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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00288145 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Overweight Obesity |
Behavioral: WOW, Working On Wellness weight management |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Statewide Partnerships for Worksite Weight Management |
| Estimated Enrollment: | 1800 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Worksite
Exclusion Criteria:
Cohort participants:
Contacts and Locations| United States, Rhode Island | |
| Brown University | |
| Providence, Rhode Island, United States, 02912 | |
| Principal Investigator: | Kim M Gans, PhD MPH LDN | Brown University, Institute for Community Health Promotion |
| Study Director: | Judith A. Salkeld, M.S. | Brown University, Institute for Community Health Promotion |
More Information
| Responsible Party: | Kim M. Gans, Principal Investigator, Brown University, Institute for Community Health Promotion |
| ClinicalTrials.gov Identifier: | NCT00288145 History of Changes |
| Other Study ID Numbers: | R18 DK71946 |
| Study First Received: | February 6, 2006 |
| Last Updated: | March 15, 2011 |
| Health Authority: | United States: Federal Government |
|
worksite weight gain prevention (among adults) obesity (among adults) physical activity nutrition |
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |