HealtheTech Lifestyle Program - Full Text View

Sponsors and Collaborators:	The Cooper Institute HealtheTech
Information provided by:	The Cooper Institute
ClinicalTrials.gov Identifier:	NCT00146510

Purpose

The purpose of the study is to determine the efficacy of resting metabolic rate (RMR) using BodyGem and BalanceLog in helping overweight and obese individuals manage their weight.

Condition	Intervention	Phase
Obesity	Behavioral: HealtheLifestyle Program Behavioral: step counters with monthly feedback on logs	Phase I

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	HealtheLifestyle Behavioral Intervention Clinical Trial

Further study details as provided by The Cooper Institute:

Primary Outcome Measures:

HealtheLifestyle participants will have greater weight loss

Secondary Outcome Measures:

HealtheLifestyle Program will increase efficacy of products

Estimated Enrollment:	130
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2006

Detailed Description:

The study plans are to develop and test the efficacy of a practical, structured, and time-limited behavioral intervention (HealtheLifestyle Program) as a supplement to standard HealtheTech products. Approximately 130 participants will be recruited and randomized to either the HealtheTech Program (focusing on calorie and exercise goals using the BalanceLog for tracking), the HealtheLifestyle Program (using step counters, monthly email letters and calls providing information on activity, nutrition, and weight loss), or a delayed treatment program (after 3 months undergo the intervention above).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: healthy adult men and women, 18-60 years -

Exclusion Criteria: not currently participating in a structured diet or exercise program

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146510

Locations

United States, Texas
The Cooper Institute
Dallas, Texas, United States, 75230

Sponsors and Collaborators

The Cooper Institute

HealtheTech

Investigators

Study Director:

Heather Kitzman, MPH

The Cooper Institute

More Information

Study ID Numbers:	CI-0126
Study First Received:	September 2, 2005
Last Updated:	November 21, 2005
ClinicalTrials.gov Identifier:	NCT00146510
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cooper Institute:

weight control
compliance
physical activity

nutrition
Health Behavior
Patient Compliance

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009