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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: training including in-person and online; Other: organizational strategy meetings; Other: performance coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Joseph Gennusa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Coaches -

• Adult staff or peer at community mental health program
• Willing and able to participate in training and delivery of intervention

Consumers-

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Implementation Intervention; The standard version 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.	Other: training including in-person and online; training, motivational interviewing practice; Other: organizational strategy meetings; meetings with leadership to optimize implementation of evidence-based practices
Active Comparator: Enhanced Implementation Intervention; The enhanced version 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 version will also include performance coaching.	Other: training including in-person and online; training, motivational interviewing practice; Other: organizational strategy meetings; meetings with leadership to optimize implementation of evidence-based practices; Other: performance coaching; to enhance ability to deliver the weight management intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of ACHIEVE Intervention Topics	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.	Baseline and 6 months
Self-efficacy to Deliver ACHIEVE Intervention	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.	Baseline and 6 months
Fidelity to ACHIEVE Intervention	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.	Baseline (after initial training) and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey	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.	Baseline and 6 months
Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey	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.	Baseline and 6 months
Consumer Sedentary Behavior	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.	Baseline and 6 months
Client Weight	Weight measured in kilograms (kg) using a calibrated scale and standardized procedures	Baseline and 6 months
Continued Site Implementation	Sites reported whether program was still being delivered six months after original study period.	12 months (6 months after original study period of Baseline to 6 months)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Gail Daumit, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: IRB00156866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will follow National Institute of Mental Health (NIMH) guidelines.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No