The EMBER Trial for Weight Management Engagement

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: EMBER; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System, Palo Alto, CA
  • Texas
    • Houston, Texas, United States, 77030-4211
      • Michael E. DeBakey VA Medical Center, Houston, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMBER; Self-help tool to increase weight management engagement	Behavioral: EMBER; Self-help tool to increase weight management engagement
Active Comparator: Control; List of treatments	Behavioral: Control; List of weight management programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jessica Yelena Breland, PhD MS BA, VA Palo Alto Health Care System, Palo Alto, CA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; weight loss; treatment engagement
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss
• Other Study ID Numbers: IIR 19-422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified, anonymized dataset will be created and shared with qualified investigators.
• IPD Sharing Time Frame: Datasets will be available within 1 year of publication.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No