N/A
N=307
Family-Based Nutrition Intervention for Latino Children
Obesity · Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00224887 ↗Enrolled (actual)
307
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Mean Change in Body Mass Index (BMI) — 0.52; 0.66 kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- In home nutrition counseling (Behavioral); standard nutrition education curriculum (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Body Mass Index (BMI) |
0.52; 0.66 | — |
Summary
Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly lower BMI one year after the intervention compared to control group children whose families receive an active placebo control.
Secondary Hypotheses In families that receive the FBC, household availability of fruits and vegetables will increase, and availability of high fat foods will decrease, as measured by multiple household food inventories, compared to control group families exposed to an active placebo intervention.
Household level of food security, mothers' food purchase motives and family food interaction will influence the effects of the FBC on household food supplies.
Eligibility Criteria
The inclusion criteria for the study are:
- Ethnicity: Mother is of Mexican descent and identifies with the Mexican-American community.
- Age: Child is between 6 and 9 years 11.9 months old.
- Family lives in the San Jose area
- Family does not plan to move out of the area within the next 12 months.
The exclusion criteria for the study are:
- Metabolic disease/syndrome associated with obesity.
- Diabetes
- Chronic gastro-intestinal disease
- Chronic renal disease
- Heart disease
- Eating disorders
- Aids/HIV infection
- Use of steroids
- Use of insulin injections
- Use of oral antidiabetic agents
- Use of thyroid hormones
- Use of growth hormones
- Other diseases or use of other medications that may impact growth based on Dr. Mendoza's assessment.
- Family shares food with 2 other families with children under the age of 12.
Data sourced from ClinicalTrials.gov (NCT00224887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.