Clinical trial NCT05424081: The EMBER Trial for Weight Management Engagement
Official title: The EMBER Trial for Weight Management Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight loss
treatment engagement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-06-21
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight management use
timeFrame: 2-months post randomization
Secondary outcomes:
measure: Weight management use
timeFrame: 6-months post randomization
measure: Number of weight management visits
timeFrame: 6-months post-randomization
measure: New weight management behavior
timeFrame: 2- and 6-months post randomization
measure: Quality of life
timeFrame: 2- and 6-months post randomization
measure: Weight Loss
timeFrame: 6-months post randomization
measure: Physical Activity
timeFrame: 2- and 6-months post randomization
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jessica Yelena Breland, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.