The EMBER Trial for Weight Management Engagement

NCT05424081 | Completed Results DMC

• 1 other identifier: IIR 19-422
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Obesity

Keywords

obesity; weight loss; treatment engagement

Outcome Measures

Primary Outcomes (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.

  2-months post randomization

Secondary Outcomes (9)

• Weight Management Use

  6-months post randomization

• Number of Weight Management Visits

  6-months post-randomization

• New Weight Management Behavior

  2-months post randomization

• New Weight Management Behavior

  6-months post randomization

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

  2--months post randomization

Study Arms (2)

EMBER

EXPERIMENTAL

Self-help tool to increase weight management engagement

Behavioral: EMBER

Control

ACTIVE COMPARATOR

List of treatments

Behavioral: Control

Interventions

EMBER BEHAVIORAL

Self-help tool to increase weight management engagement

EMBER

Control BEHAVIORAL

List of weight management programs

Control

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Related Publications (1)

• 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.

  PMID: 37884122 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jessica Breland, Principal Investigator
• Organization: VA Palo Alto Health Care System

jessica.breland@va.gov

650-493-5000

Study Officials

• Jessica Yelena Breland, PhD MS BA

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant outcomes will be assessed by an outside company with no knowledge of randomization status.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: September 19, 2022
• Primary Completion: November 29, 2024
• Study Completion: March 31, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Datasets will be available within 1 year of publication.
• 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.

Locations

US (2)