Obesity
Conditions
Keywords
obesity, weight loss, treatment engagement
Brief summary
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.
Detailed description
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 1. Assess whether veterans randomized to EMBER are more likely to have any weight management engagement at 2-month follow-up (per electronic medical record data supplemented with self-report) compared to those randomized to the control arm (information sheet listing available programs). (Primary Outcome) 2. Assess whether veterans randomized to EMBER have greater weight management program retention, weight management behaviors (e.g., physical activity), weight loss, and quality of life gains at 6-month follow-up compared to those randomized to the control arm. (Secondary Outcomes) 3. Assess factors likely to affect EMBER's implementation. Preliminary implementation outcomes will be assessed via RE-AIM (Reach, Effectiveness, Implementation) and the Proctor et al. implementation outcomes framework (Acceptability, Appropriateness, Costs, Fidelity). (Implementation Outcomes) 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.
Interventions
BEHAVIORALEMBER
Self-help tool to increase weight management engagement
BEHAVIORALControl
List of weight management programs
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Participant outcomes will be assessed by an outside company with no knowledge of randomization status.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Veteran using primary care at VA Palo Alto or Houston in prior year * BMI greater than or equal to 30 kg/m2
Exclusion criteria
* Age 80 or older * Documentation of a suicide attempt in the past 30 days * Hospitalization in the past 30 days * Documentation or other evidence of cognitive impairment * VA weight management program use in past 2 years * Self-report from potential participant that they will not be in town for the majority of the 2 months following baseline * Self-report from potential participant they plan to leave VA Palo Alto or Houston within the next 6 months * Under age 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Management Use | 2-months post randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Management Use | 6-months post randomization | 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. |
| Number of Weight Management Visits | 6-months post-randomization | Number of weight management program visits per administrative data. |
| New Weight Management Behavior | 2-months post randomization | 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. |
| Quality of Life (Veterans RAND 12 Item Health Survey (VR-12)) | 2--months post randomization | 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. |
| Weight Loss | 6-months post randomization | 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. |
| Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat)) | 2-months post randomization | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Yelena Breland, PhD MS BA
VA Palo Alto Health Care System, Palo Alto, CA
Participant flow
Recruitment details
Potential participants were identified at the Palo and Houston VA medical centers based on administrative and clinical data. Recruitment occurred between 2022 and 2024.
Pre-assignment details
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).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.79 years STANDARD_DEVIATION 14.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 13 Participants |
| Race/Ethnicity, Customized Another race | 8 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Race/Ethnicity, Customized Black or African American | 141 Participants |
| Race/Ethnicity, Customized Declined to answer | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized White | 263 Participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 233 | 0 / 233 | 0 / 470 |
| other Total, other adverse events | 0 / 233 | 1 / 233 | 1 / 470 |
| serious Total, serious adverse events | 0 / 233 | 0 / 233 | 0 / 470 |
Outcome results
None listed