Overweight and ObesityACHIEVE-DNCT03454997
Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
A study testing training including in-person and online, organizational strategy meetings and performance coaching in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- training including in-person and online, organizational strategy meetings and performance coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- training including in-person and online, organizational strategy meetings, performance coaching
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training including in-person and onlineOther
training, motivational interviewing practice
organizational strategy meetingsOther
meetings with leadership to optimize implementation of evidence-based practices
performance coachingOther
to enhance ability to deliver the weight management intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation Intervention | Active comparator | 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. Receives: Other: training including in-person and online; Other: organizational strategy meetings |
| Enhanced Implementation Intervention | Active comparator | 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. Receives: Other: training including in-person and online; Other: organizational strategy meetings; Other: performance coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of ACHIEVE Intervention Topics
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.
Measured: Baseline and 6 months
Self-efficacy to Deliver ACHIEVE Intervention
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.
Measured: Baseline and 6 months
Fidelity to ACHIEVE Intervention
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.
Measured: Baseline (after initial training) and 6 months
Secondary outcomes (5)
Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey
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.
Measured: Baseline and 6 months
Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey
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.
Measured: Baseline and 6 months
Consumer Sedentary Behavior
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.
Measured: Baseline and 6 months
Client Weight
Weight measured in kilograms (kg) using a calibrated scale and standardized procedures
Measured: Baseline and 6 months
Continued Site Implementation
Sites reported whether program was still being delivered six months after original study period.
Measured: 12 months (6 months after original study period of Baseline to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start16 Mar 2021
- Primary completion1 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gail Daumit, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454997
- Sponsor's protocol ID
- IRB00156866
- Acronym
- ACHIEVE-D
- Status last verified
- Aug 2025
- First submitted
- 13 Feb 2018
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow National Institute of Mental Health (NIMH) guidelines.
Publications
Jerome GJ, Goldsholl S, Dalcin AT, Gennusa Rd JV, Yuan CT, Brown K, Fink T, Minahan E, Wang NY, Daumit GL, Gudzune K. Comparing Implementation Strategies for an Evidence-Based Weight Management Program Delivered in Community Mental Health Programs: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 May 10;12:e45802. doi: 10.2196/45802.
PubMed 37163331
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting an Evidenced-based Weight Management Intervention and Testing Strategies to Increase Implementation in Community Mental Health Programs
- ClinicalTrials.gov ID
- NCT03454997
- Acronym / sponsor ID
- ACHIEVE-D / IRB00156866
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation Intervention | Active comparator | Other: training including in-person and online, Other: organizational strategy meetingsThe 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. |
| Enhanced Implementation Intervention | Active comparator | Other: training including in-person and online, Other: organizational strategy meetings, Other: performance coachingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| training including in-person and onlinetraining, motivational interviewing practice | Other | Enhanced Implementation Intervention, Standard Implementation Intervention |
| organizational strategy meetingsmeetings with leadership to optimize implementation of evidence-based practices | Other | Enhanced Implementation Intervention, Standard Implementation Intervention |
| performance coachingto enhance ability to deliver the weight management intervention | Other | Enhanced Implementation Intervention |
Primary outcome
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.
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.
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.
5 secondary outcomes
Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey
Time frame: Baseline and 6 months
Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey
Time frame: Baseline and 6 months
Consumer Sedentary Behavior
Time frame: Baseline and 6 months
Client Weight
Time frame: Baseline and 6 months
Continued Site Implementation
Time frame: 12 months (6 months after original study period of Baseline to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37163331Jerome GJ, Goldsholl S, Dalcin AT, Gennusa Rd JV, Yuan CT, Brown K, Fink T, Minahan E, Wang NY, Daumit GL, Gudzune K. Comparing Implementation Strategies for an Evidence-Based Weight Management Program Delivered in Community Mental Health Programs: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 May 10;12:e45802. doi: 10.2196/45802.
- Individual participant dataSharing planned: Yes. We will follow National Institute of Mental Health (NIMH) guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Daumit principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training including in-person and online, organizational strategy meetings and performance coaching in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of ACHIEVE Intervention Topics (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.