Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Fidelity to ACHIEVE Intervention
研究概览
简要总结
This is a pilot randomized clinical trial testing an implementation intervention to support delivery of a behavioral weight loss program at community mental health programs.
详细描述
This is a pilot randomized clinical trial testing an implementation intervention to support delivery of a behavioral weight loss program at community mental health programs. Investigators will conduct a pilot trial testing a standard and an enhanced implementation intervention. The evidenced based intervention investigators are basing the behavioral weight loss program on is ACHIEVE, and investigators are calling the translated weight loss program ACHIEVE-D. The standard version of the implementation intervention, which will train community mental health program staff to become ACHIEVE-D coaches and peers to become ACHIEVE-D peer-leaders, will include in-person and online training and avatar-assisted motivational interviewing practice, as well as organizational strategy meetings. The enhanced implementation intervention will include all of these strategies + performance coaching for ACHIEVE-D coaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and older
- •Enrolled in a psychiatric rehabilitation program
- •BMI ≥ 25 kg/m2
- •Willing to make changes in diet and exercise to lose weight
- •Willing to attend the ACHIEVE group sessions virtually or in-person at least once per week
- •Ability to use a computer or tablet
- •Competent and willing to give informed oral consent
- •Completion of baseline data collection
排除标准
- •Any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which dietary change/physical activity/weight loss may be contraindicated e.g., Lung disease requiring supplemental oxygen Liver failure History of anorexia nervosa or bulimia Stage V kidney disease on dialysis Cardiovascular event in the last 6 months including unstable angina, myocardial infarction, congestive heart failure, transient ischemic attack, or stroke
- •Insulin dependent diabetes
- •Inability to walk unassisted (e.g., uses a cane, walker, etc)
- •Pregnant, breastfeeding, or planning a pregnancy during study period
- •Prior or planned bariatric surgery
- •Use of a prescription anti-obesity medication or over-the-counter orlistat within the past 3 months
- •Self-reported weight loss of >20 lbs in the last 3 months
- •Active substance use disorder, alcohol use disorder, or problem drinking (more than 14 drinks per week for women, more than 21 drinks per week for men)
- •Planning to leave mental health program or move out of geographic area within 12 months
- •Weight greater than 440 pounds (so as not to exceed capacity of study scale)
- •Investigator judgment (e.g., for concerns over safety, adherence or follow-up)
结局指标
主要结局
Fidelity to ACHIEVE Intervention
时间窗: Baseline (after initial training) and 6 months
Fidelity to the intervention using a tool rating minimal competencies in delivering the intervention. This is a closed ended rating form where coaches are observed and rated. Total scores ranged from 0 to 34 with higher scores indicating higher fidelity.
Knowledge of ACHIEVE Intervention Topics
时间窗: Baseline and 6 months
Knowledge to deliver the intervention using a measure developed by the study team with questions related to weight management and group exercise, 22 questions, each either correct or incorrect. Score range 0-22 will reflect number of questions answered correctly. Higher score indicates better performance.
Self-efficacy to Deliver ACHIEVE Intervention
时间窗: Baseline and 6 months
Self-efficacy to deliver the intervention using a measure developed by the study team with a score range of 1-10. A higher score is better and indicates higher confidence to deliver the intervention.
次要结局
- Continued Site Implementation(12 months (6 months after original study period of Baseline to 6 months))
- Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey(Baseline and 6 months)
- Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey(Baseline and 6 months)
- Consumer Sedentary Behavior(Baseline and 6 months)
- Client Weight(Baseline and 6 months)