NCT00119782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

5 years

First QC Date

July 6, 2005

Last Update Submit

August 21, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body mass index

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

Secondary Outcomes (1)

  • Self-reported dietary and physical activity behaviors

    Measured at Month 24 follow-up visit

Study Arms (2)

1

EXPERIMENTAL

Comprehensive worksite intervention

Behavioral: DietBehavioral: ExerciseBehavioral: Environment

2

EXPERIMENTAL

Delayed intervention control group

Behavioral: DietBehavioral: ExerciseBehavioral: Environment

Interventions

DietBEHAVIORAL

A dietary intervention that will promote lower calorie intake

12
ExerciseBEHAVIORAL

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

12
EnvironmentBEHAVIORAL

Increase worksite access to both healthy foods and physical activity

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 91809-1024, United States

Location

MeSH Terms

Conditions

ObesityCardiovascular DiseasesHeart Diseases

Interventions

DietExerciseEnvironment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Shirley Beresford

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations