Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- Johns Hopkins University
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Fidelity to ACHIEVE Intervention
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Fidelity to ACHIEVE Intervention
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)