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

September 18, 2009 updated by: Colorado Center for Chronic Care Innovations, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Westminster, Colorado, United States, 80031
        • Colorado Center for Chronic Care Innovations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • MedGem indirect Calorimeter
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 Names:
  • MedGem indirect Calorimeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bodyweight
Time Frame: Six Months
Six Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychobehavioral: Self-Efficacy
Time Frame: Six Months
Six Months
Quality Life
Time Frame: Six Months
Six Months
Blood Pressure
Time Frame: Six Months
Six Months
Eating Behavior
Time Frame: Six Months
Six Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Center for Chronic Care Innovations, Inc.

Collaborators

Microlife Medical Home Solutions, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (ESTIMATE)

September 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCPC-0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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