DVD Lifestyle Intervention
Status: | Active, not recruiting |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | Any |
Updated: | 3/2/2019 |
Start Date: | February 15, 2018 |
End Date: | June 30, 2021 |
DVD Lifestyle Intervention (D-ELITE)
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 had been
limited. Some Veterans may best achieve weight loss with in-person group visits or by
internet and mobile technology-intensive programs, while others with a population-based,
self-directed program that uses minimal technology. This trial examines the effectiveness of
a 12-month self-directed, low technology, and low resource lifestyle program. The program
uses a series of DVD sessions focused on healthy eating and physical activity, and encourages
participants to monitor their weight, diet, and physical activity for 24-months. For those
who want to, participants will be able to work with a lifestyle coach to help meet weight and
activity goals. The investigators hope the program will lead to 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.
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 had been
limited. Some Veterans may best achieve weight loss with in-person group visits or by
internet and mobile technology-intensive programs, while others with a population-based,
self-directed program that uses minimal technology. This trial examines the effectiveness of
a 12-month self-directed, low technology, and low resource lifestyle program. The program
uses a series of DVD sessions focused on healthy eating and physical activity, and encourages
participants to monitor their weight, diet, and physical activity for 24-months. For those
who want to, participants will be able to work with a lifestyle coach to help meet weight and
activity goals. The investigators hope the program will lead to 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.
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 including diabetes, cardiovascular
disease, hypertension, and stroke. Losing even small amounts of weight can reduce the risks
associated with those conditions. Lifestyle modification is the cornerstone of weight loss
treatment. While efficacious lifestyle interventions for obesity exist, finding
evidence-based programs that are scalable, cost-efficient, and serves a diverse VA population
is a priority for the National Center for Health Promotion and Disease Prevention (NCP). In
response, VA disseminated MOVE! Weight Management Program for Veterans (MOVE!) in 2006, a
comprehensive, evidenced-based intervention that combines diet and physical activity
counseling with behavior change strategies. MOVE! results in meaningful weight loss for those
who actively engage in the program, but less than 5% of Veterans eligible for the program
participate, and among those, few participate at a level that would result in meaningful
weight loss. To address the growing burden that obesity places on Veterans and the health
care system, VA now faces the challenge to improve access to comprehensive lifestyle
interventions using a patient-centered and population-based approach. The investigators aim
to fill this gap by producing evidence on the effectiveness of a proven 12-month pragmatic
DVD-based self-directed lifestyle intervention targeting modest, clinically meaningful weight
loss and increased physical activity among obese Veterans. The curriculum, aimed at gradual
weight loss through progressive healthful changes in diet quality and physical activity and
behavioral skills training, is grounded in the Diabetes Prevention Program's (DPP) Group
Lifestyle Balance (GLB) 12-session DVD. The program encourages supplementary goal setting and
self-monitoring via the MyFitnessPal website or paper trackers, and optional remote lifestyle
coaching. The investigators propose to leverage the VA's Corporate Data Warehouse to identify
and enroll 500 obese Veterans. The investigators are randomizing participants to receive
usual care or the lifestyle intervention. As primary outcomes, the investigators will test
whether, compared with usual care controls, intervention participants have better outcomes
through 12 months of follow-up on weight loss and self-reported physical function. Secondary
outcomes through 24 months include sustained weight loss, physical function, physical
activity, sedentary behavior, diet quality, blood pressure, sleep quality, self-efficacy, and
program reach. Dissemination work with NCP includes development of toolkits and budget impact
analyses. The investigators hypothesize that intervention participants will have more weight
loss and improved physical function, as well as improvements in physical activity, sedentary
behavior, diet quality, blood pressure, sleep quality, and self-efficacy.
higher risk for multiple serious chronic health conditions including diabetes, cardiovascular
disease, hypertension, and stroke. Losing even small amounts of weight can reduce the risks
associated with those conditions. Lifestyle modification is the cornerstone of weight loss
treatment. While efficacious lifestyle interventions for obesity exist, finding
evidence-based programs that are scalable, cost-efficient, and serves a diverse VA population
is a priority for the National Center for Health Promotion and Disease Prevention (NCP). In
response, VA disseminated MOVE! Weight Management Program for Veterans (MOVE!) in 2006, a
comprehensive, evidenced-based intervention that combines diet and physical activity
counseling with behavior change strategies. MOVE! results in meaningful weight loss for those
who actively engage in the program, but less than 5% of Veterans eligible for the program
participate, and among those, few participate at a level that would result in meaningful
weight loss. To address the growing burden that obesity places on Veterans and the health
care system, VA now faces the challenge to improve access to comprehensive lifestyle
interventions using a patient-centered and population-based approach. The investigators aim
to fill this gap by producing evidence on the effectiveness of a proven 12-month pragmatic
DVD-based self-directed lifestyle intervention targeting modest, clinically meaningful weight
loss and increased physical activity among obese Veterans. The curriculum, aimed at gradual
weight loss through progressive healthful changes in diet quality and physical activity and
behavioral skills training, is grounded in the Diabetes Prevention Program's (DPP) Group
Lifestyle Balance (GLB) 12-session DVD. The program encourages supplementary goal setting and
self-monitoring via the MyFitnessPal website or paper trackers, and optional remote lifestyle
coaching. The investigators propose to leverage the VA's Corporate Data Warehouse to identify
and enroll 500 obese Veterans. The investigators are randomizing participants to receive
usual care or the lifestyle intervention. As primary outcomes, the investigators will test
whether, compared with usual care controls, intervention participants have better outcomes
through 12 months of follow-up on weight loss and self-reported physical function. Secondary
outcomes through 24 months include sustained weight loss, physical function, physical
activity, sedentary behavior, diet quality, blood pressure, sleep quality, self-efficacy, and
program reach. Dissemination work with NCP includes development of toolkits and budget impact
analyses. The investigators hypothesize that intervention participants will have more weight
loss and improved physical function, as well as improvements in physical activity, sedentary
behavior, diet quality, blood pressure, sleep quality, and self-efficacy.
Inclusion Criteria:
- Primary care measured BMI between 30.0-44.9 kg/m2 and previous BMI in past 12 months
indicating obesity;
- Able to participate fully in all study protocol/procedures including informed consent;
- Access to DVD player or internet.
Exclusion Criteria:
- Inability to speak, read, or understand English;
- Active weight loss interventions including use of prescription weight-loss medications
in the past 3 months, current participation in group or individual weight loss
programs provided by trained personnel, had/have plans for bariatric surgery during
the study period, expected weight loss because of alternate explanations, such as from
illness;
- High variability in weight due to fluctuations in volume status (ascites - liver
disease, chronic heart failure);
- Safety and/or adherence concerns due to severe physical or mental health issues or
life expectancy <24 months;
- Pregnant, lactating, or planning to become pregnant during the study period;
- Participation in other intervention studies.
We found this trial at
1
site
Seattle, Washington 98108
Phone: 206-764-2085
Click here to add this to my saved trials