N/A Completed N=307 Randomized Single-blind Prevention

Family-Based Nutrition Intervention for Latino Children

Obesity · Heart Failure

Source: ClinicalTrials.gov NCT00224887 ↗

Enrolled (actual)

307

Serious AEs

0.0%

Results posted

May 2021

Primary outcomePrimary: Mean Change in Body Mass Index (BMI) — 0.52; 0.66 kg/m^2

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Body Mass Index (BMI)	0.52; 0.66	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.