Statewide (Rhode Island and Neighboring States) Partnerships for Worksite Weight Management

April 30, 2013 updated by: Kim Gans, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Statewide Partnerships for Worksite Weight Management

The project is designed to test the effectiveness of a multilevel worksite wellness program, based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake and physical activity, compared to an attention placebo condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Accomplishment of the specific aim will be determined by a two group randomized effectiveness study (Treatment vs. Comparison) utilizing 24 RI worksites with randomization by site. The specific impact and outcome evaluation measures (BMI, DHQ-FFQ, and 7-day PAR) will be collected at Baseline, 12, and 24 months on a longitudinal cohort selected at random from the employee lists of each participating worksite. Extensive process evaluation and a mediating variable framework are also included to identify the mechanisms in successful change at both the worksite and individual level, which will maximize the potential for dissemination and generalization of the intervention as well as advance theory and improve intervention practice and policy.

Primary outcome measure will be weight (BMI).

Study Type

Interventional

Enrollment (Actual)

1700

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Worksite

  • worksite located in Rhode Island or neighboring state
  • has food service on site
  • approximately 200 - 500 employees
  • low rate of employee turnover

Exclusion Criteria:

  • worksites outside New England

Cohort participants:

  • permanent employee, who works 20 or more hours on site
  • speaks/reads some English at level to complete survey eval items
  • able to walk at a brisk pace

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: T
Treatment arm comprises one worksite in a matched site pair; one site assigned to treatment, the other site assigned to comparison. Treatment site worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management.
Behavioral: WOW, Working On Wellness weight management
Treatment site, worksite-based health promotion activities such as self-directed campaigns, lectures, small group programs, online programs, environment interventions (food service and physical)--all with focus on nutrition, physical activity and/or weight management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight (BMI)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Kim M Gans, PhD MPH LDN, Brown University, Institute for Community Health Promotion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18DK071946 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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