- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00867425
Translating the Diabetes Prevention Program Into a Virtual Lifestyle Management Program
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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Lackland AFB, Texas, Forenede Stater, 78236
- Wilford Hall Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Overweight (BMI > 25 kg/m2)
- diagnosis of at least one of the following: hypertension, dyslipidemia, type 2 diabetes, glucose intolerance
- receive health care at the 59th Medical Wing of the US Air Force
- at least weekly access to a computer with high-speed internet
- at least weekly access to a scale
- able to attend an in-person orientation session
- able to understand and sign informed consent
- agree to participate in the VLM program and evaluation
Exclusion Criteria:
- known deployment within 6 months
- Primary care physician determination that moderate physical activity and/or a low-fat diet are not safe or appropriate
- pregnancy
- breastfeeding
- current weight loss therapy
- history of bariatric surgery
- plans to have bariatric surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
|
The VLM online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program (1). VLM will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. Participants will be encouraged to complete 16 online, weekly lessons. The VLM curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives. The VLM lifestyle coaching team will review these entries weekly, and provide support, feedback about progress, tips on how to problem-solve around lifestyle barriers, and guidance on how to use the "Keeping Track" functions of VLM (e.g. keeping track of weight, fat intake, calories or physical activity).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in weight
Tidsramme: 4 months
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4 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Blood Pressure
Tidsramme: 4 months
|
4 months
|
|
Lipids
Tidsramme: 4 months
|
4 months
|
|
A1C (if applicable)
Tidsramme: 4 months
|
4 months
|
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Physical Activity
Tidsramme: 4 months
|
4 months
|
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Eating Behaviors
Tidsramme: 4 months
|
4 months
|
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Health Related Quality of Life
Tidsramme: 4 months
|
4 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Kathleen M McTigue, MD, MS, MPH, University of Pittsburgh
Publikationer og nyttige links
Generelle publikationer
- Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
- Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
- ADA. All About Diabetes. found at http://www.diabetes.org/about-diabetes.jsp. 2004.
- American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2004 Jan;27 Suppl 1:S15-35. doi: 10.2337/diacare.27.2007.s15. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO08030183
- FWH20080195H
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Kliniske forsøg med Virtual Lifestyle Management
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University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Afsluttet
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Johns Hopkins UniversityItamar-Medical, Israel; Apple Inc.; Pharmaceutical Research & Manufacturers...RekrutteringAtrieflimren | OpførselForenede Stater
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Johns Hopkins UniversityAfsluttetAtrieflimren | OpførselForenede Stater
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University of CalgaryUniversity of Manitoba; The Hospital for Sick Children; University of British... og andre samarbejdspartnereRekruttering
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University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
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Rigshospitalet, DenmarkThe Novo Nordic FoundationRekruttering
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Selcuk UniversityRekruttering
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University of UtahNational Heart, Lung, and Blood Institute (NHLBI); Kaiser PermanenteAfsluttetHjerte-kar-sygdomme | Hyperkolesterolæmi | Placebo effekt | Farmaceuter | Hydroxymethylglutaryl-CoA-reduktasehæmmereForenede Stater
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University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aktiv, ikke rekrutterendeType 1-diabetes (T1D)Forenede Stater
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University of ChicagoAfsluttetHjertefejl | Højre ventrikulær dysfunktion | Højre ventrikulær svigtForenede Stater