EMBER Self-Help Tool for Obesity Management

No longer recruiting at 1 trial location

Overseen By Marnelle Cruz, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Age 80+, Suicide attempt, Hospitalization, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new self-help tool called EMBER to determine if it helps veterans adhere to weight loss programs offered by the Veterans Health Administration. Participants will either use EMBER or receive a list of weight management programs and will answer questions about their health and habits. The goal is to discover if EMBER encourages more veterans to participate in these programs compared to those who don't use the tool. Veterans who have used primary care at VA Palo Alto or Houston in the past year and have a BMI of 30 or higher (indicating obesity) may be suitable for this trial. As an unphased trial, this study provides veterans the chance to contribute to innovative solutions for weight management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on weight management programs rather than medication changes.

What prior data suggests that the EMBER self-help tool is safe for use in weight management?

Research has shown that EMBER is a new self-help tool designed to keep people engaged in weight management programs. Specific safety information is not yet available because the tool is still under study. However, as EMBER is a self-guided tool based on Motivational Interviewing, it is generally considered low-risk. Motivational Interviewing encourages positive behavioral changes and is typically safe. This tool aims to help individuals adhere to weight management programs, likely focusing on motivation rather than medical treatment, which suggests minimal risk of negative effects.

Since this study phase does not directly test safety, conclusive safety information is not yet available. However, the nature of the tool suggests it should be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMBER self-help tool for obesity management because it takes a fresh approach to tackling weight issues. Unlike traditional treatments that often rely on medications or structured diet and exercise programs, EMBER is a digital tool designed to boost engagement in managing weight. This innovative method empowers users to take control of their health by providing personalized support and motivation directly, potentially increasing adherence and long-term success in weight management.

What evidence suggests that the EMBER self-help tool is effective for obesity management?

Research shows that EMBER, a self-help tool tested in this trial, uses Motivational Interviewing to engage people in weight management programs. This method encourages individuals to discover their own reasons for changing behavior. It has proven effective in boosting participation in weight loss programs. Mobile health tools like EMBER have also helped people lose weight as effectively as in-person treatments. Although EMBER is relatively new, these early findings suggest it could support individuals in maintaining their weight management efforts. Participants in this trial will either use the EMBER tool or receive standard care as part of the control group. ^{1 2 3 5 6}

Who Is on the Research Team?

Jessica Yelena Breland, PhD MS BA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

The EMBER Trial is for veterans with obesity (BMI ≥ 30 kg/m2) who have used VA Palo Alto or Houston primary care in the past year. It's not for those over 80, under 18, anyone hospitalized recently, with cognitive issues, a recent suicide attempt, or who've used VA weight management programs in the last two years.

Inclusion Criteria

BMI greater than or equal to 30 kg/m2

Veteran using primary care at VA Palo Alto or Houston in prior year

Exclusion Criteria

I plan to leave VA Palo Alto or Houston in the next 6 months.

Documentation of a suicide attempt in the past 30 days

I have been hospitalized within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are enrolled and randomized to either the EMBER tool or a control group

1 week

1 visit (phone)

Initial Assessment

Participants answer questions about health beliefs and behaviors and share information from their medical record

1 week

1 visit (phone)

Treatment

Participants use the EMBER tool or receive a list of weight management programs

6 months

Ongoing engagement (phone)

Follow-up

Participants are monitored for weight management engagement, weight loss, and quality of life

6 months

2 visits (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Control
• EMBER

Trial Overview This trial tests if EMBER—a self-help tool—increases engagement in VHA weight management programs compared to a control group receiving a list of these programs. Participants are randomly assigned to either group and will provide health information at various intervals via phone.

How Is the Trial Designed?

Group I: EMBER Experimental Treatment 1 Intervention

Self-help tool to increase weight management engagement

Group II: Control Active Control 1 Intervention

List of treatments

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37884122/

The EMBER trial for weight management engagement EMBER is the first self-directed, Motivational Interviewing-based intervention designed to increase weight management program engagement.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002872

The EMBER trial for weight management engagement EMBER is the first self-directed, Motivational Interviewing-based intervention designed to increase weight management program engagement.

3. trialx.com trialx.com/clinical-trials/listings/276296/the-ember-trial-for-weight-management-engagement/

The EMBER Trial for Weight Management Engagement This study tests the effectiveness of EMBER, a self-directed tool with the goal of Enhancing Motivation for Better Engagement and Reach (EMBER) ...

4. centreforevidence.org centreforevidence.org/article/20231024-the-ember-trial-for-weight-management-engagement-a-hybrid-type-1-randomized-controlled-trial-protocol

The EMBER trial for weight management engagement Conclusion: EMBER is the first self-directed, Motivational Interviewing-based intervention designed to increase weight management program engagement. The study ...

5. researchgate.net researchgate.net/publication/374968715_The_EMBER_trial_for_weight_management_engagement_A_hybrid_type_1_randomized_controlled_trial_protocol

A hybrid type 1 randomized controlled trial protocol Background Mobile health (mHealth) interventions for weight management can result in weight loss outcomes comparable to in-person treatments.

6. withpower.com withpower.com/trial/phase-obesity-6-2022-e4e2d

EMBER Self-Help Tool for Obesity Management This trial tests whether EMBER, a motivational self-help tool, helps veterans with obesity engage in VHA weight management programs.