Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care - Full Text View

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

MedlinePlus related topics:

High Blood Pressure Obesity Weight Control

ChemIDplus related topics:

BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study

Official Title:	Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.

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
E1: Experimental	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.
A1: Active Comparator	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.

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

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

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Weight Loss

Vascular Diseases

Nutrition Disorders

Overweight

Overnutrition

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Colorado Center for Chronic Care Innovations, Inc. Microlife Medical Home Solutions, Inc.
Information provided by:	Colorado Center for Chronic Care Innovations, Inc.
ClinicalTrials.gov Identifier:	NCT00750022