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Completed

NCT Number: NCT03778021

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

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.

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Eating Behavior Feeding Behavior Health Behavior

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Gardening Exposure

Behavioral

Assistance provided with planting and maintaining the school garden

Healthy Eating and Gardening Curriculum

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

Primary outcomes

  1. Estimated Change in Child Fruit & Vegetable Self-efficacy

    Time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)

    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.

  2. Estimated Change in AHEI Healthy Foods Score

    Time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months).

    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.

  3. Estimated Ratio of Full Self-efficacy to Grow F&V at School

    Time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)

    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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: Yeego!

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2018
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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