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

NCT ID: NCT03778021

Last Updated: 2022-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2021-08-31

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.

Conditions

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Dietary Habits Health Behavior Eating Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group Randomized Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Interviewers were not informed of school or school assignment at follow-up

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Behavioral Gardening Exposure

Intervention Type BEHAVIORAL

Assistance provided with planting and maintaining the school garden

Healthy Eating and Gardening Curriculum

Intervention Type BEHAVIORAL

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

Comparison Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral Gardening Exposure

Assistance provided with planting and maintaining the school garden

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Shirley Beresford

Professor, Cancer Prevention Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shirley Beresford

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Agricultural Science Center at Farmington, College of Agricultural, Consumer, and Environmental Sciences, New Mexico State University

Farmington, New Mexico, United States

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23855020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17044752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29332855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34901297 (View on PubMed)

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.

Reference Type RESULT
PMID: 37791240 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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8716

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2018-03752

Identifier Type: REGISTRY

Identifier Source: secondary_id

U54CA132381-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1001953

Identifier Type: -

Identifier Source: org_study_id