In-Home Weight Loss Program for Adults With Type 2 Diabetes Delivered by Interactive Cable Television Technology - Full Text View

Sponsor:	Bastyr University
Collaborator:	National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by:	Bastyr University
ClinicalTrials.gov Identifier:	NCT00277277

Purpose

The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve diabetes outcomes and reduce the need for anti-diabetic medical. This 8-week Telehealth study will compare the effects of standard weight loss advice given in a clinic setting to weight loss advice delivered in the home using an interactive cable television technology called Healthium.

Condition	Intervention
Diabetes Mellitus, Type 2	Behavioral: Healthium

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Telehealth Delivery of a Weight Loss Program in Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Weight Control

U.S. FDA Resources

Further study details as provided by Bastyr University:

Primary Outcome Measures:

Body weight at 8 weeks; Body Mass Index at 8 weeks; Diabetes outcomes at 8 weeks

Secondary Outcome Measures:

Hip/waist circumference at 8 weeks; Energy and nutrient intake at 8 weeks; Physical activity at 8 weeks

Estimated Enrollment:	19
Study Start Date:	August 2004
Estimated Study Completion Date:	September 2005

Detailed Description:

The majority of patients with Type 2 Diabetes are obese and weight loss is known to improve diabetes outcomes and reduce the need for anti-diabetic medical. The overall goal of this study is to explore the human engineering issues of a home (non-clinical) telehealth system, Healthium, utilizing an interactive television system over a broadband connection.

The study seeks to demonstrate a convenient, intuitive and inexpensive way to conduct large-scale interventions related to obesity and nutrition. This could lead to a viable public health care initiative for prevention of chronic diseases such as diabetes. The specific aims to be addressed are Aim #1: To transfer a successful internet-based weight loss program onto the Healthium interactive platform and further develop the intervention for use in patients with Type 2 diabetes. Aim #2: To conduct focus groups to determine consumer acceptability of the convenience and intuitiveness of the Healthium interface. Aim #3: To perform a pilot study in patients with Type 2 diabetes to determine whether the Healthium interface improves weight loss and diabetes outcomes relative to standard clinic-based treatment over a period of 8 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Clinical Diagnosis of TYpe 2 Diabetes, Body Mass Index 25-35; Ability to read at 8th grade level, have a working television set in the household, be willing to complete daily exercise and diet logs for the 8-233k study; be willing to attend at least 3 clinic visits; Under care of physician for diabetes -

Exclusion Criteria: Evidence of cardiac, renal, or other endocrine diseases; clinical evidence of a substance abuse or mental illness; pregnancy or anticipated pregnancy; breastfeeding; excessive alcohol consumption; anticipated major lifestyle changes

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277277

Locations

United States, Washington
Bastyr Center for Natural Health
Seattle, Washington, United States, 98028

Sponsors and Collaborators

Bastyr University

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

Principal Investigator:

Jennifer Lovejoy, PhD

Bastyr University

More Information

Additional Information:

Bastyr University Research This link exits the ClinicalTrials.gov site

Publications:

Ahring KK, Ahring JP, Joyce C, Farid NR. Telephone modem access improves diabetes control in those with insulin-requiring diabetes. Diabetes Care. 1992 Aug;15(8):971-5.

Barnard RJ, Jung T, Inkeles SB. Diet and exercise in the treatment of NIDDM. The need for early emphasis. Diabetes Care. 1994 Dec;17(12):1469-72.

Currell R, Urquhart C, Wainwright P, Lewis R. Telemedicine versus face to face patient care: effects on professional practice and health care outcomes. Nurs Times. 2001 Aug 30-Sep 5;97(35):35. No abstract available.

Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7.

Friedman RH, Kazis LE, Jette A, Smith MB, Stollerman J, Torgerson J, Carey K. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. Am J Hypertens. 1996 Apr;9(4 Pt 1):285-92.

Harvey-Berino J, Pintauro S, Buzzell P, DiGiulio M, Casey Gold B, Moldovan C, Ramirez E. Does using the Internet facilitate the maintenance of weight loss? Int J Obes Relat Metab Disord. 2002 Sep;26(9):1254-60.

Hersh WR, Wallace JA, Patterson PK, Shapiro SE, Kraemer DF, Eilers GM, Chan BK, Greenlick MR, Helfand M. Telemedicine for the Medicare population: pediatric, obstetric, and clinician-indirect home interventions. Evid Rep Technol Assess (Summ). 2001 Aug;(24 Suppl):1-32.

Meyers AW, Graves TJ, Whelan JP, Barclay DR. An evaluation of a television-delivered behavioral weight loss program: are the ratings acceptable? J Consult Clin Psychol. 1996 Feb;64(1):172-8.

Mokdad AH, Ford ES, Bowman BA, Nelson DE, Engelgau MM, Vinicor F, Marks JS. Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000 Sep;23(9):1278-83.

Starren J, Hripcsak G, Sengupta S, Abbruscato CR, Knudson PE, Weinstock RS, Shea S. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) project: technical implementation. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):25-36.

Shea S, Starren J, Weinstock RS, Knudson PE, Teresi J, Holmes D, Palmas W, Field L, Goland R, Tuck C, Hripcsak G, Capps L, Liss D. Columbia University's Informatics for Diabetes Education and Telemedicine (IDEATel) Project: rationale and design. J Am Med Inform Assoc. 2002 Jan-Feb;9(1):49-62.

Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001 Mar 7;285(9):1172-7.

Watts NB, Spanheimer RG, DiGirolamo M, Gebhart SS, Musey VC, Siddiq YK, Phillips LS. Prediction of glucose response to weight loss in patients with non-insulin-dependent diabetes mellitus. Arch Intern Med. 1990 Apr;150(4):803-6.

Wing RR, Shoemaker M, Marcus MD, McDermott M, Gooding W. Variables associated with weight loss and improvements in glycemic control in type II diabetic patients in behavioral weight control programs. Int J Obes. 1990 Jun;14(6):495-503.

Yamanouchi K, Shinozaki T, Chikada K, Nishikawa T, Ito K, Shimizu S, Ozawa N, Suzuki Y, Maeno H, Kato K, et al. Daily walking combined with diet therapy is a useful means for obese NIDDM patients not only to reduce body weight but also to improve insulin sensitivity. Diabetes Care. 1995 Jun;18(6):775-8.

ClinicalTrials.gov Identifier:	NCT00277277 History of Changes
Other Study ID Numbers:	R21 EG002311-02
Study First Received:	January 12, 2006
Last Updated:	October 29, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Bastyr University:

Telemedicine
Biobehavioral weight loss program
Body Mass Index
Blood Glucose
Diabetes Management

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012