NCT00123526

Brief Summary

This study will evaluate the effectiveness of an environmental worksite intervention to reduce obesity among hospital employees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
899

participants targeted

Target at P75+ for phase_3 obesity

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

3.8 years

First QC Date

July 21, 2005

Last Update Submit

September 23, 2013

Conditions

ObesityCardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    Measured at Months 12 and 24

Study Arms (2)

1

EXPERIMENTAL

Worksite intervention

Behavioral: DietBehavioral: Physical Activity

2

NO INTERVENTION

Receive no intervention

Interventions

DietBEHAVIORAL

Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.

1
Physical ActivityBEHAVIORAL

The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.

1

Eligibility Criteria

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

You may qualify if:

  • Works at least 20 hours per week at a participating hospital
  • Speaks English or Spanish

You may not qualify if:

  • Works at only one hospital within the participating hospital system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

ObesityCardiovascular DiseasesHeart Diseases

Interventions

DietExercise

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 Phenomena

Study Officials

  • Stephenie Lemon

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

September 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(1)