Workplace-Sponsored Diet and Exercise Program to Reduce Obesity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephenie Lemon, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00123526
First received: July 21, 2005
Last updated: September 23, 2013
Last verified: September 2013

July 21, 2005
September 23, 2013
September 2004
June 2008   (final data collection date for primary outcome measure)
Body mass index [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00123526 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Workplace-Sponsored Diet and Exercise Program to Reduce Obesity
Active Living and Healthy Diet at the Workplace

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Cardiovascular Diseases
  • Heart Diseases
  • 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.
  • Behavioral: Physical Activity
    The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.
  • Experimental: 1
    Worksite intervention
    Interventions:
    • Behavioral: Diet
    • Behavioral: Physical Activity
  • No Intervention: 2
    Receive no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
899
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00123526
223, R01HL079483, R01 HL079483
Yes
Stephenie Lemon, University of Massachusetts, Worcester
University of Massachusetts, Worcester
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephenie Lemon University of Massachusetts, Worcester
University of Massachusetts, Worcester
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP