NCT00194194

Brief Summary

This study is designed to gain experience with the HealtheTech measurement system (BalanceLog) in the context of a clinical trial and to develop the related treatment protocols. In this study the aim is to evaluate two interventions, one moderate and the other intensive behavioral management. The development and evaluation of a HealtheTech protocol across these two treatment settings will provide useful data about implementation (e.g., technical issues, clinical issues, participant satisfaction) and outcomes (weight loss, retention). These data can provide empirical and clinical support for practice guidelines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2004

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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 17, 2009

Status Verified

October 1, 2008

Enrollment Period

2.6 years

First QC Date

September 12, 2005

Last Update Submit

March 13, 2009

Conditions

Moderate Behavior ManagementIntensive Behavior Management

Keywords

BMIRMRPersonal Computer

Outcome Measures

Primary Outcomes (1)

  • This study is designed to gain experience with the HealtheTech measurement system (BalanceLog) in the context of a clinical trial and to develop the related treatment protocols

    12 months

Study Arms (2)

moderate

ACTIVE COMPARATOR

moderate behavioral management

Behavioral: moderate

intensive

EXPERIMENTAL

intensive behavioral management

Device: Resting Metablic Rate measurements

Interventions

moderateBEHAVIORAL

moderate behavioral management with RD

Also known as: RD
moderate
Resting Metablic Rate measurementsDEVICE

intensive behavior management

Also known as: RMR
intensive

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 25 to 43 kg/m2
  • age \> 21 years
  • access to a personal computer (PC)

You may not qualify if:

  • BMI above/below 25-43 kg/m2
  • age \< 21 years
  • no access to a personal computer (PC)
  • type 2 diabetes
  • participants taking medications known to affect weight, appetite or energy expenditure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University- Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Gary Foster, Ph.D.

    Temple University - Center for Obesity Research and Education

    PRINCIPAL INVESTIGATOR

  • Steven B Heymsfield, M.D.

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

August 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 17, 2009

Record last verified: 2008-10

Locations

US(1)