HealtheTech Lifestyle Program

March 12, 2014 updated by: The Cooper Institute

HealtheLifestyle Behavioral Intervention Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

130

Phase

  • Phase 1

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

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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

-

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HealtheLifestyle participants will have greater weight loss

Secondary Outcome Measures

Outcome Measure
HealtheLifestyle Program will increase efficacy of products

Collaborators and Investigators

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

Sponsor

The Cooper Institute

Collaborators

HealtheTech

Investigators

  • Study Director: Heather Kitzman, MPH, The Cooper Institute

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

March 1, 2004

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CI-0126

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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