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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Telehealth Delivery of a Weight Loss Program in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277277
• Other study ID #: R21 EG002311-02
• Status: Completed
• Phase: N/A
• First received: January 12, 2006
• Last updated: October 29, 2007
• Start date: August 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2007
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Weight Loss

Intervention

Behavioral:
• Healthium

Locations

Country	Name	City	State
United States	Bastyr Center for Natural Health	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Bastyr University	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight at 8 weeks; Body Mass Index at 8 weeks; Diabetes outcomes at 8 weeks
Secondary	Hip/waist circumference at 8 weeks; Energy and nutrient intake at 8 weeks; Physical activity at 8 weeks

External Links

•   Bastyr University Research