YMCA-Physical Activity and Nutrition (YMCA-PAN)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Donnelly, University of Kansas
ClinicalTrials.gov Identifier:
NCT01107678
First received: March 26, 2010
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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").


Condition Intervention
Childhood Obesity
Other: Healthy Snacks and Organized Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The YMCA After School Program of Physical Activity and Nutrition

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Body weight and height will be measured in order to calculate BMI


Secondary Outcome Measures:
  • Daily physical activity levels [ Time Frame: Daily ] [ Designated as safety issue: No ]
    Length of time and intensity of the program's physical activity sessions will be measured by visual observation on a daily basis

  • Daily energy intake [ Time Frame: Daily ] [ Designated as safety issue: No ]
    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


Enrollment: 966
Study Start Date: July 2007
Study Completion Date: June 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YMCA PAN
YMCA PAN (Physical activity and nutrition)- Consists of organized physical activity and controlled serving sizes of healthy low fat snacks
Other: Healthy Snacks and Organized Physical Activity
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
Other: Healthy Snacks and Organized Physical Activity
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

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").

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107678

Locations
United States, Kansas
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Joseph E Donnelly, EdD University of Kansas
  More Information

No publications provided

Responsible Party: Joseph Donnelly, Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT01107678     History of Changes
Other Study ID Numbers: HSCL16198, R01DK074909
Study First Received: March 26, 2010
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
YMCA; Preventative child obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014