- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291146
LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth (LA Sprouts)
November 11, 2014 updated by: Donna Spruijt-Metz, University of Southern California
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
421
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- University of Southern California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LA Sprouts intervention
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").
|
see arm 1 description
|
No Intervention: control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in adiposity
Time Frame: baseline and 12 weeks
|
measured by BMI, waist circumference, and body fat percentages (via Tanita scale)
|
baseline and 12 weeks
|
change in blood pressure
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
|
change in metabolic function
Time Frame: baseline and 12 weeks
|
measured by fasting glucose, insulin and lipids
|
baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in dietary intake
Time Frame: basline and 12 weeks
|
measured via screener, specifically fruits, vegetables, fiber
|
basline and 12 weeks
|
change in determinants of fruit and vegetable intake
Time Frame: basline and 12 weeks
|
measured via LA Sprouts questionnaire (developed for this study), ie knowledge, preferences, self-efficacy, motivation
|
basline and 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in school engagement
Time Frame: basline and 12 weeks
|
measured via LA Sprouts questionnaire (developed for this study)
|
basline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 24, 2014
First Submitted That Met QC Criteria
November 11, 2014
First Posted (Estimate)
November 14, 2014
Study Record Updates
Last Update Posted (Estimate)
November 14, 2014
Last Update Submitted That Met QC Criteria
November 11, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH R21 DK094066-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Obesity
-
Virginia Commonwealth UniversityActive, not recruitingObesity, PediatricUnited States
-
University of British ColumbiaThe Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Alberta Health services and other collaboratorsCompleted
-
Hasselt UniversityJessa HospitalCompletedObesity, Pediatric
-
Azienda Ospedaliera Universitaria Integrata VeronaNot yet recruitingObesity, Pediatric
-
University of British ColumbiaHeart and Stroke Foundation of Canada; Public Health Agency of Canada (PHAC); Childhood Obesity Foundation and other collaboratorsCompleted
-
Columbia UniversityCompletedVitamin D Deficiency | Obesity, Morbid | Obesity, Childhood | Obesity, PediatricUnited States
-
University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne UniversityCompleted
-
Medical College of WisconsinWisconsin Department of Health and Family Services; Children's Health System...TerminatedPediatric Obesity | Pediatric OverweightUnited States
-
Kahramanmaras Sutcu Imam UniversityCompletedPediatric Obesity | Pediatric DentistryTurkey
-
Central Hospital, Nancy, FranceNot yet recruiting
Clinical Trials on LA Sprouts intervention
-
Johns Hopkins UniversityNational Institute of Environmental Health Sciences (NIEHS)CompletedAsthma | Allergy | Allergic RhinitisUnited States
-
University of Southern CaliforniaNational Center for Research Resources (NCRR)CompletedObesityUnited States
-
NYU Langone HealthDepartment of Health and Human ServicesNot yet recruitingAppropriate Use of Language Across ServicesUnited States
-
Second Affiliated Hospital, School of Medicine,...Zhejiang Cancer Hospital; Beijing Shijitan Hospital, Capital Medical University and other collaboratorsCompletedNutritional Status, Immune Function, Quality of Life Uring the Progress of ChemotherapyChina
-
Oregon State UniversityUnited States Department of Agriculture (USDA)Active, not recruitingDiet, HealthyUnited States
-
Johns Hopkins UniversityMassachusetts General Hospital; National Institutes of Health (NIH); National...Terminated
-
Bispebjerg HospitalCompletedHypertension | Cardiovascular Disease | Diabetes Mellitus | HypercholesterolemiaDenmark
-
University of MichiganUniversity of MaineRecruitingUlcerative Colitis | Ulcerative Colitis Chronic MildUnited States
-
University of California, San DiegoTerminatedDiabetes | Sedentary LifestyleUnited States
-
National Institute of Allergy and Infectious Diseases...Not yet recruitingPregnancy | HIV-1-infection | PostpartumUnited States, South Africa