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Completed

NCT Number: NCT00119782

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 91809-1024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

A dietary intervention that will promote lower calorie intake

Exercise

Behavioral

A physical activity intervention combining increased daily physical activity and regular, structured exercise

Environment

Behavioral

Increase worksite access to both healthy foods and physical activity

Primary outcomes

  1. Body mass index

    Time frame: Measured at Month 24 follow-up visit; adjusted for baseline body mass index

Secondary outcomes

  1. Self-reported dietary and physical activity behaviors

    Time frame: Measured at Month 24 follow-up visit

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Reducing Obesity at the Workplace: a Randomized Trial

Acronym: PACE

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2005
Registry last updated
Aug 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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