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

Completed · Not applicable

Conditions studied: Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT03454997

Run by

Johns Hopkins University

People needed

92

Starts

2021-03-16

Expected to finish

2023-03-30

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• Joseph Gennusa — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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