- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107678
YMCA-Physical Activity and Nutrition (YMCA-PAN)
The YMCA After School Program of Physical Activity and Nutrition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our primary outcome measurement is body mass index (BMI) as this is now recommended by major health organizations as the preferred measure for the determination of obesity. All children at YMCA After School Programs will receive either YMCA-PAN or YMCA standard care; however, we will only follow children in grades kindergarten through second grade (K-2). For children in grades K-2, we will determine if 3 years of increased physical activity and snacks lower in energy and fat and higher in nutrient density will diminish gains in BMI. We have specifically targeted an increase of moderate to vigorous physical activity (MVPA) by 225 minutes per week that is delivered in YMCA-PAN as this is a compromise between the recommendations suggested by Healthy People 2010 and the Institute of Medicine (IOM) and is administratively feasible within the existing YMCA After School Programs. YMCA-PAN would exceed the Healthy People 2010 guidelines and would provide the majority of PA for the IOM guidelines. Children would satisfy the IOM guidelines with just 15 additional minutes of MVPA accrued throughout the day in physical education class or free play. Finally, YMCA PAN would provide opportunity for PA at the very time the guidelines call "most critical:" the hours between 3 and 6pm when children have finished the school day and frequently are sedentary. For the nutritional component, we are targeting snacks, as snacks are part of the YMCA after school programs, snacks contribute significantly to 24 hour energy intake, children are increasingly in control of the snacks they consume, and we have previously diminished 24 hour energy intake and fat intake using snacks in elementary school children.
We will provide this intervention using regular YMCA staff and use the regular time periods for PA that exist in the YMCA after school programs. We will also use the regular YMCA staff to provide snacks. Specifically, we expect that children receiving YMCA-PAN will show smaller changes in BMI after 3 years of the intervention when compared to children not receiving YMCA-PAN (i.e. standard, existing YMCA after school program or "YMCA standard care").
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kansas
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Lawrence, Kansas, United States, 66045
- Energy Balance Lab, The University of Kansas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- kindergarten through second grade age;
Exclusion Criteria:
- no BMI requirements but must meet age requirements and be available throughout the duration of the study
Study Plan
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 |
---|---|
Experimental: YMCA PAN
YMCA PAN (Physical activity and nutrition)- Consists of organized physical activity and controlled serving sizes of healthy low fat snacks
|
Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais
Other Names:
|
Experimental: YMCA Standard CAre
YMCA standard care - Follow the standard care of the YMCA after school Y-Care program for physical activity and nutrition
|
Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (BMI)
Time Frame: 3 years
|
Body weight and height will be measured in order to calculate BMI
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily physical activity levels
Time Frame: Daily
|
Length of time and intensity of the program's physical activity sessions will be measured by visual observation on a daily basis
|
Daily
|
Daily energy intake
Time Frame: Daily
|
Energy intake of the snacks served during the program will be measured by visual observation in both the intervention and control schools on a daily basis
|
Daily
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph E Donnelly, EdD, University of Kansas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSCL16198
- R01DK074909 (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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