ObesityNCT01900613
Niños Sanos, Familia Sana - A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California
A study testing Ninos Sanos Familia Sana in people with Obesity, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ninos Sanos Familia Sana
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family with child between ages 3-8 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Obesity
- Being tested
- Ninos Sanos Familia Sana
- Keywords
- child obesity, Mexican-American, Nutrition education, Intervention
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ninos Sanos Familia SanaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Niños Sanos Familia Sana consists of CBPR developed nutrition education and economic vouchers for fruit and vegetable purchase in Firebaugh supermarket Receives: Behavioral: Ninos Sanos Familia Sana |
| Comparison | Active comparator | Comparison community of San Joaquin Receives: Behavioral: Ninos Sanos Familia Sana |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI
Over 3 years child increases in child BMI will be decreased
Measured: 3 years
Secondary outcomes (1)
Parent BMI
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startApr 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adela de la Torre, PhD, Principal investigator, Center for Transnational Health, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900613
- Sponsor's protocol ID
- 216443
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19489895Sinha 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.
PubMed 18758874Dobbins 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.
PubMed 19160341Sadeghi 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.
PubMed 31096944de 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.
PubMed 24172250
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01900613
- Acronym / sponsor ID
- 216443
- Conditions
- Obesity
- Keywords
- child obesity, Mexican-American, Nutrition education, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Ninos Sanos Familia SanaNiños Sanos Familia Sana consists of CBPR developed nutrition education and economic vouchers for fruit and vegetable purchase in Firebaugh supermarket |
| Comparison | Active comparator | Behavioral: Ninos Sanos Familia SanaComparison community of San Joaquin |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Family with child between ages 3-8 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ninos Sanos Familia Sana | Behavioural | Comparison, Intervention |
Primary outcome
Child BMI
Time frame: 3 years
Over 3 years child increases in child BMI will be decreased
1 secondary outcome
Parent BMI
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 19489895Haworth 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.
- Background: PubMed 18758874Sinha 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.
- Background: PubMed 19160341Dobbins 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.
- Derived from this study: PubMed 31096944Sadeghi 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.
- Derived from this study: PubMed 24172250de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adela de la Torre, PhD principal investigator
Center for Transnational Health, UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ninos Sanos Familia Sana in people with Obesity, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child BMI (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900613, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.