Status:
COMPLETED
Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Lead Sponsor:
Johns Hopkins University
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Coaches -
- Adult staff or peer at community mental health program
- Willing and able to participate in training and delivery of intervention
- Consumers-
- 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
- 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)
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03454997
Start Date
March 16 2021
End Date
March 30 2023
Last Update
August 20 2025
Active Locations (1)
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1
Joseph Gennusa
Baltimore, Maryland, United States, 21224