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Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Microlife Medical Home Solutions, Inc.
Information provided by:
Colorado Center for Chronic Care Innovations, Inc.
ClinicalTrials.gov Identifier:
NCT00750022
First received: September 9, 2008
Last updated: September 18, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.


Condition Intervention
Obesity
Hypertension
 Behavioral: Individualized IC treatment
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Colorado Center for Chronic Care Innovations, Inc.:

Primary Outcome Measures:
  • Bodyweight [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychobehavioral: Self-Efficacy [ Time Frame: Six Months ] [ Designated as safety issue: No ]
  • Quality Life [ Time Frame: Six Months ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: Six Months ] [ Designated as safety issue: No ]
  • Eating Behavior [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E1 Behavioral: Usual Care
Individuals will receive standard dietary plan. Women will receive 1200 Kcal/day and men will receive 1600 Kcal/day. Individuals will receive RMR measurement at three months. RMR information will be used to help improve eating behavior.
Other Name: MedGem indirect Calorimeter
Active Comparator: A1 Behavioral: Individualized IC treatment
Individuals will receive IC measurement at baseline and three months. Nutrition and physical activity plan will be developed and adjusted from measured RMR and lifestyle.
Other Name: MedGem indirect Calorimeter

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI greater than 30 kg/m2
  • 18-70 years of age

Exclusion Criteria:

  • No participation in other weight loss efforts outside study.
  • Pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750022

Locations
United States, Colorado
Colorado Center for Chronic Care Innovations
Westminster, Colorado, United States, 80031
Sponsors and Collaborators
Colorado Center for Chronic Care Innovations, Inc.
Microlife Medical Home Solutions, Inc.
  More Information

No publications provided by Colorado Center for Chronic Care Innovations, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Scott McDoniel; Director of Clinical Affairs, Microlife Medical Home Solutions, Inc.
ClinicalTrials.gov Identifier: NCT00750022     History of Changes
Other Study ID Numbers: WCPC-0101
Study First Received: September 9, 2008
Last Updated: September 18, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013