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

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03454997

Collaborator

(none)

Enrollment

Location

Arms

20.5

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Other: training including in-person and online Other: organizational strategy meetings Other: performance coaching	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Implementation Intervention 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.	Other: training including in-person and online training, motivational interviewing practice Other: organizational strategy meetings meetings with leadership to optimize implementation of evidence-based practices
Active Comparator: Enhanced Implementation Intervention 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.	Other: training including in-person and online training, motivational interviewing practice Other: organizational strategy meetings meetings with leadership to optimize implementation of evidence-based practices Other: performance coaching to enhance ability to deliver the weight management intervention

Arm

Intervention/Treatment

Active Comparator: Standard Implementation Intervention

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.

Other: training including in-person and online

training, motivational interviewing practice

Other: organizational strategy meetings

meetings with leadership to optimize implementation of evidence-based practices

Active Comparator: Enhanced Implementation Intervention

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.

Other: training including in-person and online

training, motivational interviewing practice

Other: organizational strategy meetings

meetings with leadership to optimize implementation of evidence-based practices

Other: performance coaching

to enhance ability to deliver the weight management intervention

Outcome Measures

Primary Outcome Measures

knowledge [change in knowledge between baseline and 6 months]
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.
self-efficacy [change in self-efficacy between baseline and 6 months]
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.
fidelity [change in fidelity between baseline (after initial training) and 6 months]
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.

Secondary Outcome Measures

consumer dietary behavior [change in dietary behavior between baseline and 6 months]
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.
consumer physical activity [change in minutes of self-reported physical activity between baseline and 6 months]
self-reported physical activity log
consumer weight [change in weight between baseline and 6 months]
weight measured in kilograms using a calibrated scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Coaches - adult staff or peer at community mental health program, willing and able to participate in training and delivery of intervention

Consumers-

Inclusion Criteria:

consumer in participating mental health program
18 years or older
overweight or obese. BMI>= 25.0 kg/m2.
willing to participate

Exclusion Criteria:

Inability to safely participate in exercise class.
Contraindication to weight loss (e.g., anorexia)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joseph Gennusa	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Gail Daumit, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT03454997

Other Study ID Numbers:

IRB00156866

First Posted:

Mar 6, 2018

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Mar 10, 2022