Clinical trial NCT00277277: In-Home Weight Loss Program for Adults With Type 2 Diabetes Delivered by Interactive Cable Television Technology
Official title: Telehealth Delivery of a Weight Loss Program in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Telemedicine
Biobehavioral weight loss program
Body Mass Index
Blood Glucose
Diabetes Management
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2006-01-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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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Primary outcomes:
measure: Body weight at 8 weeks; Body Mass Index at 8 weeks; Diabetes outcomes at 8 weeks
Secondary outcomes:
measure: Hip/waist circumference at 8 weeks; Energy and nutrient intake at 8 weeks; Physical activity at 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Bastyr Center for Natural Health
state: Washington
Study officials:
affiliation: Bastyr University
name: Jennifer Lovejoy, PhD
role: PRINCIPAL_INVESTIGATOR
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