Obesity Clinical Trial
Official title:
Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program: A Pilot Study in a Military Community
The objective of this study is to evaluate the effectiveness of Virtual Lifestyle Management
(VLM) as a behavior modification tool to promote weight loss, healthy eating and physical
activity patterns, in the interest of reducing risk and adverse outcomes for individuals at
high risk of type 2 diabetes (T2D) and cardiovascular disease (CVD) in a military
population.
Specific Aim: To evaluate the effect of VLM on cardiovascular risk status in participants at
high risk or individuals with T2D enrolled in the pilot study. The investigators hypothesize
that participants will show greater improvement in weight as well as glucose, blood
pressure, lipids, and self-reported diet and physical activity than will similar patients
who are not enrolled in VLM.
As the epidemic of obesity continues to grow in both the United States and military
populations, innovative lifestyle interventions that fit into the schedules of a busy
population are critical. The rising costs of obesity (direct medical costs as well as
societal costs) are staggering, and left unaddressed, they will overwhelm the budgets of
many employers. Additionally, the costs in terms of military readiness are critical. As more
career soldiers choose separation over weight reduction, the loss of institutional knowledge
and intellectual capital are consequences that will continue to be felt. A program that is
successful, scaleable, and transferable to remote locations could help stem this tide. VLM
will begin the process of allowing the internet to be used not only as an informational and
communication tool, but also as a means of accessing a comprehensive and well-validated
lifestyle program from the internet-access point of greatest convenience.
Type 2 diabetes (T2D) affects 18 million Americans(2) and costs $132 billion in expenditures
and lost productivity.(3) Treatment and prevention are essential, yet current
recommendations,(4) combining medical care with self-care, are difficult to implement.
Furthermore, strong evidence supports the use of comprehensive, intensive lifestyle
interventions for obesity among primary care patients. While such programs may help reduce
the risk of T2D onset, assist with glucose management among individuals who have T2D, and
benefit other obesity-related health problems, such programs are commonly lacking in
clinical practice.
This pilot study will test a model for the implementation of a VLM program that utilizes the
internet to address good nutrition, safe weight loss methods and the importance of physical
activity with the "virtual" support of a lifestyle coaching team to sustain participants in
their weight loss and physical activity efforts. The focus of this initiative is to promote
weight loss and healthy diet and exercise patterns, in the interest of preventing and
treating T2D, and minimizing the risk of CVD in the military community. The study will be
open to individuals who receive medical care through Wilford Hall Medical Center (WHMC)
clinics.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
| Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
| Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
| Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
| Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
| Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
| Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
| Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
| Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
| Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
| Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
| Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
| Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
| Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
| Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
| Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
| Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |