Pediatric ObesityLA SproutsNCT02291146
LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth
A study testing LA Sprouts intervention in people with Pediatric Obesity, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- LA Sprouts intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
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.
- Conditions
- Pediatric Obesity
- Being tested
- LA Sprouts intervention
- Keywords
- gardening, cooking, nutrition education, Hispanic Americans
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LA Sprouts interventionBehavioural
see arm 1 description
| Study group | Role | What they receive |
|---|---|---|
| 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"). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in adiposity
measured by BMI, waist circumference, and body fat percentages (via Tanita scale)
Measured: baseline and 12 weeks
change in blood pressure
Measured: baseline and 12 weeks
change in metabolic function
measured by fasting glucose, insulin and lipids
Measured: baseline and 12 weeks
Secondary outcomes (2)
change in dietary intake
measured via screener, specifically fruits, vegetables, fiber
Measured: basline and 12 weeks
change in determinants of fruit and vegetable intake
measured via LA Sprouts questionnaire (developed for this study), ie knowledge, preferences, self-efficacy, motivation
Measured: basline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Loma Linda University, University of Texas at Austin, University of California, Los Angeles, National Institutes of Health (NIH), Annenberg Foundation
- Responsible party
- Principal investigator, Donna Spruijt-Metz, University of Southern California
- Investigators
- Donna Spruijt-Metz, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291146
- Sponsor's protocol ID
- NIH R21 DK094066-02
- Acronym
- LA Sprouts
- Status last verified
- Nov 2014
- First submitted
- 24 Oct 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26453367
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth
- ClinicalTrials.gov ID
- NCT02291146
- Acronym / sponsor ID
- LA Sprouts / NIH R21 DK094066-02
- Conditions
- Pediatric Obesity
- Keywords
- gardening, cooking, nutrition education, Hispanic Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Loma Linda University, University of Texas at Austin, University of California, Los Angeles, National Institutes of Health (NIH), Annenberg Foundation
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA Sprouts intervention | Experimental | Behavioral: LA Sprouts interventionThe 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"). |
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LA Sprouts interventionsee arm 1 description | Behavioural | LA Sprouts intervention |
Primary outcome
change in adiposity
Time frame: baseline and 12 weeks
measured by BMI, waist circumference, and body fat percentages (via Tanita scale)
change in blood pressure
Time frame: baseline and 12 weeks
change in metabolic function
Time frame: baseline and 12 weeks
measured by fasting glucose, insulin and lipids
2 secondary outcomes
change in dietary intake
Time frame: basline and 12 weeks
change in determinants of fruit and vegetable intake
Time frame: basline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Derived from this study: PubMed 26453367Davis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Spruijt-Metz, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LA Sprouts intervention in people with Pediatric Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in adiposity (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.