EMBER Self-Help Tool for Obesity Management

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

470 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether EMBER, a motivational self-help tool, helps veterans with obesity engage in VHA weight management programs. Veterans will either use EMBER or be informed about available programs. The study will measure if those using EMBER are more likely to join and stick with these programs.

Research Team

Jessica Yelena Breland, PhD MS BA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+