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

September 9, 2008
September 18, 2009
January 2008
September 2008   (final data collection date for primary outcome measure)
Bodyweight [ Time Frame: Six Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00750022 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care
Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Obesity
  • Hypertension
  • 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
  • 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
  • Experimental: E1
    Intervention: Behavioral: Usual Care
  • Active Comparator: A1
    Intervention: Behavioral: Individualized IC treatment
McDoniel SO, Wolskee P, Shen J. Treating obesity with a novel hand-held device, computer software program, and Internet technology in primary care: the SMART motivational trial. Patient Educ Couns. 2010 May;79(2):185-91. Epub 2009 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00750022
WCPC-0101
No
Scott McDoniel; Director of Clinical Affairs, Microlife Medical Home Solutions, Inc.
Colorado Center for Chronic Care Innovations, Inc.
Microlife Medical Home Solutions, Inc.
Not Provided
Colorado Center for Chronic Care Innovations, Inc.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP