Back to resultsAdapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs (ACHIEVE-D)
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
training including in-person and online
organizational strategy meetings
performance coaching
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
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)
Sites / Locations
- Joseph Gennusa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Implementation Intervention
Enhanced Implementation Intervention
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
consumer weight
weight measured in kilograms using a calibrated scale
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.
Full Information
NCT ID
NCT03454997
First Posted
February 13, 2018
Last Updated
May 25, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03454997
Brief Title
Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Acronym
ACHIEVE-D
Official Title
Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Implementation Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Enhanced Implementation Intervention
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
training including in-person and online
Intervention Description
training, motivational interviewing practice
Intervention Type
Other
Intervention Name(s)
organizational strategy meetings
Intervention Description
meetings with leadership to optimize implementation of evidence-based practices
Intervention Type
Other
Intervention Name(s)
performance coaching
Intervention Description
to enhance ability to deliver the weight management intervention
Primary Outcome Measure Information:
Title
knowledge
Description
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.
Time Frame
change in knowledge between baseline and 6 months
Title
self-efficacy
Description
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.
Time Frame
change in self-efficacy between baseline and 6 months
Title
fidelity
Description
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.
Time Frame
change in fidelity between baseline (after initial training) and 6 months
Secondary Outcome Measure Information:
Title
consumer dietary behavior
Description
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.
Time Frame
change in dietary behavior between baseline and 6 months
Title
consumer sedentary behavior
Description
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.
Time Frame
change in self-reported sedentary behavior between baseline and 6 months
Title
consumer weight
Description
weight measured in kilograms using a calibrated scale
Time Frame
change in weight between baseline and 6 months
Title
continued implementation
Description
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.
Time Frame
administered six months post project
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Daumit
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joseph Gennusa
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will follow National Institute of Mental Health (NIMH) guidelines.
Learn more about this trial
Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
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