Clinical trial NCT03454997: Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Official title: Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: knowledge
timeFrame: change in knowledge between baseline and 6 months
measure: self-efficacy
timeFrame: change in self-efficacy between baseline and 6 months
measure: fidelity
timeFrame: change in fidelity between baseline (after initial training) and 6 months
Secondary outcomes:
measure: consumer dietary behavior
timeFrame: change in dietary behavior between baseline and 6 months
measure: consumer sedentary behavior
timeFrame: change in self-reported sedentary behavior between baseline and 6 months
measure: consumer weight
timeFrame: change in weight between baseline and 6 months
measure: continued implementation
timeFrame: administered six months post project
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Joseph Gennusa
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gail Daumit
role: PRINCIPAL_INVESTIGATOR
References: