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ObesityNCT05424081

The EMBER Trial for Weight Management Engagement

A study testing EMBER in people with Obesity, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
EMBER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
470 participants
Where
2 sitesUnited States
Study dates
19 Sep 2022to 31 Mar 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veteran using primary care at VA Palo Alto or Houston in prior year
  • BMI greater than or equal to 30 kg/m2

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
EMBER, Control
Keywords
obesity, weight loss, treatment engagement
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMBERBehavioural

    Self-help tool to increase weight management engagement

  • ControlBehavioural

    List of weight management programs

Study groups in NCT05424081
Study groupRoleWhat they receive
EMBERExperimentalSelf-help tool to increase weight management engagement
Receives: Behavioral: EMBER
ControlActive comparatorList of treatments
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2-months post randomization

Secondary outcomes (9)

  1. 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.

    Measured: 6-months post randomization

  2. Number of Weight Management Visits

    Number of weight management program visits per administrative data.

    Measured: 6-months post-randomization

  3. 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.

    Measured: 2-months post randomization

  4. 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.

    Measured: 6-months post randomization

  5. 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.

    Measured: 2--months post randomization

  6. 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.

    Measured: 6-months post randomization

  7. 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.

    Measured: 6-months post randomization

  8. 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.

    Measured: 2-months post randomization

  9. 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.

    Measured: 6-months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start19 Sep 2022
  3. Primary completion29 Nov 2024
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05424081
Sponsor's protocol ID
IIR 19-422
Status last verified
Jun 2026
First submitted
10 Jun 2022
Last updated
10 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified, anonymized dataset will be created and shared with qualified investigators.

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.

    PubMed 37884122

Questions about this trial

What is this clinical trial studying?

A study testing EMBER in people with Obesity, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Management Use (time frame: 2-months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05424081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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