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This study will test whether EMBER, a self-help tool to increase weight loss treatment engagement, helps veterans engage in Veterans Health Administration (VHA) weight management programs. Participants will be randomly assigned to receive EMBER or a list of weight management programs (the control group). They will answer questions about health beliefs and behaviors and share information from their medical record at the start of the study, 2-months after the start of the study, and 6-months after the start of the study. Participants will receive compensation for each of these contacts. Participants will also receive a reminder call 10 days after they enroll in the study. All study contacts will be over the phone. The main hypothesis is that people who receive EMBER will be more likely to use VHA weight management programs than people in the control group.
Background Almost 40% of veterans using the Veterans Health Administration (VHA) have obesity. However, few patients use VHA's effective weight management programs. This study tests the effectiveness of EMBER, a self-directed tool with the goal of Enhancing Motivation for Better Engagement and Reach (EMBER) for weight management. It is available in paper and digital formats. EMBER is not a weight management program, instead it engages veterans in existing programs by informing and guiding choices about weight management.
Specific Aims
Methodology Randomized two site Hybrid Type 1 Effectiveness-Implementation Trial among veteran primary care patients with obesity in VA. Participants (N=470) will be randomized to EMBER or a control condition consisting of a list of available weight management programs. Logistic regressions will be used to assess Aims 1 and 2. Aim 3 results are descriptive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMBER | Experimental | Self-help tool to increase weight management engagement |
|
| Control | Active Comparator | List of treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMBER | Behavioral | Self-help tool to increase weight management engagement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Management Use | Dichotomous variable representing whether participant has 1+ VA weight management visits in the 2 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question. | 2-months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Management Use | Dichotomous variable representing whether participant has 1+ VA weight management visits in the 6 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question. | 6-months post randomization |
| Number of Weight Management Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Yelena Breland, PhD MS BA | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States | ||
| Michael E. DeBakey VA Medical Center, Houston, TX |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37884122 | Background | Breland JY, Fletcher TL, Maguen S, Timko C, Raikov I, Boothroyd DB, Frayne SM. The EMBER trial for weight management engagement: A hybrid type 1 randomized controlled trial protocol. Contemp Clin Trials. 2023 Dec;135:107364. doi: 10.1016/j.cct.2023.107364. Epub 2023 Oct 24. |
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A de-identified, anonymized dataset will be created and shared with qualified investigators.
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Datasets will be available within 1 year of publication.
Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by VA Office of Research & Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.
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Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1).
Potential participants were identified at the Palo and Houston VA medical centers based on administrative and clinical data. Recruitment occurred between 2022 and 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | EMBER | Self-help tool to increase weight management engagement |
| FG001 | Control | List of treatments |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1).
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| ID | Title | Description |
|---|---|---|
| BG000 | EMBER | Self-help tool to increase weight management engagement |
| BG001 | Control | List of treatments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). |
| 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 | Weight Management Use | Dichotomous variable representing whether participant has 1+ VA weight management visits in the 2 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). | Posted | Count of Participants | Participants | 2-months post randomization |
|
From enrollment through 6-month follow-up
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMBER | Self-help tool to increase weight management engagement | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation with plan and/or intent | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Breland, Principal Investigator | VA Palo Alto Health Care System | 650-493-5000 | jessica.breland@va.gov |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2021 | Mar 9, 2026 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2023 | Sep 11, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participant outcomes will be assessed by an outside company with no knowledge of randomization status.
| Control |
| Behavioral |
List of weight management programs |
|
Number of weight management program visits per administrative data. |
| 6-months post-randomization |
| New Weight Management Behavior | Count patients with new weight management behaviors since baseline visit via self-report to question based on NHANES item assessing whether participant tried to lose weight and how. Any change is considered meaningful. | 2-months post randomization |
| New Weight Management Behavior | Count patients with new weight management behaviors since baseline visit via self-report to question based on NHANES item assessing whether participant tried to lose weight and how. Any change is considered meaningful. | 6-months post randomization |
| Quality of Life (Veterans RAND 12 Item Health Survey (VR-12)) | Self-report of quality of life as assessed with the VR12 physical and mental health composite scores (Boston University School of Public Health). Scores are standardized T-scores with mean = 50 and a standard deviation of 10. For individuals on the physical health score, a 6.5 unit change is considering clinically meaningful. For individuals on the mental health score, a 7.9 unit change is considering clinically meaningful. At the population level, a 1 unit change is considered clinically meaningful. Higher scores represent better quality of life. | 2--months post randomization |
| Quality of Life (Veterans RAND 12 Item Health Survey (VR-12)) | Self-report of quality of life as assessed with the VR12 physical and mental health composite scores (Boston University School of Public Health). Scores are standardized T-scores with mean = 50 and a standard deviation of 10. For individuals on the physical health score, a 6.5 unit change is considering clinically meaningful. For individuals on the mental health score, a 7.9 unit change is considering clinically meaningful. At the population level, a 1 unit change is considered clinically meaningful. Higher scores represent better quality of life. | 6-months post randomization |
| Weight Loss | Number of participants with at least 5% weight loss at 6-months based on difference between self-reported weight at baseline and 6-months, supplemented with medical record data when possible. | 6-months post randomization |
| Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat)) | Measured with Stanford Leisure-Time Activity Categorical Item (L-Cat), which is a 6-level categorical measure with lower scores indicating less physical activity, which we scored from 1-6. An increase of one category is a clinically meaningful difference. | 2-months post randomization |
| Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat)) | Measured with Stanford Leisure-Time Activity Categorical Item (L-Cat), which is a 6-level categorical measure with lower scores indicating less physical activity, which we scored from 1-6. An increase of one category is a clinically meaningful difference. | 6-months post randomization |
| Houston |
| Texas |
| 77030-4211 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants completed baseline assessments, but withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). | Count of Participants | Participants |
|
List of treatments |
|
|
| Secondary | Weight Management Use | Dichotomous variable representing whether participant has 1+ VA weight management visits in the 6 months after baseline, per administrative data and/or self-report of use of VA weight management programs via single item question. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). | Posted | Count of Participants | Participants | 6-months post randomization |
|
|
|
| Secondary | Number of Weight Management Visits | Number of weight management program visits per administrative data. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). | Posted | Median | Inter-Quartile Range | Weight management visits | 6-months post-randomization |
|
|
|
| Secondary | New Weight Management Behavior | Count patients with new weight management behaviors since baseline visit via self-report to question based on NHANES item assessing whether participant tried to lose weight and how. Any change is considered meaningful. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up. | Posted | Count of Participants | Participants | 2-months post randomization |
|
|
|
| Secondary | New Weight Management Behavior | Count patients with new weight management behaviors since baseline visit via self-report to question based on NHANES item assessing whether participant tried to lose weight and how. Any change is considered meaningful. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up for self-report. | Posted | Count of Participants | Participants | 6-months post randomization |
|
|
|
| Secondary | Quality of Life (Veterans RAND 12 Item Health Survey (VR-12)) | Self-report of quality of life as assessed with the VR12 physical and mental health composite scores (Boston University School of Public Health). Scores are standardized T-scores with mean = 50 and a standard deviation of 10. For individuals on the physical health score, a 6.5 unit change is considering clinically meaningful. For individuals on the mental health score, a 7.9 unit change is considering clinically meaningful. At the population level, a 1 unit change is considered clinically meaningful. Higher scores represent better quality of life. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up. | Posted | Mean | Standard Deviation | Standardized T-scores | 2--months post randomization |
|
|
|
| Secondary | Quality of Life (Veterans RAND 12 Item Health Survey (VR-12)) | Self-report of quality of life as assessed with the VR12 physical and mental health composite scores (Boston University School of Public Health). Scores are standardized T-scores with mean = 50 and a standard deviation of 10. For individuals on the physical health score, a 6.5 unit change is considering clinically meaningful. For individuals on the mental health score, a 7.9 unit change is considering clinically meaningful. At the population level, a 1 unit change is considered clinically meaningful. Higher scores represent better quality of life. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up. | Posted | Mean | Standard Deviation | Standardized T-scores | 6-months post randomization |
|
|
|
| Secondary | Weight Loss | Number of participants with at least 5% weight loss at 6-months based on difference between self-reported weight at baseline and 6-months, supplemented with medical record data when possible. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up and/or did not have administrative weight data. | Posted | Count of Participants | Participants | 6-months post randomization |
|
|
|
| Secondary | Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat)) | Measured with Stanford Leisure-Time Activity Categorical Item (L-Cat), which is a 6-level categorical measure with lower scores indicating less physical activity, which we scored from 1-6. An increase of one category is a clinically meaningful difference. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up. | Posted | Median | Inter-Quartile Range | Score on a scale | 2-months post randomization |
|
|
|
| Secondary | Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat)) | Measured with Stanford Leisure-Time Activity Categorical Item (L-Cat), which is a 6-level categorical measure with lower scores indicating less physical activity, which we scored from 1-6. An increase of one category is a clinically meaningful difference. | Four participants were enrolled, but were not randomized because they did not complete the baseline assessment (n=3) or because they were found to be ineligible after enrollment (n=1). Five participants withdrew permission to use self-report and/or administrative data (EMBER n=3, Control n = 2). The remaining participants were lost to follow-up. | Posted | Median | Inter-Quartile Range | Score on a scale | 6-months post randomization |
|
|
|
| 233 |
| 0 |
| 233 |
| 0 |
| 233 |
| EG001 | Control | List of treatments | 0 | 233 | 0 | 233 | 1 | 233 |
| EG002 | Prior to Randomization | Event occurred after enrollment, but prior to randomization | 0 | 470 | 0 | 470 | 1 | 470 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |