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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01015599
Other study ID # USDA no. 2005-35215-15418
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received November 17, 2009
Last updated April 29, 2010
Start date August 2005
Est. completion date May 2008

Study information

Verified date November 2009
Source Kansas State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.


Description:

The dramatic increase in the prevalence of overweight among children and adolescents has led to obesity prevention becoming a major national health priority. Although schools offer a logical choice for a setting to reach a great number of youth, these disappointing findings may be due in part to the difficulties of implementing interventions in school settings where competing demands for time have made it difficult to add anything other than academics to the school day. After-school programs may provide promise for preventing child obesity because there are fewer bureaucratic obstacles and curricular inflexibilities. A three-year group-randomized controlled trial will be conducted with random assignment at the school level . The study will use a nested cross section design with a baseline year, and two subsequent intervention years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 273
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- after-school program participant in fourth grade group

- informed parental consent

- assent to participate in Body Mass Index assessment

Exclusion Criteria:

- third or fourth grade student

- participant in study in previous year

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
HOP'N After-school Program
Daily 30 minutes of physical activity following CATCH guidelines, Daily healthful snack with fruit/vegetables, Weekly nutrition and physical activity education based on social cognitive theory.

Locations

Country Name City State
United States Kansas State University Manhattan Kansas

Sponsors (2)

Lead Sponsor Collaborator
Kansas State University Iowa State University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Coleman KJ, Geller KS, Rosenkranz RR, Dzewaltowski DA. Physical activity and healthy eating in the after-school environment. J Sch Health. 2008 Dec;78(12):633-40. doi: 10.1111/j.1746-1561.2008.00359.x. — View Citation

Geller KS, Dzewaltowski DA, Rosenkranz RR, Karteroliotis K. Measuring children's self-efficacy and proxy efficacy related to fruit and vegetable consumption. J Sch Health. 2009 Feb;79(2):51-7. doi: 10.1111/j.1746-1561.2008.00376.x. — View Citation

Geller KS, Dzewaltowski DA. Examining elementary school--aged children's self-efficacy and proxy efficacy for fruit and vegetable consumption. Health Educ Behav. 2010 Aug;37(4):465-78. doi: 10.1177/1090198109347067. Epub 2009 Oct 26. — View Citation

Geller KS, Dzewaltowski DA. Longitudinal and cross-sectional influences on youth fruit and vegetable consumption. Nutr Rev. 2009 Feb;67(2):65-76. doi: 10.1111/j.1753-4887.2008.00142.x. Review. — View Citation

Trost SG, Rosenkranz RR, Dzewaltowski D. Physical activity levels among children attending after-school programs. Med Sci Sports Exerc. 2008 Apr;40(4):622-9. doi: 10.1249/MSS.0b013e318161eaa5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index Z-Score Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008 No
Secondary physical activity Six times yearly No
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