LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth

Pediatric Obesity Clinical Trial

— LA Sprouts  

Official title:

LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291146
• Other study ID #: NIH R21 DK094066-02
• Status: Completed
• Phase: N/A
• First received: October 24, 2014
• Last updated: November 11, 2014
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overall goal of this project is to conduct a randomized controlled 12-week after school, gardening, nutrition and cooking program (called "LA Sprouts") to improve dietary intake and reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles. Approximately 400 3rd - 5th grade students participating in the LA's Best after school program will participate. Four elementary schools in Los Angeles will be selected to participate in the study. Schools will be randomized by region to either receive the intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts intervention will take place at the elementary schools, with gardens on campus specially designed and built for this project. The program will be held once a week for 12 weeks and will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and lipids), dietary intake and related behaviors, and school performance will be measured before and after the implementation of the program in both intervention and control participants. Approximately 10 additional students of the same age will be asked to participate in a focus group to evaluate the questionnaire developed for this study. In addition, approximately 20 additonal students of the same age will be asked to participate in a test-retest session to validate the reliability of the questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Normal, Overweight and Obese Children: Investigators will attempt to obtain a natural selection of normal weight children (age- & sex-specific BMI < 85th percentile based on CDC BMI growth charts (40) and overweight and obese children (BMI = 85th percentile). Based on preliminary data from these areas, investigators expect that at least 50% of the sample will be overweight or obese. There will not be an upper BMI limit.

Gender & Age: Investigators will attempt to enroll equal numbers of female and male students in 3rd through 5th grades (8-12 years of age).

Latino origin: This study will include all ethnicities, however the selected schools are >90% Latino.

Exclusion Criteria:

• The following criteria are exclusionary: presently taking medication(s) or diagnosed with any disease that could influence dietary intake or body composition; previously diagnosed with any major illness since birth (e.g. chronic birth asphyxia, cancer, etc.); any physical, cognitive, or psychological disability that would prevent participation in the study. Participants testing positive for diabetes (as determined from the fasting blood draw) will be referred for treatment. (Note: subjects with pre-diabetes will be eligible for the study). Although participant data may be excluded based on the above exclusion criteria, participation in the program classes may be allowed. Individual cases will be reviewed as they arise.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• LA Sprouts intervention
see arm 1 description

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (6)

Lead Sponsor	Collaborator
University of Southern California	Annenberg Foundation, Loma Linda University, National Institutes of Health (NIH), University of California, Los Angeles, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in school engagement	measured via LA Sprouts questionnaire (developed for this study)	basline and 12 weeks	No
Primary	change in adiposity	measured by BMI, waist circumference, and body fat percentages (via Tanita scale)	baseline and 12 weeks	No
Primary	change in blood pressure		baseline and 12 weeks	No
Primary	change in metabolic function	measured by fasting glucose, insulin and lipids	baseline and 12 weeks	No
Secondary	change in dietary intake	measured via screener, specifically fruits, vegetables, fiber	basline and 12 weeks	No
Secondary	change in determinants of fruit and vegetable intake	measured via LA Sprouts questionnaire (developed for this study), ie knowledge, preferences, self-efficacy, motivation	basline and 12 weeks	No