NCT00715130

Brief Summary

H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

4.9 years

First QC Date

July 11, 2008

Last Update Submit

December 6, 2011

Conditions

Keywords

EnergyObesityEnergy BalancePhysical ActivityDietary IntakeOverweightSedentaryWorksiteBody Mass IndexWeight Maintenance

Outcome Measures

Primary Outcomes (1)

  • Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.

    At study conclusion

Secondary Outcomes (1)

  • Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.

    At study conclusion

Interventions

Energy BalanceBEHAVIORAL

We propose to develop and test a comprehensive intervention that will provide simple strategies related to dietary intake and energy expenditure that individuals can follow to achieve a balance in their energy intake and expenditure, while simultaneously changing structural and environmental cues to focus on promoting information, social support and opportunities for managing energy intake and increasing physical activity.

Also known as: dietary intake, energy expenditure, energy intake, physical activity

Eligibility Criteria

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

You may qualify if:

  • Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)

You may not qualify if:

  • Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

OverweightObesitySedentary BehaviorMotor Activity

Interventions

EatingEnergy MetabolismEnergy IntakeExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaMetabolismDietMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Shirley AA Beresford, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR
  • Anne McTiernan, MD, PhD

    Fred Hutchinson Cancer Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

September 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations