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Completed

NCT Number: NCT03454997

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joseph Gennusa

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

training including in-person and online

Other

training, motivational interviewing practice

organizational strategy meetings

Other

meetings with leadership to optimize implementation of evidence-based practices

Performance Coaching

Other

to enhance ability to deliver the weight management intervention

Primary outcomes

  1. Knowledge of ACHIEVE Intervention Topics

    Time frame: Baseline and 6 months

    Knowledge to deliver the intervention using a measure developed by the study team with questions related to weight management and group exercise, 22 questions, each either correct or incorrect. Score range 0-22 will reflect number of questions answered correctly. Higher score indicates better performance.

  2. Self-efficacy to Deliver ACHIEVE Intervention

    Time frame: Baseline and 6 months

    Self-efficacy to deliver the intervention using a measure developed by the study team with a score range of 1-10. A higher score is better and indicates higher confidence to deliver the intervention.

  3. Fidelity to ACHIEVE Intervention

    Time frame: 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. Total scores ranged from 0 to 34 with higher scores indicating higher fidelity.

Secondary outcomes

  1. Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey

    Time frame: Baseline and 6 months

    Participants self reported responses to the NHIS five factor dietary screener. The potential values range from 0 servings to no upper limit with higher numbers indicating higher amounts of food product consumed.

  2. Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey

    Time frame: Baseline and 6 months

    Participants self reported responses to the NHIS five factor dietary screener. The potential values range from 0 servings to no upper limit with higher numbers indicating higher amounts of food product consumed.

  3. Consumer Sedentary Behavior

    Time frame: Baseline and 6 months

    CARDIA-EARLY Sedentary Behavior questionnaire. 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. 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 is calculated by dividing this weekly estimate by 7 (0 to 24).

    Scores reported below reflect the average day estimate of sedentary behavior with a possible score range of 0 to 24 hours. For all scoring a higher score indicates more sedentary activity completed in the day. Higher score is worse.

  4. Client Weight

    Time frame: Baseline and 6 months

    Weight measured in kilograms (kg) using a calibrated scale and standardized procedures

  5. Continued Site Implementation

    Time frame: 12 months (6 months after original study period of Baseline to 6 months)

    Sites reported whether program was still being delivered six months after original study period.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: ACHIEVE-D

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2018
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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