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

Johns Hopkins University

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: organizational strategy meetings; Other: training including in-person and online; Other: performance coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT03454997

IRB00156866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Standard Implementation Intervention

Active Comparator group

Description:

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.

Treatment:

Other: training including in-person and online

Other: organizational strategy meetings

Enhanced Implementation Intervention

Active Comparator group

Description:

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.

Treatment:

Other: performance coaching

Other: training including in-person and online

Other: organizational strategy meetings