Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119782
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2005-07-06
Brief Title:
Promoting Activity and Changes in Eating PACE to Reduce Obesity
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Reducing Obesity at the Workplace a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL079491 | NIH | None | httpsreporternihgovquickSearchR01HL079491 |