NCT03778021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

December 14, 2018

Results QC Date

August 30, 2022

Last Update Submit

November 29, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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 ExposureBehavioral: Healthy Eating and Gardening Curriculum

Comparison Group

NO INTERVENTION

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.

Interventions

Assistance provided with planting and maintaining the school garden

Intervention Group

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 Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Students in grades other than 3rd or 4th are not eligible for assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Farmington, New Mexico, 87401, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (6)

  • 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.

    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.

    PMID: 23855020BACKGROUND
  • 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.

    PMID: 17044752BACKGROUND
  • 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.

    PMID: 29332855BACKGROUND
  • 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.

    PMID: 34901297BACKGROUND
  • 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.

MeSH Terms

Conditions

Feeding BehaviorHealth Behavior

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Limitations and Caveats

The group randomized trial was small, in that only six schools were enrolled and randomized. Not all 3rd and 4th graders participated in the baseline assessment. Not all students completing baseline also completed follow-up. Only six of the 11 standard components of AHEI could be estimated. Dietary behaviors were assessed using self-efficacy for F\&V, and metrics based on the picture sort tool. Neither of these methods is considered as reliable as the 24 hour recall.

Results Point of Contact

Title
Shirley A.A. Beresford, Principal Investigator
Organization
University of Washington, Department of Epidemiology

Study Officials

  • Shirley Beresford

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Interviewers were not informed of school or school assignment at follow-up
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group Randomized Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Cancer Prevention Program

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

August 5, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

December 23, 2022

Results First Posted

December 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations