Trial Outcomes & Findings for Yeego! Healthy Eating & Gardening School-Based Randomized Controlled Trial (NCT NCT03778021)

Last Updated: 2022-12-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

294 participants

Primary outcome timeframe

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

Results posted on

2022-12-23

Participant Flow

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.

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).

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	100 2	194 4
Overall Study COMPLETED	72 2	141 4
Overall Study NOT COMPLETED	28 0	53 0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Student failed to respond to follow-up survey	28	53

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=100 Participants 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 n=194 Participants 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.	Total n=294 Participants Total of all reporting groups
Age, Continuous	8.6 Years STANDARD_DEVIATION 0.7 • n=5 Participants	8.7 Years STANDARD_DEVIATION 0.9 • n=7 Participants	8.7 Years STANDARD_DEVIATION 0.8 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	109 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	85 Participants n=7 Participants	143 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	91 Participants n=5 Participants	175 Participants n=7 Participants	266 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants	194 Participants n=7 Participants	294 Participants n=5 Participants
Understands Navajo	49 Participants n=5 Participants	119 Participants n=7 Participants	168 Participants n=5 Participants
BMI for age percentile	73.1 percentile STANDARD_DEVIATION 31.2 • n=5 Participants	69.7 percentile STANDARD_DEVIATION 29.8 • n=7 Participants	70.9 percentile STANDARD_DEVIATION 30.3 • n=5 Participants
Overweight or Obese	50 Participants n=5 Participants	83 Participants n=7 Participants	133 Participants n=5 Participants
Self-efficacy to eat F&V	3.2 units on a scale STANDARD_DEVIATION 0.65 • n=5 Participants	3.4 units on a scale STANDARD_DEVIATION 0.57 • n=7 Participants	3.3 units on a scale STANDARD_DEVIATION 0.60 • n=5 Participants
AHEI Healthy Foods Score	16.9 units on a scale STANDARD_DEVIATION 5.8 • n=5 Participants	17.8 units on a scale STANDARD_DEVIATION 6.4 • n=7 Participants	17.5 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants
Full self-efficacy to grow F&V at school	49.0 percentage of participants n=5 Participants	40.0 percentage of participants n=7 Participants	43.2 percentage of participants n=5 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Intervention Group n=172 participant-time point 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 n=335 participant-time point 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.
Estimated Change in Child Fruit & Vegetable Self-efficacy	0.47 score on a scale Standard Error 0.08	0.24 score on a scale Standard Error 0.05

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=172 participant-time point 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 n=335 participant-time point 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.
Estimated Change in AHEI Healthy Foods Score	1.98 score on a scale Standard Error 0.85	0.58 score on a scale Standard Error 0.61

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=172 participant-time point 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 n=335 participant-time point 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.
Estimated Ratio of Full Self-efficacy to Grow F&V at School	1.92 odds ratio Interval 1.02 to 3.63	1.48 odds ratio Interval 0.95 to 2.31

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparison Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shirley A.A. Beresford, Principal Investigator

University of Washington, Department of Epidemiology

Phone: 206 543 9512

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place