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Completed

NCT Number: NCT05424081

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States

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About this study

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

  • 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)
  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMBER

Behavioral

Self-help tool to increase weight management engagement

Control

Behavioral

List of weight management programs

Primary outcomes

  1. Weight Management Use

    Time frame: 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 outcomes

  1. Weight Management Use

    Time frame: 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.

  2. Number of Weight Management Visits

    Time frame: 6-months post-randomization

    Number of weight management program visits per administrative data.

  3. New Weight Management Behavior

    Time frame: 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.

  4. New Weight Management Behavior

    Time frame: 6-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.

  5. Quality of Life (Veterans RAND 12 Item Health Survey (VR-12))

    Time frame: 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.

  6. Quality of Life (Veterans RAND 12 Item Health Survey (VR-12))

    Time frame: 6-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.

  7. Weight Loss

    Time frame: 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.

  8. Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat))

    Time frame: 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.

  9. Physical Activity (The Stanford Leisure-Time Activity Categorical Item (L-Cat))

    Time frame: 6-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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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