A School-based Gardening Obesity Intervention for Low-income Minority Children
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Detailed description: 
      Garden Leadership Coalition (GLC): The investigators will establish GLCs at each of the
      schools during the intervention phase, which will facilitate some of the school-level
      components of the intervention. These GLCs will be comprised of interested teachers, school
      staff, senior citizens, parents, and children, but these groups will be different and unique
      at each school site.

      Edible Gardens: Raised beds will be used at all garden sites, as these are easy to build,
      make garden access easy for children of all developmental levels, ensure that soils are free
      of heavy metals/contaminants, and reduce weeds in the garden area. Each school site will get
      the materials and supplies needed for garden upkeep and for teaching the lessons,.

      Curriculum: A total of 18 lessons (1 hour each) will be taught weekly over the course of the
      intervention year. The curriculum is culturally tailored to Hispanics, including culturally
      appropriate recipes, content, and activities. The curriculum is mapped on State of Texas
      Assessments of Academic Readiness (STAAR) standards for science, math, language arts, health,
      and social studies. The 9 parent lessons (each 1 hour long) will parallel the nutrition and
      gardening topics/activities taught to the children. The parent curriculum is available in
      both English and Spanish and has been culturally adapted and evaluated. The curriculum has a
      strong emphasis on the cooking components and focuses on growing and cooking foods that are
      culturally appropriate.

      School Lessons: The investigators will hire bilingual nutrition and garden educators who have
      experience teaching nutrition/ gardening programs to teach the Sprouts curriculum. Lessons
      will be taught by our educators separately to each 3rd-5th grade classroom throughout the
      school year as part of their normal school day. Although nutrition and garden educators will
      be provided to teach these lessons the first year, the schoolteachers will attend all of
      these lessons, providing the initial training for them to continue the program in subsequent
      years.

      Family Lessons at Schools: The bilingual garden/nutrition educators will also teach monthly
      Sprouts lessons throughout the school year for the families of participants at each of the
      schools.

      Delayed Intervention to Control Schools: The control schools will receive a delayed
      intervention (identical intervention as described above) in the year after the post-testing
      for that wave. Baseline and post-intervention measurements will occur in the control parents
      and students within the same time period as the intervention schools. Every control school
      will receive a garden, identical in size and structure to the intervention schools.

      Evaluation Measures: Evaluation measures will be collected 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. Most
      measures on children will be collected at the schools during normal school hours, whereas the
      blood draw will be collected on school campuses before school starts. Parent questionnaires
      will be handed out or mailed to the homes after consent is obtained. The questionnaires are
      translated into Spanish, culturally appropriate, and take ~60 minutes to complete.

      Anthropometrics, Body Fat, and Blood Pressure: For both children and parents, weight will be
      measured using a 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 the
      Center for Disease Control (CDC) age- and gender-specific values will be used. Waist
      circumferences (WC) will be measured and recorded to the nearest 0.1 cm. Body composition
      will be assessed using Bioelectrical Impedance with the Tanita Body Fat Analyzer. Blood
      pressure will be obtained in duplicate with an automatic cuff according to recommendations of
      the American Heart Association. Parental height, weight, body fat, WC, and blood pressure
      will be collected at first and last family workshop (expecting a subsample only). Therefore
      the investigators will ask self-reported height and weight in questionnaire packets.

      Dietary Intake: The questionnaire will use the School Physical Activity and Nutrition Project
      diet intake questions, which was designed to assess children's intake by food group, with a
      specific focus on fruit and fruit juices, vegetables, potatoes (including and excluding
      French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, and "added
      sugars" (in sweetened cereals, soft drinks, and sweets). The investigators will also collect
      24-hour diet recalls in a subset of children. Trained interviewers will collect three recalls
      by telephone. All recall data will be analyzed using the Nutrition Data System for Research
      (NDS-R 2012, University of Minnesota).

      Demographic and Dietary Psychosocial Measures: Demographic information including age,
      socioeconomic status and ethnicity will be obtained via a questionnaire. Parents will fill
      out a brief medical history form for their child and themselves to rule out exclusion
      criteria. Children and parents will complete questionnaires to assess preference and
      motivation for fruit and vegetable Intake, self-efficacy to garden, cook, and eat FV, food
      insecurities, and home eating environment. All parent questionnaires will be available in
      both English and Spanish, and written at a 3rd grade reading level.

      Fasting Blood Sample: Certified phlebotomists will perform the fasting blood draws on
      students first thing in the morning before school starts at the schools at baseline and at
      the end of the school year. Students with parental consent and assent will participate in the
      blood draw. Students who do not assent to participate in the blood draw will still be allowed
      to participate in the Sprouts program. Fasting blood will be drawn to assess glucose,
      insulin, lipids, and adipocytokines. Blood samples will be spun, aliquoted, frozen, and
      transported to the University of Texas (UT) campus for assaying. All children with elevated
      glucose levels (in the abnormal or Type 2 diabetes range) or elevated blood pressure will be
      contacted via telephone by Dr. Pont (Co-I on this study) to explain the test results and be
      referred immediately to a health clinic for follow-up. However, these children will still be
      allowed to participate in the study.

      Train the Trainer Workshops: At the beginning of the sustainability year, our educators will
      lead three "train the trainer" workshops. Schoolteachers will be given complete curriculum
      manuals, electronic copies of all student curriculum, and have access to all teaching
      material needed for every lesson. The workshops will connect teachers to community resources
      and will train the teachers in: structure/flow of lessons, all lesson activities/content,
      cooking/preparation skills, and available resources/materials.

      Sustainability Measures: During the Sprouts intervention and sustainability year, the
      investigators will collect pilot data on sustainability strategies being implemented in both
      the intervention and control schools. Structured interviews will be conducted with GLC
      members to document member information, leadership structure, meeting times/places, how the
      garden was designed/built, workshops offered/attended, fundraising and media events, types of
      produce harvested, produce use and distribution plans, community resources leveraged,
      barriers and future action plans. Structured interviews will be conducted with teachers,
      principals, administration staff, GLCs, and district directors and staff to evaluate various
      aspects of the program including: a) use and maintenance of garden; b) successful and
      unsuccessful components/strategies implemented to sustain program; and c) additional
      material/resources/training requested and/or needed.

      Participant Screening/Recruitment: Sixteen elementary schools will be allocated to either
      Sprouts intervention (n=8 schools) or Control group (n=8 schools). All participants and their
      parents will have to sign assent and consent forms, approved by UT-Austin's Institutional
      Review Board. Based on previous intervention work with Hispanic communities, the
      investigators anticipate ~50% of parents will consent for their children to participate, and
      their children will complete all the baseline measures. The investigators anticipate 15%
      attrition at post-intervention measurement due to parents/students moving away or being sick
      or absent from school. Based on parental participation rates in Los Angeles (LA) Sprouts, the
      investigators anticipate that 25% of parents will return parental baseline questionnaires,
      and the investigators assume a 15% attrition rate at post-testing. Based on blood draw
      participation rates in LA Sprouts, the investigators anticipate that 50% of participating
      children (n=1,200) will also participate in the blood draws at pre-intervention and 40%
      (n=960 or 60 per school) at post-intervention.

      Data Management and Analyses: Data will be merged, edited, and cleaned using system files
      created with REDCap (Research Electronic Data Capture), which is a secure web application for
      building and managing databases. The database is ideal for field data collection and will be
      accessible to all key personnel at any location. All data will be entered using the double
      data entry method.

      Summary statistics, graphical analyses, and frequency distributions will be used to describe
      the data between the intervention and control groups. Data will be transformed if needed. The
      investigators will handle missing data using two primary approaches: multiple imputation and
      full information maximum likelihood estimation methods. For Aim 1: The investigators will
      test if the children and parents participating in Sprouts compared to control will have
      increased changes in average consumption of vegetable servings per day and decreased average
      changes in BMI z-scores, waist circumference, fasting glucose, and insulin using well-known
      statistical methods for cluster randomized trials. Several analytic strategies will be
      employed to determine the effect of the intervention on vegetable intake and many of the
      other primary outcome variables. The investigators plan to conduct a two-stage nested
      analysis of variance model, which is a special case of the mixed effects linear regression
      model also known as a repeated measures analysis of variance model. The terms in the model
      include the true mean for the outcome variable, the fixed effects of the intervention arm,
      one random cluster effect (school), and the random error term. In this case, the schools
      (clusters) should be regarded as nested within the intervention arms and the students or
      parents within the school (clusters). The analytic approach for the secondary outcome
      measures (i.e., blood pressure, percent body fat, metabolic syndrome, adipocytokines, other
      dietary intake variables, and related dietary psychosocial behaviors) will involve a similar
      use of linear mixed models. For Aim 2: To test the effects of the Sprouts intervention on
      changes in vegetable intake and availability and on related dietary behaviors in the parents,
      the investigators will use similar and well-known statistical methods as described for Aim 1.
      For the Exploratory Aim, the investigators will conduct descriptive statistics on the
      collected pilot data of the sustainability strategies (qualitative and quantitative data
      obtained via structured interviews and focus groups) on both intervention and control
      schools.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention