Dietary HabitsYeego!NCT03778021
Yeego! Healthy Eating & Gardening School-Based Randomized Controlled Trial
A study testing Behavioral Gardening Exposure and Healthy Eating and Gardening Curriculum in people with Dietary Habits and Health Behavior, run by Fred Hutchinson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Dietary Habits, Health Behavior, Eating Behavior
- What is being tested?
- Behavioral Gardening Exposure and Healthy Eating and Gardening Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Aug 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Students in grades other than 3rd or 4th are not eligible for assessment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Agricultural Science Center at Farmington, College of Agricultural, Consumer, and Environmental Sciences, New Mexico State University
Farmington, New Mexico, 87401
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Engaging Navajo Elementary Schools in Randomized Controlled Trial of Yeego! Healthy Eating & Gardening
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.
Read the 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
- Dietary Habits, Health Behavior, Eating Behavior
- Being tested
- Behavioral Gardening Exposure, Healthy Eating and Gardening Curriculum
- Medical subject headings
- Feeding Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Gardening ExposureBehavioural
Assistance provided with planting and maintaining the school garden
Healthy Eating and Gardening CurriculumBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Gardening Exposure; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Aug 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group Randomized Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Shirley Beresford, Fred Hutchinson Cancer Center
- Investigators
- Shirley Beresford, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778021
- Sponsor's protocol ID
- RG1001953
- Other IDs
- 8716, NCI-2018-03752, U54CA132381-11, P30CA015704
- Acronym
- Yeego!
- Status last verified
- Nov 2022
- First submitted
- 14 Dec 2018
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 23855020Lombard 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.
PubMed 17044752Ornelas 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.
PubMed 29332855Ornelas 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.
PubMed 34901297Beresford 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.
PubMed 37791240
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Navajo Elementary Schools in Randomized Controlled Trial of Yeego! Healthy Eating & Gardening
- ClinicalTrials.gov ID
- NCT03778021
- Acronym / sponsor ID
- Yeego! / RG1001953
- Conditions
- Dietary Habits, Health Behavior, Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Behavioral Gardening Exposure, Behavioral: Healthy Eating and Gardening CurriculumIntervention 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. |
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Students in grades other than 3rd or 4th are not eligible for assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Gardening ExposureAssistance provided with planting and maintaining the school garden | Behavioural | Intervention Group |
| Healthy 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 | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundLombard 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: PubMed 23855020Lombard 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.
- Background: PubMed 17044752Lombard 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.
- Background: PubMed 29332855Ornelas 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.
- Background: PubMed 34901297Ornelas 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.
- Results publication: PubMed 37791240Beresford 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Beresford principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Gardening Exposure and Healthy Eating and Gardening Curriculum in people with Dietary Habits and Health Behavior, run by Fred Hutchinson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Change in Child Fruit & Vegetable Self-efficacy (time frame: Beginning to end of school year 2019-20 ( Baseline and ~ 8 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03778021, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.