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

NCT ID: NCT03454997

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2023-03-30

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

training including in-person and online

Intervention Type: OTHER

training, motivational interviewing practice

organizational strategy meetings

Intervention Type: OTHER

meetings with leadership to optimize implementation of evidence-based practices

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.

Group Type: ACTIVE_COMPARATOR

training including in-person and online

Intervention Type: OTHER

training, motivational interviewing practice

organizational strategy meetings

Intervention Type: OTHER

meetings with leadership to optimize implementation of evidence-based practices

performance coaching

Intervention Type: OTHER

to enhance ability to deliver the weight management intervention

Interventions

training including in-person and online

training, motivational interviewing practice

Intervention Type: OTHER

organizational strategy meetings

meetings with leadership to optimize implementation of evidence-based practices

Intervention Type: OTHER

performance coaching

to enhance ability to deliver the weight management intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Daumit

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Joseph Gennusa

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37163331 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00156866

Identifier Type: -

Identifier Source: org_study_id