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

Overweight and Obesity Clinical Trial

— ACHIEVE-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454997
• Other study ID #: IRB00156866
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• training including in-person and online
training, motivational interviewing practice
• organizational strategy meetings
meetings with leadership to optimize implementation of evidence-based practices
• performance coaching
to enhance ability to deliver the weight management intervention

Locations

Country	Name	City	State
United States	Joseph Gennusa	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge	knowledge to deliver the intervention using a measure we will develop with questions related to weight management and group exercise, estimated 29 questions, each either correct or incorrect. This is a pilot study and this measure will be finalized during the planning phase of the study.	change in knowledge between baseline and 6 months
Primary	self-efficacy	self-efficacy to deliver the intervention using a measure we will develop based on Bandura's measurement principles, estimated 37 questions each one with score 1-10. This is a pilot study and this measure will be finalized during the planning phase of the study.	change in self-efficacy between baseline and 6 months
Primary	fidelity	fidelity to the intervention using a tool rating minimal competencies in delivering the intervention. This is a closed ended rating form where coaches are observed and rated. There are approximately 30 items. Ratings are either yes/no or on a 5 item scale.This is a pilot study and this measure will be finalized during the planning phase of the study.	change in fidelity between baseline (after initial training) and 6 months
Secondary	consumer dietary behavior	standard screeners for fat/fruit/vegetable/fiber/sugar-sweetened beverages. These will include the 1. Sugar Sweetened Beverage 7 items (from the Center for Disease Control (CDC) Behavioral Risk Factor and Surveillance System), and 2. Block screeners for fat/fruit/vegetable/fiber.	change in dietary behavior between baseline and 6 months
Secondary	consumer sedentary behavior	CARDIA-EARLY Sedentary Behavior questionnaire. We will use this 12-item sedentary behavior measure which separately estimates the amount of time (None,15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours or more) spent on six categories of sedentary behaviors for an average weekday or weekend day. These responses are then summed to create separate estimates of average weekday and weekend day total sedentary behavior. For a weekly estimate of sedentary behavior these scores are weighted and then summed for a total score which ranges from 0 to 168 hours and an average day estimate can be calculated by dividing this weekly estimate by 7 (0 to 24). For all scoring a higher score indicates more sedentary activity.	change in self-reported sedentary behavior between baseline and 6 months
Secondary	consumer weight	weight measured in kilograms using a calibrated scale	change in weight between baseline and 6 months
Secondary	continued implementation	Interviews will be used to understand if/how the organization has continued implementing the ACHIEVE curriculum, and if so, which aspects, any adaptations, and if training was provided.	administered six months post project