 ABT 行为减肥。干预措施包括为期 6 个月的 15 次面对面小组会议（每次 90 分钟），由一名接受过 ABT 培训的教练的可行性研究表明，青少年女孩对 ABT 的接受度很高。 OW/OB。这项名为“通过改变习惯实现健康”(WATCH) 试验的目标是测试 ABT 干预与强化护理 (EC) 干预对以下标记物的疗效心脏代谢健康、健康相关行为和心理因素在 R61 阶段（第一年），我们将最终确定所有 WATCH 政策和程序，包括临床试验注册、操作手册、 IRB 批准，召集 DSMB 董事会，并开始招募。我们还将提交 NIH 进度报告。在 R33 阶段（第 2-5 年），我们对参与者招募、人口统计和干预保真度进行了研究。提议对 148 名患有 OW/OB 的青春期女孩（≥40% 种族/族裔）进行一项随机对照试验，以检验以下假设：随机接受 ABT（相对于 EC）的患者 BMI z 分数将显着降低（主要结果）和体脂，以及治疗后 6 个月时血压和血脂的改善我们还进行了 12 个月的随访，发现相对于 EC 干预，ABT 将显着增加。作为探索性目标，我们将检查改善与健康相关的行为和心理因素的程度。 ABT 对体重和身体成分的影响是通过行为和身体状况的改善来调节的心理因素，并确定 ABT 干预效果的关键调节因素，包括基线人口统计这项研究将针对青少年的需求提出一种新颖的肥胖干预措施。通过发展自我调节技能并提供促进心脏代谢健康的工具来与 OW/OB 合作。