Overweight and Obesity
Conditions
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.
Interventions
OTHERtraining including in-person and online
training, motivational interviewing practice
OTHERorganizational strategy meetings
meetings with leadership to optimize implementation of evidence-based practices
OTHERperformance coaching
to enhance ability to deliver the weight management intervention
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of ACHIEVE Intervention Topics | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Client Weight | Baseline and 6 months | Weight measured in kilograms (kg) using a calibrated scale and standardized procedures |
| Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | 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. |
| Continued Site Implementation | 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. |
| Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | 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. |
| Consumer Sedentary Behavior | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 11 |
| 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 | 29 |
| 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 | 9 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Client with SMI - Left organization | 0 | 1 |
| Overall Study | Client with SMI - Lost to follow-up | 2 | 1 |
| Overall Study | Client with SMI - Withdrawal by site | 0 | 11 |
| Overall Study | Staff Coach - Left Oranization | 1 | 1 |
| Overall Study | Staff Coach - Lost to follow-up | 0 | 1 |
| Overall Study | Staff Coach - Withdrawal by Site | 0 | 2 |
| Overall Study | Staff Coach - Withdrawal by subject | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Implementation Intervention: Client With SMI | Enhanced Implementation Intervention: Client With SMI | Standard Implementation Intervention: Staff Coach | Total | Enhanced Implementation Intervention: Staff Coach |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 40 Participants | 9 Participants | 89 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 42 Participants | 9 Participants | 88 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 21 Participants | 3 Participants | 37 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 20 Participants | 5 Participants | 51 Participants | 10 Participants |
| Region of Enrollment United States | 29 Participants | 43 Participants | 9 Participants | 92 Participants | 11 Participants |
| Sex: Female, Male Female | 18 Participants | 24 Participants | 8 Participants | 60 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 1 Participants | 32 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 29 |
| other Total, other adverse events | 4 / 43 | 1 / 29 |
| serious Total, serious adverse events | 3 / 43 | 3 / 29 |
Outcome results
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.
Time frame: Baseline (after initial training) and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Fidelity to ACHIEVE Intervention | baseline | 29.5 score on a scale | Standard Deviation 2.9 |
| Enhanced Implementation Intervention- Staff Coach | Fidelity to ACHIEVE Intervention | 6 months | 29.9 score on a scale | Standard Deviation 5.9 |
| Standard Implementation Intervention- Staff Coach | Fidelity to ACHIEVE Intervention | baseline | 25.5 score on a scale | Standard Deviation 3.8 |
| Standard Implementation Intervention- Staff Coach | Fidelity to ACHIEVE Intervention | 6 months | 30.7 score on a scale | Standard Deviation 2.6 |
Comparison: comparison between baseline and 6 months across groups95% CI: [-2, 2.9]
Comparison: between groups comparison of change post training to 6 months95% CI: [-9.1, 0.8]
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.
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Knowledge of ACHIEVE Intervention Topics | baseline | 16.1 score on a scale | Standard Deviation 2.8 |
| Enhanced Implementation Intervention- Staff Coach | Knowledge of ACHIEVE Intervention Topics | 6 months | 19.9 score on a scale | Standard Deviation 1.7 |
| Standard Implementation Intervention- Staff Coach | Knowledge of ACHIEVE Intervention Topics | baseline | 13.3 score on a scale | Standard Deviation 3.5 |
| Standard Implementation Intervention- Staff Coach | Knowledge of ACHIEVE Intervention Topics | 6 months | 20.5 score on a scale | Standard Deviation 1.4 |
Comparison: comparison of baseline and 6 months across both groups95% CI: [3.9, 7.1]
Comparison: between groups differences of change between baseline and 6 months95% CI: [-2.3, 1.1]
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.
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | leading behavioral weight loss group- 6 month | 8.4 score on a scale | Standard Deviation 1.4 |
| Enhanced Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | completing weigh ins- baseline | 9.0 score on a scale | Standard Deviation 1 |
| Enhanced Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | completing weigh ins- 6 months | 8.1 score on a scale | Standard Deviation 1.6 |
| Enhanced Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | managing group session- baseline | 9.3 score on a scale | Standard Deviation 0.9 |
| Enhanced Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | managing group session- 6 months | 8.6 score on a scale | Standard Deviation 1.4 |
| Enhanced Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | leading behavioral weight loss group- baseline | 8.9 score on a scale | Standard Deviation 0.7 |
| Standard Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | managing group session- 6 months | 8.9 score on a scale | Standard Deviation 0.9 |
| Standard Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | leading behavioral weight loss group- 6 month | 8.9 score on a scale | Standard Deviation 0.7 |
| Standard Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | managing group session- baseline | 9.3 score on a scale | Standard Deviation 1.1 |
| Standard Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | completing weigh ins- baseline | 9.5 score on a scale | Standard Deviation 1 |
| Standard Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | leading behavioral weight loss group- baseline | 9.3 score on a scale | Standard Deviation 1.1 |
| Standard Implementation Intervention- Staff Coach | Self-efficacy to Deliver ACHIEVE Intervention | completing weigh ins- 6 months | 9.1 score on a scale | Standard Deviation 0.6 |
Comparison: leading behavioral weight loss group baseline to 6 months comparison95% CI: [-1.4, 0.4]
Comparison: leading behavioral weight loss group between group comparison of change95% CI: [-2, 1]
Comparison: completing weight ins baseline to 6 month comparison95% CI: [-1.4, 0.2]
Comparison: completing weigh ins between groups comparison of change95% CI: [-2.5, 0.5]
Comparison: managing a group session baseline to 6 months comparison95% CI: [-1.2, 0.3]
Comparison: managing a group session between groups comparison of change95% CI: [-2, 1.1]
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.
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | added sugar (tsp/day)- baseline | 20.7 tsp/day | Standard Deviation 15.5 |
| Enhanced Implementation Intervention- Staff Coach | Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | added sugar (tsp/day)- 6 month | 15.0 tsp/day | Standard Deviation 10.2 |
| Standard Implementation Intervention- Staff Coach | Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | added sugar (tsp/day)- baseline | 20.9 tsp/day | Standard Deviation 21 |
| Standard Implementation Intervention- Staff Coach | Added Sugar Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | added sugar (tsp/day)- 6 month | 20.0 tsp/day | Standard Deviation 21 |
Comparison: comparison of baseline to 6 months across both groups95% CI: [-6.9, 0.3]
Comparison: comparison of between group differences baseline to 6 months95% CI: [-11.4, 1.8]
Secondary
Client Weight
Weight measured in kilograms (kg) using a calibrated scale and standardized procedures
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Client Weight | baseline | 111.9 kg | Standard Deviation 27.2 |
| Enhanced Implementation Intervention- Staff Coach | Client Weight | 6 months | 106.5 kg | Standard Deviation 27.3 |
| Standard Implementation Intervention- Staff Coach | Client Weight | baseline | 114.8 kg | Standard Deviation 28.2 |
| Standard Implementation Intervention- Staff Coach | Client Weight | 6 months | 112.7 kg | Standard Deviation 30.5 |
Comparison: comparison of baseline and 6 months across groups95% CI: [-6.1, -1.6]
Comparison: between groups differences of change between baseline to 6 months95% CI: [-20.2, 6.9]
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.
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Consumer Sedentary Behavior | Baseline | 8.9 hours/day | Standard Deviation 5.9 |
| Enhanced Implementation Intervention- Staff Coach | Consumer Sedentary Behavior | 6 Month | 7.9 hours/day | Standard Deviation 6.6 |
| Standard Implementation Intervention- Staff Coach | Consumer Sedentary Behavior | Baseline | 11.0 hours/day | Standard Deviation 7.4 |
| Standard Implementation Intervention- Staff Coach | Consumer Sedentary Behavior | 6 Month | 8.5 hours/day | Standard Deviation 5.3 |
Comparison: comparison of between group differences baseline to 6 months95% CI: [-4.5, 3.3]
Comparison: comparison of baseline to 6 months across groups95% CI: [-3.1, 0.2]
Secondary
Continued Site Implementation
Sites reported whether program was still being delivered six months after original study period.
Time frame: 12 months (6 months after original study period of Baseline to 6 months)
Population: A site that withdrew without implementing the program could not be included in the analysis of continued site implementation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Continued Site Implementation | Implementing after 6 months | 4 sites |
| Enhanced Implementation Intervention- Staff Coach | Continued Site Implementation | Not implementing after 6 months | 1 sites |
| Standard Implementation Intervention- Staff Coach | Continued Site Implementation | Implementing after 6 months | 0 sites |
| Standard Implementation Intervention- Staff Coach | Continued Site Implementation | Not implementing after 6 months | 3 sites |
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.
Time frame: Baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Implementation Intervention- Staff Coach | Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | Baseline | 3.4 servings/day | Standard Deviation 1.7 |
| Enhanced Implementation Intervention- Staff Coach | Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | fruit and vegetables (servings/day)-6 months | 3.8 servings/day | Standard Deviation 2.1 |
| Standard Implementation Intervention- Staff Coach | Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | Baseline | 4.5 servings/day | Standard Deviation 4.1 |
| Standard Implementation Intervention- Staff Coach | Fruit and Vegetable Consumption as Measured by National Health Interview Survey (NHIS) Five Factor Dietary Screener Survey | fruit and vegetables (servings/day)-6 months | 4.7 servings/day | Standard Deviation 3 |
Comparison: Comparison of Baseline \& 6 Months across both groups95% CI: [-0.4, 1.1]
Comparison: Between Groups Differences of Change between Baseline \& 6 Months95% CI: [-2, 0.2]