Clinical trial NCT03778021: Yeego! Healthy Eating & Gardening School-Based Randomized Controlled Trial
Official title: Engaging Navajo Elementary Schools in Randomized Controlled Trial of Yeego! Healthy Eating & Gardening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Health Behavior
Eating Behavior
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2018-12-19
Enrollment: 294
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group Randomized Trial
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimated Change in Child Fruit & Vegetable Self-efficacy
timeFrame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)
measure: Estimated Change in AHEI Healthy Foods Score
timeFrame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months).
measure: Estimated Ratio of Full Self-efficacy to Grow F&V at School
timeFrame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Agricultural Science Center at Farmington, College of Agricultural, Consumer, and Environmental Sciences, New Mexico State University
state: New Mexico
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Shirley Beresford
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lombard KA, Beresford SAA, Ornelas IJ, Jim J, Bauer M, Nez F. Where health and horticulture intersect: A Navajo wellness collaboration. HortScience. 2015;50(9):S360.
citation: Lombard KA, Beresford SA, Ornelas IJ, Topaha C, Becenti T, Thomas D, Vela JG. Healthy gardens/healthy lives: Navajo perceptions of growing food locally to prevent diabetes and cancer. Health Promot Pract. 2014 Mar;15(2):223-31. doi: 10.1177/1524839913492328. Epub 2013 Jul 12.
citation: Lombard KA, Forster-Cox S, Smeal D, O'Neill MK. Diabetes on the Navajo nation: what role can gardening and agriculture extension play to reduce it? Rural Remote Health. 2006 Oct-Dec;6(4):640. Epub 2006 Oct 16.
citation: Ornelas IJ, Deschenie D, Jim J, Bishop S, Lombard K, Beresford SA. Yeego Gardening! A Community Garden Intervention to Promote Health on the Navajo Nation. Prog Community Health Partnersh. 2017;11(4):417-425. doi: 10.1353/cpr.2017.0049.
citation: Ornelas IJ, Rudd K, Bishop S, Deschenie D, Brown E, Lombard K, Beresford SAA. Engaging School and Family in Navajo Gardening for Health: Development of the Yeego Intervention to Promote Healthy Eating among Navajo Children. Health Behav Policy Rev. 2021 May;8(3):212-222. doi: 10.14485/HBPR.8.3.3. Epub 2021 May 1.
citation: Beresford SAA, Ornelas IJ, Bauer MC, Garrity GA, Bishop SK, Francis B, Rillamas-Sun E, Garcia LV, Vecenti FSA, Lombard KA. Group Randomized Trial of Healthy Eating and Gardening Intervention in Navajo Elementary Schools (Yeego!). AJPM Focus. 2022 Sep 16;1(2):100033. doi: 10.1016/j.focus.2022.100033. eCollection 2022 Dec.