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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01900613
Other study ID # 216443
Secondary ID
Status Completed
Phase N/A
First received July 11, 2013
Last updated July 17, 2017
Start date April 2011
Est. completion date September 2016

Study information

Verified date July 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity and overweight are health problems resulting from the interaction of predisposing genes with environmental, economic and social stimuli, in conjunction with excess caloric intake throughout growth from childhood to adulthood. Evidence suggests that a major barrier in controlling overweight/obesity is the complex interrelation of these factors, making single-approach interventions less likely to succeed than integrated, multi-faceted approaches. The proposed project aims to deliver a multi-faceted behavioral intervention developed over the past 18 months by a university-community /school-based collaborative. This project aims to provide new knowledge about the effectiveness of interventions designed specifically to achieve successful weight management among Mexican-origin children ages 3-8, and identify associated mediating factors. Deliverables will include community-based, collaborative and sustainable tools to support weight-management goals in this demographic. UC Davis and UC Cooperative Extension (UCCE) faculty form the investigator team, collaborating on key decision points with the project community in California's Central Valley. The investigators hypothesize that the identified mediating factors will increase fruit and vegetable consumption. The investigators also hypothesize an increase in the intensity and frequency of physical activity among children in the intervention group.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 8 Years
Eligibility Inclusion Criteria:

- Family with child between ages 3-8 years

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Ninos Sanos Familia Sana


Locations

Country Name City State
United States UC Davis Davis California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dobbins M, De Corby K, Robeson P, Husson H, Tirilis D. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6-18. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD007651. doi: 10.1002/14651858.CD007651. Review. Update in: Cochrane Database Syst Rev. 2013;2:CD007651. — View Citation

Haworth CM, Dale PS, Plomin R. The etiology of science performance: decreasing heritability and increasing importance of the shared environment from 9 to 12 years of age. Child Dev. 2009 May-Jun;80(3):662-73. doi: 10.1111/j.1467-8624.2009.01289.x. — View Citation

Sinha A, Kling S. A review of adolescent obesity: prevalence, etiology, and treatment. Obes Surg. 2009 Jan;19(1):113-20. doi: 10.1007/s11695-008-9650-4. Epub 2008 Aug 30. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Child BMI Over 3 years child increases in child BMI will be decreased 3 years
Secondary Parent BMI 3 years
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