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

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Dietary Habits; Eating Behavior; Health Behavior

Treatments: Behavioral: Healthy Eating and Gardening Curriculum; Behavioral: Behavioral Gardening Exposure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03778021

RG1001953

8716 (Other Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

NCI-2018-03752 (Registry Identifier)

U54CA132381-11 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 294 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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294 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Eating and Gardening Curriculum

Behavioral: Behavioral Gardening Exposure

Comparison Group

No Intervention group

Description:

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.