Family-Based Nutrition Intervention for Latino Children

NCT00224887 | Completed Results

• 2 other identifiers: 320R01HL070218
• Study Type: interventional
• Target: 307
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Mean Change in Body Mass Index (BMI)

  child's Body Mass Index

  12 months

Study Arms (2)

in home nutrition counseling

EXPERIMENTAL

In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors

Behavioral: In home nutrition counseling

standard nutrition education curriculum

ACTIVE COMPARATOR

standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid

Other: standard nutrition education curriculum

Interventions

In home nutrition counseling BEHAVIORAL

In home family-based behavioral counseling

in home nutrition counseling

standard nutrition education curriculum OTHER

video and lesson plans based on USDA Food Guide Pyramid

standard nutrition education curriculum

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Obesity; Heart Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Donna Matheson
• Organization: Stanford University

donna.matheson@stanford.edu

650-723-5895

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: September 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share