NCT02291146

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
421

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

2.4 years

First QC Date

October 24, 2014

Last Update Submit

November 11, 2014

Conditions

Keywords

gardeningcookingnutrition educationHispanic Americans

Outcome Measures

Primary Outcomes (3)

  • change in adiposity

    measured by BMI, waist circumference, and body fat percentages (via Tanita scale)

    baseline and 12 weeks

  • change in blood pressure

    baseline and 12 weeks

  • change in metabolic function

    measured by fasting glucose, insulin and lipids

    baseline and 12 weeks

Secondary Outcomes (2)

  • change in dietary intake

    basline and 12 weeks

  • change in determinants of fruit and vegetable intake

    basline and 12 weeks

Other Outcomes (1)

  • change in school engagement

    basline and 12 weeks

Study Arms (2)

LA Sprouts intervention

EXPERIMENTAL

The intervention classes will be taught during a 90-minute session once a week for 12 weeks. Participants will receive a 45-minute gardening lesson, taught by a Master Gardener (supervised by Dr. Gatto). This lesson will include learning how to plant, maintain and harvest various fruits and vegetables. Supplementing the gardening lesson, a USC nutrition educator, with help from various graduate students (supervised by PI Dr. Davis), will lead a 45-minute cooking activity and nutrition education lesson. Every participant will participate in the cooking activity and sample the food. The program will include lessons on growing crops that have cultural significance to Latino youth such as nopales, beans, corn and squash (the latter three crops are commonly referred to as "the three sisters").

Behavioral: LA Sprouts intervention

control

NO INTERVENTION

Approximately 200 students in the second region who are enrolled in LA's Best will serve as control participants. After the 12-week intervention is conducted and all post-testing measures are collected on controls, a vegetable/fruit garden will be built at both control schools and the LA Sprouts program will be taught to all 3rd, 4th and 5th graders in LAs Best and their parents at the control school as a delayed intervention.

Interventions

see arm 1 description

LA Sprouts intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (1)

  • Davis JN, Martinez LC, Spruijt-Metz D, Gatto NM. LA Sprouts: A 12-Week Gardening, Nutrition, and Cooking Randomized Control Trial Improves Determinants of Dietary Behaviors. J Nutr Educ Behav. 2016 Jan;48(1):2-11.e1. doi: 10.1016/j.jneb.2015.08.009. Epub 2015 Dec 10.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Donna Spruijt-Metz, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2014

First Posted

November 14, 2014

Study Start

July 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations