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

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ClinicalTrials.gov Identifier: NCT03454997
Recruitment Status : Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. knowledge [ Time Frame: 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.

  2. self-efficacy [ Time Frame: 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.

  3. fidelity [ Time Frame: 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 :
  1. consumer dietary behavior [ Time Frame: 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.

  2. consumer physical activity [ Time Frame: change in minutes of self-reported physical activity between baseline and 6 months ]
    self-reported physical activity log

  3. consumer weight [ Time Frame: change in weight between baseline and 6 months ]
    weight measured in kilograms using a calibrated scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • 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)

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03454997     History of Changes
Other Study ID Numbers: IRB00156866
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will follow National Institute of Mental Health (NIMH) guidelines.
Supporting Materials: Study Protocol

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms