Yeego! Healthy Eating & Gardening School-Based Randomized Controlled Trial

Study Overview
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Brief Summary
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In this study, one year changes in healthy eating and gardening behaviors associated with the intervention were estimated using a group randomized controlled trial design, with the comparison arm receiving a delayed intervention in the following school year.

Detailed Description
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The small randomized controlled trial of an intensive curriculum and school garden intervention was implemented in elementary schools in two communities (Shiprock and Tsaile). The study began in year 1 with a period of engagement and recruitment of schools in each community; with the goal of recruiting three schools in each community to complete the run-in phase. The run-in period included time for greater engagement with the school community, an assessment of the potential garden site and an assessment of evaluation readiness. Depending on whether three schools in the community qualify for the study at the end of run-in, or only two schools per community, it was planned to randomize three or two schools to intervention or delayed intervention status in each community. Six schools were randomized, two intervention schools and 4 comparison (delayed intervention) schools. Baseline data collection was conducted at the beginning of the school year 2019-2020 in Year 2 with 3rd and 4th grade children. Students in the intervention schools received the curriculum and school garden during that academic school year (Study Year 2). At the end of the school year, 8-month follow-up assessment was conducted. The main evaluation period is between baseline and 8-month follow-up, and the statistical analysis methods estimate the differential change in outcome measures (healthy eating and gardening). Not part of the clinical trial, the study continued in the next school year (2020-2021). At the beginning of Study Year 3, the comparison schools were scheduled to receive the delayed intervention. During Study Year 3, it was planned to conduct quarterly community gardening workshops for adult family members in all schools. Due to the COVID-19 pandemic, a series of 10 video workshops were produced and made available via YouTube. Attendance/Views were tracked. A final assessment survey was conducted at the end of that school year (in 2021) in all 6 schools to allow additional descriptive analyses.

Official Title
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Engaging Navajo Elementary Schools in Randomized Controlled Trial of Yeego! Healthy Eating & Gardening

Conditions
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Dietary Habits, Health Behavior, Eating Behavior

Intervention / Treatment
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* Behavioral: Behavioral Gardening Exposure
* Behavioral: Healthy Eating and Gardening Curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elementary schools in Tsaile and Shiprock will have been in existence for at least three years, school size (have between 40 to 100 students in grades 3 and 4 combined), have more than two-thirds Navajo students and satisfy a garden site checklist that can overcome garden barriers (e.g. have access to water) Assessment is restricted to Male/female students in grades 3 and 4 attending school in either Tsaile or Shiprock Exclusion criteria: Students in grades other than 3rd or 4th are not eligible for assessment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group Randomized Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Intervention schools receive a raised bed school garden and a curriculum of healthy eating and gardening lessons. 3rd and 4th grade students in the intervention group received the curriculum and exposure to the school garden during the academic school year (2019-20) Behavioral Gardening Exposure: Assistance provided with planting and maintaining the school garden Healthy Eating and Gardening Curriculum: 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season. | Behavioral: Behavioral Gardening Exposure<br>* Assistance provided with planting and maintaining the school garden<br>Behavioral: Healthy Eating and Gardening Curriculum<br>* 14 to 17 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season<br>|
| No Intervention: Comparison Group<br>For the comparison group schools, no program was provided in school year (2019-2020). After the trial, and the follow-up evaluation, in school year 2020-2021 comparison schools received delayed intervention components as follows: School gardens were created during the 2020-2021 school year (subject to delays due to pandemic restrictions). Curriculum materials were supplied to the school for use by teachers as they saw fit, after pandemic restrictions were lifted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Change in Child Fruit & Vegetable Self-efficacy | Self-efficacy for eating F&V score is average of responses to five 4-point Likert scale questions. Higher score is higher self-efficacy. Score range is 1 to 4. Change in self-efficacy is based on a model that uses all available data (from baseline and 8-month follow-up). The unit of analysis is participant-timepoint. The analysis accounts for nesting within schools. Using a repeated measures linear mixed model analysis, the results are estimated change in self-efficacy score from baseline to 8-month follow-up, contrasting intervention group to comparison group. From the model, the estimated change in scores from baseline to 8-month follow-up ranged from 0.14 to 0.62. The unit of measure is score on a scale. The results show the least squares estimate of change in that score. Positive estimated change in score indicates self-efficacy increased from baseline to follow-up. Positive differential change indicates that intervention group change was greater than comparison group. | Beginning to end of school year 2019-20 ( Baseline and   8 months) | 
| Estimated Change in AHEI Healthy Foods Score | The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data were derived from a picture sort frequency tool estimating consumption frequencies of ten major food groups of the Navajo diet. Scoring used the published AHEI-2010. The subscale is the sum of scores for fruits (fresh & dried), vegetables (not salad), whole grains, beans, nuts, only. Values range from 0 to 36. Higher values represent a better outcome. Change in Score is based on a model that uses all available data (from baseline and 8-month follow-up). The model is from a repeated measures linear mixed model analysis. Change in Healthy Foods score is estimated from baseline to 8-mth follow-up, contrasting intervention group to comparison group. The change scores ranged from -0.63 to 3.66. Positive estimated change indicates an increase from baseline to follow-up. Positive differential change indicates that intervention group change was greater than comparison group change. | Beginning to end of school year 2019-20 ( Baseline and   8 months). | 
| Estimated Ratio of Full Self-efficacy to Grow F&V at School | Measure derived from Percent of participants at each time point reporting I know I can. Using generalized mixed models, specifying a binomial distribution, accounting for nesting within schools, the Odds ratio of 8-month follow-up to baseline percent reporting I know I can was estimated for both intervention and comparison groups. The overall range in these odds ratios was 0.95 to 3.63 . The contrast of intervention group to comparison group was also an odds ratio. | Beginning to end of school year 2019-20 ( Baseline and   8 months) |