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Sponsors and Collaborators: |
Colorado Center for Chronic Care Innovations, Inc. Microlife |
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Information provided by: | Colorado Center for Chronic Care Innovations, Inc. |
ClinicalTrials.gov Identifier: | NCT00624598 |
The purpose of this study is to evaluate the short-term effect of a technology based weight reduction program for obese (BMI > 30 kg/m2) adults in a primary care office.
Condition | Intervention |
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Obesity Hypertension |
Behavioral: SMART |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Phase I Study of Integrating RMR Technology and Email Counseling in a PCP Office. |
Enrollment: | 110 |
Study Start Date: | January 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SMART Group: Experimental
The experimental group will have a nutrition program based solely on measured resting metabolic rate. The nutrition plan will be a specific calorie level that will promote a 1-2.5 lb per week weight reduction. No experimental participants' nutrition plan will be below 1200 Kcal/day for women or 1600 Kcal/day for men. Second, the experimental group will receive a downloadable copy of a computerized nutrition software program (BalanceLog: Microlife USA, Inc. Golden, CO) that functions s on a Windows 2000-XP or Palm operating system.
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Behavioral: SMART
Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.
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Usual Care: Active Comparator
Standard 1200 kcal/day diet (women) 1600 kcal/day diet (men) using a sample 3-day menu program. The diet will be follow current government based recommendations for carbohydrates (i.e. 55%), fat (30%), and protein (15%). Study participants will receive a standard paper-based food and exercise journal
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Behavioral: SMART
Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
Westminster Medical Center | |
Westminster, Colorado, United States, 80031 | |
Westmed Family Healthcare | |
Westminster, Colorado, United States, 80031 |
Responsible Party: | Capella University ( Scott McDoniel ) |
Study ID Numbers: | C41 # 001 |
Study First Received: | February 19, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00624598 |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity Vascular Diseases |
Nutrition Disorders Overweight Overnutrition Hypertension |
Cardiovascular Diseases |