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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00277277
• Lead Sponsor: Bastyr University

Brief 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.

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.

Study Timeline

• Study Start: 2004-08
• Study Completion: 2005-09
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-16
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-29
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight at 8 weeks; Body Mass Index at 8 weeks; Diabetes outcomes at 8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bastyr Center for Natural Health; 🇺🇸 Seattle, Washington, United States