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

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ClinicalTrials.gov Identifier: NCT00277277
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Healthium Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Telehealth Delivery of a Weight Loss Program in Diabetes
Study Start Date : August 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Body weight at 8 weeks; Body Mass Index at 8 weeks; Diabetes outcomes at 8 weeks

Secondary Outcome Measures :
  1. Hip/waist circumference at 8 weeks; Energy and nutrient intake at 8 weeks; Physical activity at 8 weeks


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277277


Locations
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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
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Principal Investigator: Jennifer Lovejoy, PhD Bastyr University

Publications:

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ClinicalTrials.gov Identifier: NCT00277277     History of Changes
Other Study ID Numbers: R21 EG002311-02
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by Bastyr University:
Telemedicine
Biobehavioral weight loss program
Body Mass Index
Blood Glucose
Diabetes Management

Additional relevant MeSH terms:
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Diabetes Mellitus
Weight Loss
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms