- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385046
Project Fit:a School- and Community-based Obesity Intervention (FIT)
June 28, 2011 updated by: Michigan State University
Project Fit:a School- and Community-based Intervention to Address Physical Activity and Healthy Eating Among Low-income Elementary School Children
Project FIT is a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA.
There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones.
Study Overview
Study Type
Interventional
Enrollment (Actual)
403
Phase
- Not Applicable
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
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49501
- Grand Rapids Public Schools
-
-
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
8 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- enrolled in participating school district in grades 1-5.
Exclusion Criteria:
- None
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: physical activity and nutrition
|
physical activity and nutrition education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity measured by pedometer.
Time Frame: 2 years
|
Physical activity will be measured with a pedometer worn for 7-day period at the beginning and end of the intervention.
|
2 years
|
|
Healthy eating index quantified by the Food Frequency Questionnaire.
Time Frame: 2 years
|
The healthy eating index is a composite measure of diet quality.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Denise Holmes, PhD, Michigan State University
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.
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
August 1, 2009
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
June 22, 2011
First Submitted That Met QC Criteria
June 28, 2011
First Posted (Estimate)
June 29, 2011
Study Record Updates
Last Update Posted (Estimate)
June 29, 2011
Last Update Submitted That Met QC Criteria
June 28, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSU-123
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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