Workplace-Sponsored Program to Reduce Obesity | NCT00123513

Studies
Workplace-Sponsored Program to Reduce Obesity

NCT00123513

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Jun 13, 2012Estimated

Enrollment

3,938Actual

Phase

Not Applicable

Conditions

Obesity
Cardiovascular Diseases

Interventions

Diet
Exercise
Environment

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

ID	Type	Description	Link
R01HL079511	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2012

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

Sep 2004

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 21, 2005

First Submission Date that Met QC Criteria

Jul 21, 2005

First Posted Date

Jul 25, 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

Jun 12, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diana Fernandez, Associate Professor, Department of Community and Preventive Medicine, University of RochesterPrincipal Investigator

Lead Sponsor

University of RochesterOTHER

Collaborators

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to design a comprehensive nutrition and physical activity strategy to gain a broad understanding of the social and cultural role of food and physical activity among workers. Perspectives on innovative interventions that are socially feasible and culturally acceptable will also be obtained. Health lifestyle promotion interventions addressing portion control, healthy nutrition, and increasing physical activity will be tested.

Detailed Description

BACKGROUND:

Broad, population-based approaches are needed to stop or reverse the rise in obesity prevalence. According to the World Health Organization, obesity prevention can be achieved by promoting a healthy diet and a physically active lifestyle. A partnership with the Eastman Kodak Company has been developed to test a worksite intervention for obesity prevention in Rochester, New York.

DESIGN NARRATIVE:

The overall goal of this study is to design a comprehensive nutrition and physical activity strategy based on participatory research to promote a healthy lifestyle and to stop the shift of the population body mass index (BMI) curve to the right. Six pairs of worksites will be randomized to either an intervention or control group. Two cross-sectional samples of employees within each worksite will be measured at baseline and at the end of the intervention.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,938Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Worksite intervention for obesity prevention	Behavioral: Diet Behavioral: Exercise Behavioral: Environment
2	No Intervention	Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diet	Behavioral	Environmental changes in the food and physical activity environment. Cafeteria and vending machine changes, food brought from home, walking routes, and awareness building.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BMI		Measured at baseline and Year 2

Secondary Outcomes

Measure	Description	Time Frame
Number of serving of fruits and vegetables		Measured at baseline and Year 2
Number of steps a day		Measured at baseline and Year 2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full-time employees in good health

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabel D. Fernandez, MD, MPH, PhD	University of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastman Kodak Company		Rochester	New York		United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D002318	Cardiovascular Diseases

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet
D015444	Exercise
D004777	Environment

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D009043	Motor Activity

Browse Leaves

Not provided

Browse Branches

Not provided