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YMCA-Physical Activity and Nutrition (YMCA-PAN)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Snacks and Organized Physical Activity
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring YMCA; Preventative child obesity

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Energy Balance Lab, The University of Kansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

YMCA PAN

YMCA Standard CAre

Arm Description

YMCA PAN (Physical activity and nutrition)- Consists of organized physical activity and controlled serving sizes of healthy low fat snacks

YMCA standard care - Follow the standard care of the YMCA after school Y-Care program for physical activity and nutrition

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)
Body weight and height will be measured in order to calculate BMI

Secondary Outcome Measures

Daily physical activity levels
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
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

Full Information

First Posted
March 26, 2010
Last Updated
January 8, 2014
Sponsor
University of Kansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01107678
Brief Title
YMCA-Physical Activity and Nutrition
Acronym
YMCA-PAN
Official Title
The YMCA After School Program of Physical Activity and Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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").
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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
YMCA; Preventative child obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
966 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YMCA PAN
Arm Type
Experimental
Arm Description
YMCA PAN (Physical activity and nutrition)- Consists of organized physical activity and controlled serving sizes of healthy low fat snacks
Arm Title
YMCA Standard CAre
Arm Type
Experimental
Arm Description
YMCA standard care - Follow the standard care of the YMCA after school Y-Care program for physical activity and nutrition
Intervention Type
Other
Intervention Name(s)
Healthy Snacks and Organized Physical Activity
Other Intervention Name(s)
YMCA PAN, YMCA Standard Care
Intervention Description
Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Body weight and height will be measured in order to calculate BMI
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Daily physical activity levels
Description
Length of time and intensity of the program's physical activity sessions will be measured by visual observation on a daily basis
Time Frame
Daily
Title
Daily energy intake
Description
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
Time Frame
Daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Donnelly, EdD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Energy Balance Lab, The University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States

12. IPD Sharing Statement

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