YMCA-Physical Activity and Nutrition

NCT ID: NCT01107678

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 966 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-06-30

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").

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

YMCA PAN

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

Group Type: EXPERIMENTAL

Healthy Snacks and Organized Physical Activity

Intervention Type: OTHER

Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais

YMCA Standard CAre

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

Group Type: EXPERIMENTAL

Healthy Snacks and Organized Physical Activity

Intervention Type: OTHER

Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais

Interventions

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

Intervention Type: OTHER

Other Intervention Names

YMCA PAN; YMCA Standard Care

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Joseph Donnelly

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph E Donnelly, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, United States

Countries

United States

Other Identifiers

R01DK074909

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSCL16198

Identifier Type: -

Identifier Source: org_study_id