HealtheTech Lifestyle Program | NCT00146510

Studies
HealtheTech Lifestyle Program

NCT00146510

Sponsor

The Cooper Institute

Status

Completed

Last Update Posted

Mar 13, 2014Estimated

Enrollment

130

Phase

Phase 1

Conditions

Obesity

Interventions

HealtheLifestyle Program
step counters with monthly feedback on logs

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 7, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2014

Last Update Posted Date

Mar 13, 2014Estimated

Name	Class
HealtheTech	UNKNOWN

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HealtheLifestyle participants will have greater weight loss

Secondary Outcomes

Measure	Description	Time Frame
HealtheLifestyle Program will increase efficacy of products

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather Kitzman, MPH	The Cooper Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Cooper Institute		Dallas	Texas	75230	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D010349	Patient Compliance
D009043	Motor Activity
D015438	Health Behavior

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
HealtheLifestyle Program	Behavioral
step counters with monthly feedback on logs	Behavioral