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IIR 15-364 – HSR&D Study

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IIR 15-364
DVD Lifestyle Intervention (D-ELITE)
David H. Au MD MS
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, WA
Funding Period: October 2017 - June 2021

BACKGROUND/RATIONALE:
More than a third of US Veterans who receive care through the VHA are obese, putting them at higher risk for multiple serious chronic health conditions. Developing evidence-based programs that are scalable, cost-efficient, and serve a diverse Veteran population is a priority for the VA National Center for Health Promotion and Disease Prevention (NCP). While the VA's MOVE! program is an effective lifestyle intervention for obesity, its reach has been limited. Some Veterans may best achieve weight loss with in-person group visits or by internet and mobile technology-intensive programs, while others may do better with a population-based, self-directed program that uses minimal technology. This trial is examining the effectiveness of a proven 12-month pragmatic self-directed, low technology, and low resource video-based lifestyle intervention targeting modest, clinically meaningful weight loss and increased physical activity among obese Veterans. If successful, this trial may help ease the burden that obesity places on Veterans and the health care system.

OBJECTIVE(S):
We will test whether the intervention will yield better outcomes for obese Veterans compared with usual care (UC) controls, including:
- Primary: Greater weight loss and improved physical function after 12 months.
- Secondary: Improvements in sustained weight loss, physical function and activity, diet quality and self-efficacy, sleep disturbance and impairment, and blood pressure after 24 months.

METHODS:
Using the VA Corporate Data Warehouse (CDW), we will identify Veterans in the Western US who are obese and likely free of major exclusionary conditions. We will mail an invitation to participate. For those who reply with interest, or do not respond, research staff will call the Veteran to explain the study and obtain verbal consent, as appropriate. We will assess change in weight via CDW. For co-morbidities and other outcomes, participants will complete questionnaires at baseline, and 12- and 24-months after randomization.

The lifestyle intervention is designed to achieve and maintain a weight loss of 5-10% of baseline body weight in a gradual stepwise fashion, and to gradually achieve at least 150 minutes per week of moderate-intensity physical activity, such as brisk walking. The intervention structure consists of watching one video each week for 12 weeks, focused on healthy eating, physical activity, and behavior change. Participants track their food intake and physical activity, work through a series of supplementary handouts, and have access to a lifestyle coach as desired for the first 12 months.

The study is powered on two continuous-scale endpoints, weight and SF-12. The two-sided type I error rate, =2.5%, was chosen to account for multiple comparisons using the Bonferroni adjustment. For weight, a sample of 464 total patients will be able to detect a difference in slope of 0.175kg/month between the intervention and UC groups with 90% power, two-sided alpha =2.5%, a 0.85 ICC and 2 repeated measures, while assuming 20% attrition at 12 months. For SF-12, a sample of 507 total patients will allow a standardized mean difference (Cohen's d) of 0.35 between the intervention and UC groups with power 90%, two-sided alpha =2.5%, while assuming 20% attrition at 12 months. To power our primary aim, we will enroll 500 Veterans. We will conduct a budget impact analyses to establish a business case for future implementation if the intervention is successful.

FINDINGS/RESULTS:
None as of 9/4/2018.

IMPACT:
The DELITE trial has potential to provide the evidence needed for deciding whether a low-cost, low-technology, self-directed program can be used to expand the treatment of obesity to a population-based level by improving access to obesity treatment regardless of Veteran place of residence.

PUBLICATIONS:
None at this time.


DRA: Health Systems
DRE: Prevention, Treatment - Comparative Effectiveness, TRL - Development
Keywords: Cardiovascular Disease, Gender Differences, Health Promotion and Education, Outcomes - Patient, Risk Factors, Telemedicine/Telehealth
MeSH Terms: none