YMCA-Physical Activity and Nutrition (YMCA-PAN)

January 8, 2014 updated by: Joseph Donnelly, University of Kansas

The YMCA After School Program of Physical Activity and Nutrition

There is an epidemic rise in the number of overweight and obese children. Overweight and obesity in children tracks into adulthood and carries elevated risk of chronic diseases such as seen with the metabolic syndrome (i.e., elevated glucose, hypertension, etc.). Low levels of PA and poor nutrition seem to be tightly linked to the increase in overweight and obesity. A minimal intervention that targets simple strategies for both sides of the energy balance equation may diminish overweight and obesity. Increasing moderate to vigorous physical activity and improving nutrition through snacks is a feasible, low cost strategy and can be disseminated nationally through the YMCA, if successful. 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 Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

966

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

    • Kansas
      • Lawrence, Kansas, United States, 66045
        • Energy Balance Lab, The University of Kansas

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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
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:
  • YMCA PAN
  • YMCA Standard Care
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:
  • YMCA PAN
  • YMCA Standard Care

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

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

Investigators

  • Principal Investigator: Joseph E Donnelly, EdD, University of Kansas

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

July 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

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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