Promoting Activity and Changes in Eating (PACE) to Reduce Obesity

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00119782
First received: July 6, 2005
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

Reducing the prevalence of obesity in the population is one of the Healthy People 2010 goals. Increased vigilance is required in all age groups in preventing and reversing overweight and obesity. On an individual level, behavioral factors that influence body weight include eating choices leading to excess calorie intake and physical activity patterns leading to diminished calorie expenditure. An imbalance between the two over time leads to increased weight. On a population basis, the prevalence of overweight is associated with a myriad of influences, including social, behavioral, cultural, and environmental factors as well as genetic and physiological factors. For a majority of overweight individuals, restoring a balance between energy intake and expenditure is difficult, and therefore there is an increasing emphasis on preventing obesity on a population level. The long-term goal of this research is to prevent further increase in rates of obesity in the population. In the adult population of working age, a majority of the day is spent in the worksite, suggesting that interventions at the worksite level may offer the opportunity for success in this age group. It is anticipated that this project will yield important contributions to the understanding of obesity prevention.


Condition Intervention
Obesity
Cardiovascular Diseases
Heart Diseases
Behavioral: Diet
Behavioral: Exercise
Behavioral: Environment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Obesity at the Workplace: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Body mass index [ Time Frame: Measured at Month 24 follow-up visit; adjusted for baseline body mass index ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported dietary and physical activity behaviors [ Time Frame: Measured at Month 24 follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: September 2004
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Comprehensive worksite intervention
Behavioral: Diet
A dietary intervention that will promote lower calorie intake
Behavioral: Exercise
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Behavioral: Environment
Increase worksite access to both healthy foods and physical activity
Experimental: 2
Delayed intervention control group
Behavioral: Diet
A dietary intervention that will promote lower calorie intake
Behavioral: Exercise
A physical activity intervention combining increased daily physical activity and regular, structured exercise
Behavioral: Environment
Increase worksite access to both healthy foods and physical activity

Detailed Description:

BACKGROUND:

More than half of American adults are overweight or obese, and this proportion is increasing. The health risks associated with obesity include diabetes, cardiovascular disease, arthritis, and some cancers. It is well established that on an individual level, weight gain is caused by taking in more calories than are expended. On a population basis, the prevalence of overweight and obesity is associated with a myriad of influences, including genetic and physiological factors as well as social, behavioral, cultural, and environmental factors. Behavioral factors that contribute to weight gain include eating choices that lead to increased energy intake and physical activity choices that lead to decreased energy expenditure. For a majority of overweight individuals, restoring the balance between energy intake and expenditure is difficult.

DESIGN NARRATIVE:

This study will develop and test a comprehensive intervention involving simple messages that will integrate changes in dietary intake with changes in energy expenditure, while simultaneously modifying structural and environmental factors to promote social support and opportunities for behavioral change. The study will recruit and randomize 48 worksites to a 2-year intervention in which the following will be carried out: build a physical activity intervention combining increased daily physical activity and regular, structured exercise; build a dietary intervention that will promote lower calorie intake; and increase worksite access to both healthy foods and physical activity. The primary aim is to evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites. The study will compare changes in body mass index in intervention versus control worksites using two cross-sectional surveys at baseline and follow-up. Additional assessments using biomarkers and fitness measures will be performed in a subset of employees. The research team has considerable experience with interventions at the worksite level and substantial expertise in obesity prevention.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

The study is enrolling employees only at participating worksites.

INCLUSION CRITERIA FOR WORK SITES:

  • Meets specific standard industrial codes
  • At least 20% of employees are sedentary
  • Willing to provide a list of employees
  • Able to achieve at least a 70% response rate to the baseline survey
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119782

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 91809-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Shirley Beresford Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Shirley A. A. Beresford, PhD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00119782     History of Changes
Other Study ID Numbers: 193, R01HL079491, R01 HL079491
Study First Received: July 6, 2005
Last Updated: August 21, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014