Workplace-Sponsored Diet and Exercise Program to Reduce Obesity

Obesity Clinical Trial

Official title:

Active Living and Healthy Diet at the Workplace

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123526
• Other study ID #: 223
• Secondary ID: R01HL079483
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2005
• Last updated: September 23, 2013
• Start date: September 2004
• Est. completion date: June 2008

Study information

• Verified date: September 2013
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 899
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index		Measured at Months 12 and 24	No