Workplace-Sponsored Diet and Exercise Program to Reduce Obesity

NCT ID: NCT00123526

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

899 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity Cardiovascular Diseases Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Worksite intervention

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

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.

Physical Activity

Intervention Type BEHAVIORAL

The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.

2

Receive no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diet

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.

Intervention Type BEHAVIORAL

Physical Activity

The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Stephenie Lemon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephenie Lemon

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL079483

Identifier Type: NIH

Identifier Source: secondary_id

View Link

223

Identifier Type: -

Identifier Source: org_study_id