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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| training including in-person and online | Other | training, motivational interviewing practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline (after initial training) and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
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Coaches -
Consumers-
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Daumit | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph Gennusa | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37163331 | Derived | 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. |
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We will follow National Institute of Mental Health (NIMH) guidelines.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices performance coaching: to enhance ability to deliver the weight management intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2025 |
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| organizational strategy meetings | Other | meetings with leadership to optimize implementation of evidence-based practices |
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| performance coaching | Other | to enhance ability to deliver the weight management intervention |
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| 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. | 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. | Baseline and 6 months |
| Client Weight | Weight measured in kilograms (kg) using a calibrated scale and standardized procedures | Baseline and 6 months |
| Continued Site Implementation | Sites reported whether program was still being delivered six months after original study period. | 12 months (6 months after original study period of Baseline to 6 months) |
| FG001 | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices |
| Staff Coach - Started |
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| Staff Coach - Finished |
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| Client With SMI - Started |
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| Client With SMI - Finished |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Implementation Intervention: Client With SMI | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices performance coaching: to enhance ability to deliver the weight management intervention |
| BG001 | Enhanced Implementation Intervention: Staff Coach | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices performance coaching: to enhance ability to deliver the weight management intervention |
| BG002 | Standard Implementation Intervention: Client With SMI | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices |
| BG003 | Standard Implementation Intervention: Staff Coach | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants from a site that withdrew without implementing the program were not included in analysis models, data was not collected. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Primary | 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. | Participants from a site that withdrew without implementing the program were not included in analysis models, data not collected. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
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| Primary | 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. | Participants from a site that withdrew without implementing the program were not included in analysis models, data not collected. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | score on a scale | Baseline (after initial training) and 6 months |
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| Secondary | 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. | Participants from a site that withdrew without implementing the program were not included in analysis models, data not collected. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | tsp/day | Baseline and 6 months |
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| Secondary | 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. | Participants from a site that withdrew without implementing the program were not included in analysis models, data not collected. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | servings/day | Baseline and 6 months |
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| Secondary | 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. | Participants from a site that withdrew without implementing the program were not included in analysis models, data not colleccted. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | hours/day | Baseline and 6 months |
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| Secondary | Client Weight | Weight measured in kilograms (kg) using a calibrated scale and standardized procedures | Participants from a site that withdrew without implementing the program were not included in analysis models, data not collected. All participants at sites that delivered the program were analyzed under modeling approach. | Posted | Mean | Standard Deviation | kg | Baseline and 6 months |
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| Secondary | Continued Site Implementation | Sites reported whether program was still being delivered six months after original study period. | A site that withdrew without implementing the program could not be included in the analysis of continued site implementation. | Posted | Number | sites | 12 months (6 months after original study period of Baseline to 6 months) | Sites | Sites |
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Baseline to 6 months
Adverse events were only collected for Client participants with serious mental illness who were participating in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices performance coaching: to enhance ability to deliver the weight management intervention | 0 | 43 | 3 | 43 | 4 | 43 |
| EG001 | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices | 0 | 29 | 3 | 29 | 1 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| mental health hospitalization | Psychiatric disorders | Systematic Assessment |
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| infection treatment | Infections and infestations | Systematic Assessment |
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| spinal injection | Surgical and medical procedures | Systematic Assessment |
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| head injury | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| outpatient procedure | Surgical and medical procedures | Systematic Assessment |
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| accident or injury | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
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| Gail Daumit MD, MHS | Johns Hopkins University School of Medicine | 410-614-6460 | gdaumit@jhmi.edu |
| Jun 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mean Difference (Net) |
| -0.6 |
| 2-Sided |
| 95 |
| -2.3 |
| 1.1 |
| Superiority |
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| OG001 | Standard Implementation Intervention- Client With SMI | 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. training including in-person and online: training, motivational interviewing practice organizational strategy meetings: meetings with leadership to optimize implementation of evidence-based practices |
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