NCT01107678

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").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
966

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3.8 years

First QC Date

March 26, 2010

Last Update Submit

January 8, 2014

Conditions

Keywords

YMCA; Preventative child obesity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index (BMI)

    Body weight and height will be measured in order to calculate BMI

    3 years

Secondary Outcomes (2)

  • Daily physical activity levels

    Daily

  • Daily energy intake

    Daily

Study Arms (2)

YMCA PAN

EXPERIMENTAL

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

YMCA Standard CAre

EXPERIMENTAL

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

Interventions

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

Also known as: YMCA PAN, YMCA Standard Care
YMCA PANYMCA Standard CAre

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • kindergarten through second grade age;

You may not qualify if:

  • no BMI requirements but must meet age requirements and be available throughout the duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph E Donnelly, EdD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2010

First Posted

April 21, 2010

Study Start

July 1, 2007

Primary Completion

May 1, 2011

Study Completion

June 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations