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Niños Sanos, Familia Sana - A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ninos Sanos Familia Sana
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring child obesity, Mexican-American, Nutrition education, Intervention

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Family with child between ages 3-8 years

Exclusion Criteria:

  • None

Sites / Locations

  • UC Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Comparison

Arm Description

Niños Sanos Familia Sana consists of CBPR developed nutrition education and economic vouchers for fruit and vegetable purchase in Firebaugh supermarket

Comparison community of San Joaquin

Outcomes

Primary Outcome Measures

Child BMI
Over 3 years child increases in child BMI will be decreased

Secondary Outcome Measures

Parent BMI

Full Information

First Posted
July 11, 2013
Last Updated
July 17, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01900613
Brief Title
Niños Sanos, Familia Sana - A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California
Official Title
Niños Sanos, Familia Sana (Healthy Children/Healthy Family): A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
child obesity, Mexican-American, Nutrition education, Intervention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Niños Sanos Familia Sana consists of CBPR developed nutrition education and economic vouchers for fruit and vegetable purchase in Firebaugh supermarket
Arm Title
Comparison
Arm Type
Active Comparator
Arm Description
Comparison community of San Joaquin
Intervention Type
Behavioral
Intervention Name(s)
Ninos Sanos Familia Sana
Primary Outcome Measure Information:
Title
Child BMI
Description
Over 3 years child increases in child BMI will be decreased
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Parent BMI
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Family with child between ages 3-8 years Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adela de la Torre, PhD
Organizational Affiliation
Center for Transnational Health, UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19489895
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.
Results Reference
background
PubMed Identifier
18758874
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.
Results Reference
background
PubMed Identifier
19160341
Citation
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.
Results Reference
background
PubMed Identifier
31096944
Citation
Sadeghi B, Kaiser LL, Hanbury MM, Tseregounis IE, Shaikh U, Gomez-Camacho R, Cheung RCY, Aguilera AL, Whent L, de la Torre A. A three-year multifaceted intervention to prevent obesity in children of Mexican-heritage. BMC Public Health. 2019 May 16;19(1):582. doi: 10.1186/s12889-019-6897-8.
Results Reference
derived
PubMed Identifier
24172250
Citation
de la Torre A, Sadeghi B, Green RD, Kaiser LL, Flores YG, Jackson CF, Shaikh U, Whent L, Schaefer SE. Ninos Sanos, Familia Sana: Mexican immigrant study protocol for a multifaceted CBPR intervention to combat childhood obesity in two rural California towns. BMC Public Health. 2013 Oct 31;13:1033. doi: 10.1186/1471-2458-13-1033.
Results Reference
derived

Learn more about this trial

Niños Sanos, Familia Sana - A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California

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