A School-based Gardening Obesity Intervention for Low-income Minority Children
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ClinicalTrials.gov Identifier: NCT02668744 |
Recruitment Status :
Completed
First Posted : January 29, 2016
Last Update Posted : October 7, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Behavioral: Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3302 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Texas Sprouts: A School-based Gardening Obesity Intervention for Low-income Minority Children |
Actual Study Start Date : | September 1, 2016 |
Actual Primary Completion Date : | May 30, 2019 |
Actual Study Completion Date : | April 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention
TX Sprouts
|
Behavioral: Intervention
The intervention consists of building edible gardens at each the eight participating and eligible schools. Educators will be provided to lead 18 gardening, nutrition and cooking lessons throughout the school year intervention to all 3-5th grade students. Nine gardening, nutrition, and cooking classes will be taught to parents every month. Garden Leadership Coalitions (GLCs), made up of parents, teachers and school staff, will be formed and training/resources provided to help with adoption of the program. Training and resources will be provided to the GLCs and teachers in the 2nd year to assist with sustainability. |
Placebo Comparator: Control
Delayed Intervention
|
Behavioral: Intervention
The intervention consists of building edible gardens at each the eight participating and eligible schools. Educators will be provided to lead 18 gardening, nutrition and cooking lessons throughout the school year intervention to all 3-5th grade students. Nine gardening, nutrition, and cooking classes will be taught to parents every month. Garden Leadership Coalitions (GLCs), made up of parents, teachers and school staff, will be formed and training/resources provided to help with adoption of the program. Training and resources will be provided to the GLCs and teachers in the 2nd year to assist with sustainability. |
- To test the effect of the Sprouts intervention on the changes in dietary intake (fruit and vegetables servings) in the children. [ Time Frame: One year ]Evaluation measures will be collected one time at baseline and end of the school year in both arms (intervention and control schools). A child questionnaire will be administered and include questions about dietary intake of fruits and vegetables to assess their eating habits.
- To test the effect of the Sprouts intervention on the changes in BMI in the children. [ Time Frame: One year ]
Evaluation measures will be collected one time at baseline and end of the school year in both arms (intervention and control schools). Measurements will occur during the first four weeks of school in the fall and the last four weeks of school in the spring.
Weight will be measured using a SECA (model 869) digital scale to the nearest 0.1 kg, and height will be measured using a wall-mounted stadiometer to the nearest 0.1 cm. BMI (kg/m2) and BMI percentiles for CDC age- and gender-specific values will be determined using EpiInfo 2005.
- To test the effect of the Sprouts intervention on the changes in dietary intake (fruit and vegetables servings) in the parents. [ Time Frame: One year ]Evaluation measures will be collected one time at baseline and end of the school year in both arms (intervention and control schools). A parent questionnaire will be administered and include questions about dietary intake of fruits and vegetables to assess their eating habits.
- To test the effect of the Sprouts intervention on changes in BMI in the parents. [ Time Frame: 4 years ]
Evaluation measures will be collected one time at baseline and end of the school year in both arms (intervention and control schools). Measurements will occur during the first four weeks of school in the fall and the last four weeks of school in the spring.
Weight will be measured using a SECA (model 869) digital scale to the nearest 0.1 kg, and height will be measured using a wall-mounted stadiometer to the nearest 0.1 cm. BMI (kg/m2) and BMI percentiles for CDC age- and gender-specific values will be determined using EpiInfo 2005.
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Ages Eligible for Study: | 8 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Weight status: Normal weight children (age- and sex-specific BMI<85th percentile based on CDC BMI growth charts68) and overweight and obese children (BMI≥85th percentile).
- Gender and Age: Students in 3rd-5th grades (8 to 11 y) and their parents
- Hispanic Origin: This study will include all ethnicities/races; however, the selected schools are >50% Hispanic, and therefore, we expect the majority of our students and parents to be Hispanic.
Exclusion Criteria:
- Children or parents 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668744
United States, Texas | |
Barbara Jordan Elementary | |
Austin, Texas, United States, 78724 | |
Decker Elementary | |
Austin, Texas, United States, 78724 | |
Oak Meadows Elementary | |
Austin, Texas, United States, 78724 | |
Pleasant Hill Elementary | |
Austin, Texas, United States, 78745 | |
Casey Elementary | |
Austin, Texas, United States, 78748 | |
Hart Elementary | |
Austin, Texas, United States, 78753 | |
McBee Elementary | |
Austin, Texas, United States, 78758 | |
Booker T. Washington | |
Elgin, Texas, United States, 78621 | |
Elgin Elementary | |
Elgin, Texas, United States, 78621 | |
Neidig Elementary | |
Elgin, Texas, United States, 78621 | |
Carver Elementary | |
Georgetown, Texas, United States, 78626 | |
Mitchell Elementary | |
Georgetown, Texas, United States, 78626 | |
Pickett Elementary | |
Georgetown, Texas, United States, 78626 | |
Purl Elementary | |
Georgetown, Texas, United States, 78626 | |
Callison Elementary | |
Round Rock, Texas, United States, 78664 | |
Voigt Elementary | |
Round Rock, Texas, United States, 78664 |
Principal Investigator: | Jaimie N Davis, PhD | University of Texas at Austin |
Responsible Party: | Jaimie N. Davis, Associate Professor, University of Texas at Austin |
ClinicalTrials.gov Identifier: | NCT02668744 |
Other Study ID Numbers: |
1R01HL123865-01A1 ( U.S. NIH Grant/Contract ) R01HL123865 ( U.S. NIH Grant/Contract ) |
First Posted: | January 29, 2016 Key Record Dates |
Last Update Posted: | October 7, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No individual data will be shared. Only aggregate data. |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |