N/A
Completed N=92
Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
Overweight and Obesity
Source: ClinicalTrials.gov NCT03454997 ↗
Enrolled (actual)
92
Serious AEs
8.3%
Results posted
Aug 2025
Primary outcomePrimary: Knowledge of ACHIEVE Intervention Topics — 16.1; 13.3; 19.9; 20.5 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge of ACHIEVE Intervention Topics |
16.1; 13.3; 19.9; 20.5 | — |
| PRIMARY Self-efficacy to Deliver ACHIEVE Intervention |
8.9; 9.3; 8.4; 8.9; 9.0; 9.5 | — |
| PRIMARY Fidelity to ACHIEVE Intervention |
29.5; 25.5; 29.9; 30.7 | — |
| SECONDARY Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey |
20.7; 20.9; 15.0; 20.0 | — |
| SECONDARY Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey |
3.4; 4.5; 3.8; 4.7 | — |
| SECONDARY Consumer Sedentary Behavior |
8.9; 11.0; 7.9; 8.5 | — |
| SECONDARY Client Weight |
111.9; 114.8; 106.5; 112.7 | — |
| SECONDARY Continued Site Implementation |
4; 0; 1; 3 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03454997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.