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| ID | Type | Description | Link |
|---|---|---|---|
| 8716 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2018-03752 | Registry Identifier | NCI / CTRP | |
| U54CA132381-11 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Gardening Exposure | Behavioral | Assistance provided with planting and maintaining the school garden |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Beresford | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agricultural Science Center at Farmington, College of Agricultural, Consumer, and Environmental Sciences, New Mexico State University | Farmington | New Mexico | 87401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 23855020 | 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. | |
| 17044752 |
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Recruitment-eligible schools were 5 in each area. These schools were listed in random order within area. 9 schools started run-in, one school was not contacted. Two schools failed run-in, one in each area, leaving 6 schools eligible to be randomized.
In 2019, six schools completed run-in and were randomized to intervention (2) or delayed intervention (4).
Two areas of the Navajo Nation were selected. Elementary schools within 70 miles of the closest Diné College campus were identified.
Eligibility criteria for schools included within 30 miles of one of the two campuses; number of 3rd and 4th grade students between 40 and 140.
Ten schools were eligible for recruitment. 6 schools completed run-in.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | Comparison Group | For the comparison group schools, no program was provided in school year (2019-2020). After the trial, and the follow-up evaluation, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
School was unit of randomization, and unit of intervention delivery to 3rd and 4th grade students.
3rd and 4th grade student participants completed baseline. Participant was the unit analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Beginning to end of school year 2019-20 ( Baseline and ~ 8 months) | participant-time point | participant-time point |
Up to 1 year 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shirley A.A. Beresford, Principal Investigator | University of Washington, Department of Epidemiology | 206 543 9512 | beresfrd@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2020 | Aug 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Group Randomized Trial
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Interviewers were not informed of school or school assignment at follow-up
| 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 |
|
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) |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Background |
| 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. |
| 29332855 | Background | 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. |
| 34901297 | Background | 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. |
| 37791240 | Result | 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. |
| BG001 | Comparison Group | For the comparison group schools, no program was provided in school year (2019-2020). After the trial, and the follow-up evaluation, 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Understands Navajo | Count of Participants | Participants |
|
| BMI for age percentile | Mean | Standard Deviation | percentile |
|
| Overweight or Obese | Percent overweight or obese (%) | Count of Participants | Participants |
|
| Self-efficacy to eat F&V | Self-efficacy to eat Fruits and Vegetables (F&V) is a scale made up of the average of five items each with four-point Likert scale responses (I know I can, I think I can, I'm not sure I can, and I know I can't). Score range is 1 to 4. Higher scores represents higher self-efficacy. | Mean | Standard Deviation | units on a scale |
|
| AHEI Healthy Foods Score | The Healthy Foods Score is a subscale from the modified Alternative Healthy Eating Index (AHEI). Data for the modified AHEI were derived from a picture sort frequency tool, estimating frequencies of consumption of ten major food groups of the Navajo diet. Scoring published as AHEI-2010 was applied. The subscale, the Healthy Foods Score, is the sum of scores for fruits (fresh & dried), vegetables (not salad), whole grains, beans, nuts, only. The minimum value is 0 and the maximum is 36. Higher values represent a better outcome. . | Mean | Standard Deviation | units on a scale |
|
| Full self-efficacy to grow F&V at school | Percent of participants reporting "I know I can". This binary variable was derived from a question about student's confidence to grow F&V at school. The question had responses on a 4-point Likert scale. Only the "I know I can" point was used to create the binary variable for full self-efficacy to grow F&V at school. | Number | percentage of participants |
|
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|
|
|
| Primary | 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. | Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Beginning to end of school year 2019-20 ( Baseline and ~ 8 months). | participant-time point | participant-time point |
|
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|
|
| Primary | 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. | Participants were 3rd and 4th grade students responding to baseline and/or 8-month follow-up. The participant at specified time point was the unit of analysis. | Posted | Number | 95% Confidence Interval | odds ratio | Beginning to end of school year 2019-20 ( Baseline and ~ 8 months) | participant-time point | participant-time point |
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|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Comparison Group | For the comparison group schools, no program was provided in school year (2019-2020). After the trial, and the follow-up evaluation, 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. | 0 | 194 | 0 | 194 | 0 | 194 |
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Estimated differential change from baseline to follow-up from model (intervention minus control) |
| Superiority |
In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools |
| Superiority |