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

NCT03454997 | Completed Results

• 1 other identifier: IRB00156866
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Continued Site Implementation

  12 months (6 months after original study period of Baseline to 6 months)

Study Arms (2)

Standard Implementation Intervention

ACTIVE COMPARATOR

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; Other: organizational strategy meetings

Enhanced Implementation Intervention

ACTIVE COMPARATOR

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; Other: organizational strategy meetings; Other: performance coaching

Interventions

training including in-person and online OTHER

training, motivational interviewing practice

Enhanced Implementation Intervention; Standard Implementation Intervention

organizational strategy meetings OTHER

meetings with leadership to optimize implementation of evidence-based practices

Enhanced Implementation Intervention; Standard Implementation Intervention

performance coaching OTHER

to enhance ability to deliver the weight management intervention

Enhanced Implementation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Joseph Gennusa

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Jerome GJ, Goldsholl S, Dalcin AT, Gennusa Rd JV, Yuan CT, Brown K, Fink T, Minahan E, Wang NY, Daumit GL, Gudzune K. Comparing Implementation Strategies for an Evidence-Based Weight Management Program Delivered in Community Mental Health Programs: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 May 10;12:e45802. doi: 10.2196/45802.

  PMID: 37163331 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gail Daumit MD, MHS
• Organization: Johns Hopkins University School of Medicine

gdaumit@jhmi.edu

410-614-6460

Study Officials

• Gail Daumit

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 6, 2018
• Study Start: March 16, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 30, 2023
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)