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A School-based Gardening Obesity Intervention for Low-income Minority Children

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ClinicalTrials.gov Identifier: NCT02668744
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
The University of Texas Health Science Center, Houston
Seton Healthcare Family
Texas AgriLife Extension Service
Information provided by (Responsible Party):
Jaimie N. Davis, University of Texas at Austin

Brief Summary:
The investigators recently completed an NIH R21 grant, which was a randomized controlled trial (RCT) to test the effects of a gardening, nutrition, and cooking program in 375 low-income Hispanic students living in Los Angeles. Preliminary results from this study show that intervention compared to the control students have reductions in BMI parameters and waist circumference, increases in daily intake of dietary fiber and vegetables, and improved lipid profiles. The investigators want to expand and replicate this study by: a) using a cluster randomized school design; b) implementing the program during school hours; c) increasing sample size; d) lengthening the intervention period to one school year; e) collecting comprehensive metabolic measurements on the child; f) enhancing family workshops; g) collecting more parental data; and h) developing and evaluating sustainability strategies. Thus, the overall goal of this project is to test the effects of a large school-based gardening, nutrition, and cooking RCT (called "Sprouts") on dietary intake, dietary-related behaviors, obesity, and related metabolic disorders in low-income Hispanic youth and their families in Central Texas. Sixteen elementary schools will be randomized to either: 1) Sprouts intervention or 2) Control (delayed intervention). At each intervention school, the investigators will build edible gardens; form and train Garden Leadership Coalitions (GLCs); teach 20 Sprouts in-school lessons to the students; and teach nine family-based Sprouts lessons throughout school year. The following measures will be obtained for students at baseline and post-intervention: height, weight, BMI, waist circumference, body composition (via bioimpedance), blood pressure, glucose, insulin, and lipids (via voluntary fasting blood draws), dietary intake, and related psychosocial behaviors (e.g., preference/motivation/self-efficacy to eat FV). The investigators will also measure anthropometrics, dietary intake, and related dietary psychosocial variables on the parents at baseline and post-intervention. After the intervention year, the investigators will provide a series of training workshops and resources to the GLCs and schoolteachers to sustain the Sprouts program in subsequent years. The investigators will measure the sustainability employed by each school by process logs/surveys, structured interviews, and school observations.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : March 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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Katharine B Nikah, MPH 512-471-2809 katienikah@utexas.edu
Contact: Matthew Landry, BA 512-471-2809 matthewlandry@utexas.edu

Locations
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United States, Texas
Barbara Jordan Elementary Completed
Austin, Texas, United States, 78724
Decker Elementary Completed
Austin, Texas, United States, 78724
Oak Meadows Elementary Completed
Austin, Texas, United States, 78724
Pleasant Hill Elementary Completed
Austin, Texas, United States, 78745
Casey Elementary Recruiting
Austin, Texas, United States, 78748
Contact: Lina Villareal    512-841-6900      
Hart Elementary Completed
Austin, Texas, United States, 78753
McBee Elementary Recruiting
Austin, Texas, United States, 78758
Contact: Maggie De La Rosa    512-841-2500      
Booker T. Washington Completed
Elgin, Texas, United States, 78621
Elgin Elementary Completed
Elgin, Texas, United States, 78621
Neidig Elementary Recruiting
Elgin, Texas, United States, 78621
Contact: April Wallace       awallace@elginisd.net   
Carver Elementary Completed
Georgetown, Texas, United States, 78626
Mitchell Elementary Completed
Georgetown, Texas, United States, 78626
Pickett Elementary Completed
Georgetown, Texas, United States, 78626
Purl Elementary Recruiting
Georgetown, Texas, United States, 78626
Contact: Denisse Baldwin       baldwinde@georgetownisd.org   
Callison Elementary Completed
Round Rock, Texas, United States, 78664
Voigt Elementary Completed
Round Rock, Texas, United States, 78664
Sponsors and Collaborators
University of Texas at Austin
National Heart, Lung, and Blood Institute (NHLBI)
The University of Texas Health Science Center, Houston
Seton Healthcare Family
Texas AgriLife Extension Service
Investigators
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Principal Investigator: Jaimie N Davis, PhD University of Texas at Austin

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Responsible Party: Jaimie N. Davis, Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02668744     History of Changes
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: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data will be shared. Only aggregate data.

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms