Expired Study
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Worcester, Massachusetts 01655


Purpose:

This study will evaluate the effectiveness of an environmental worksite intervention to reduce obesity among hospital employees.


Study summary:

BACKGROUND: Obesity is a significant public health problem in the United States, prompting policy makers and researchers to call for action against the epidemic. Obesity and associated health conditions affect all age groups and both genders, yet disproportionately affect racial and ethnic minorities. Health consequences of obesity include high blood pressure, high cholesterol, hyperinsulinemia, type 2 diabetes, heart disease, stroke, gallbladder disease, arthritis, sleep disturbances, breathing problems, and certain types of cancer. Hospitals are important worksite environments that employ large numbers of people in diverse job categories from diverse educational and socioeconomic backgrounds. DESIGN NARRATIVE: The purpose of this study is to promote weight loss among those who are overweight and obese, and prevent weight gain among those of normal weight through an environmental intervention targeted to all employees at six hospitals in central Massachusetts. The hospitals will be matched according to size, and within each matched pair randomly assigned to either the intervention or control group. The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine. Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.


Criteria:

Inclusion criteria: - Works at least 20 hours per week at a participating hospital - Speaks English or Spanish Exclusion criteria: - Works at only one hospital within the participating hospital system


Study is Available At:


Original ID:

223


NCT ID:

NCT00123526


Secondary ID:

R01HL079483


Study Acronym:


Brief Title:

Workplace-Sponsored Diet and Exercise Program to Reduce Obesity


Official Title:

Active Living and Healthy Diet at the Workplace


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Massachusetts, Worcester


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

899


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stephenie Lemon
Principal Investigator
University of Massachusetts, Worcester

Study Dates

Start Date:September 2004
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 23, 2013
First Received Date:July 21, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Body mass index
Time Frame:Measured at Months 12 and 24
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Diet
Description:Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.
Arm Name:1
Intervention Type:Behavioral
Name:Physical Activity
Description:The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Worksite intervention
Study Arm Type:No Intervention
Arm Name:2
Description:Receive no intervention

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Massachusetts, Worcester
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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