Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs

Not Applicable

Completed

Conditions: Overweight and Obesity

Registration Number: NCT03454997

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

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)
Investigator judgment (e.g., for concerns over safety, adherence or follow-up)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fidelity to ACHIEVE Intervention	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	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	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 Outcome Measures

Name	Time	Method
Continued Site Implementation	12 months (6 months after original study period of Baseline to 6 months)	Sites reported whether program was still being delivered six months after original study period.
Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey	Baseline and 6 months	Participants self reported responses to the NHIS five factor dietary screener. The potential values range from 0 servings to no upper limit with higher numbers indicating higher amounts of food product consumed.
Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey	Baseline and 6 months	Participants self reported responses to the NHIS five factor dietary screener. The potential values range from 0 servings to no upper limit with higher numbers indicating higher amounts of food product consumed.
Consumer Sedentary Behavior	Baseline and 6 months	CARDIA-EARLY Sedentary Behavior questionnaire. 12-item sedentary behavior measure which separately estimates the amount of time (None,15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours or more) spent on six categories of sedentary behaviors for an average weekday or weekend day. These responses are then summed to create separate estimates of average weekday and weekend day total sedentary behavior. A weekly estimate of sedentary behavior these scores are weighted and then summed for a total score which ranges from 0 to 168 hours and an average day estimate is calculated by dividing this weekly estimate by 7 (0 to 24). Scores reported below reflect the average day estimate of sedentary behavior with a possible score range of 0 to 24 hours. For all scoring a higher score indicates more sedentary activity completed in the day. Higher score is worse.
Client Weight	Baseline and 6 months	Weight measured in kilograms (kg) using a calibrated scale and standardized procedures