NCT01900613

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

5.4 years

First QC Date

July 11, 2013

Last Update Submit

July 17, 2017

Conditions

Obesity

Keywords

child obesityMexican-AmericanNutrition educationIntervention

Outcome Measures

Primary Outcomes (1)

  • Child BMI

    Over 3 years child increases in child BMI will be decreased

    3 years

Secondary Outcomes (1)

  • Parent BMI

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Ninos Sanos Familia Sana

Comparison

ACTIVE COMPARATOR

Comparison community of San Joaquin

Behavioral: Ninos Sanos Familia Sana

Interventions

Ninos Sanos Familia SanaBEHAVIORAL
ComparisonIntervention

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Family with child between ages 3-8 years

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Davis, California, 95616, United States

Location

Related Publications (5)

  • 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.

    PMID: 19489895BACKGROUND

  • 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.

    PMID: 18758874BACKGROUND

  • 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.

    PMID: 19160341BACKGROUND

  • 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.

    PMID: 31096944DERIVED

  • 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.

    PMID: 24172250DERIVED

MeSH Terms

Conditions

ObesityPediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Adela de la Torre, PhD

    Center for Transnational Health, UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 16, 2013

Study Start

April 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

US(1)