Clinical Trials Directory

Trials / Completed

CompletedNCT03778021

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
294 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBehavioral Gardening ExposureAssistance provided with planting and maintaining the school garden
BEHAVIORALHealthy Eating and Gardening Curriculum14 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

Timeline

Start date
2019-08-05
Primary completion
2021-08-31
Completion
2021-08-31
First posted
2018-12-19
Last updated
2022-12-23
Results posted
2022-12-23

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03778021. Inclusion in this directory is not an endorsement.