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

Obesity Clinical Trial

Official title:

Statewide Partnerships for Worksite Weight Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288145
• Other study ID #: R18DK071946
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2006
• Last updated: April 30, 2013
• Start date: June 2006
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hallam JS, Petosa R. The long-term impact of a four-session work-site intervention on selected social cognitive theory variables linked to adult exercise adherence. Health Educ Behav. 2004 Feb;31(1):88-100. — View Citation

Proper KI, Koning M, van der Beek AJ, Hildebrandt VH, Bosscher RJ, van Mechelen W. The effectiveness of worksite physical activity programs on physical activity, physical fitness, and health. Clin J Sport Med. 2003 Mar;13(2):106-17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (BMI)		24 months	No

External Links

•   department website; project description