The EMBER Trial for Weight Management Engagement

Obesity Clinical Trial

Official title:

The EMBER Trial for Weight Management Engagement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424081
• Other study ID #: IIR 19-422
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Jessica Y Breland, PhD MS BA
• Phone: (650) 493-5000
• Email: Jessica.Breland[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: January 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• EMBER
Self-help tool to increase weight management engagement
• Control
List of weight management programs

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6-months post randomization
Secondary	Number of weight management visits	Number of weight management program visits per administrative data.	6-months post-randomization
Secondary	New weight management behavior	Count of 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. Lowest possible value 0 new weight management behaviors, no upper limit. Any change is considered meaningful.	2- and 6-months post randomization
Secondary	Quality of life	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.	2- and 6-months post randomization
Secondary	Weight Loss	Based on difference between self-reported weight at baseline and 6-months, supplemented with medical record data when possible.	6-months post randomization
Secondary	Physical Activity	Measured with L-Cat (Kiernen et al, 2013), which is a 6-level categorical measure. An increase of one category is a clinically meaningful difference.	2- and 6-months post randomization