NCT00146510

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Mar 2004

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

First QC Date

September 2, 2005

Last Update Submit

March 12, 2014

Conditions

Obesity

Keywords

weight controlcompliancephysical activitynutritionHealth BehaviorPatient Compliance

Outcome Measures

Primary Outcomes (1)

  • HealtheLifestyle participants will have greater weight loss

Secondary Outcomes (1)

  • HealtheLifestyle Program will increase efficacy of products

Interventions

HealtheLifestyle ProgramBEHAVIORAL
step counters with monthly feedback on logsBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cooper Institute

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

ObesityPatient ComplianceMotor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Study Officials

  • Heather Kitzman, MPH

    The Cooper Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

March 1, 2004

Study Completion

February 1, 2006

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)