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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750022
First Posted: September 10, 2008
Last Update Posted: September 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Microlife Medical Home Solutions, Inc.
Information provided by:
Colorado Center for Chronic Care Innovations, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bodyweight [ Time Frame: Six Months ]

Secondary Outcome Measures:
  • Psychobehavioral: Self-Efficacy [ Time Frame: Six Months ]
  • Quality Life [ Time Frame: Six Months ]
  • Blood Pressure [ Time Frame: Six Months ]
  • Eating Behavior [ Time Frame: Six Months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: September 21, 2009
Last Verified: September 2009