ClinicalTrials.gov
ClinicalTrials.gov Menu

Yeego! Healthy Eating & Gardening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03778021
Recruitment Status : Not yet recruiting
First Posted : December 18, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief Summary:
In this study we will estimate changes in healthy eating and gardening behaviors associated with the intervention using a randomized controlled trial design, with the comparison arm receiving a delayed intervention in the following school year.

Condition or disease Intervention/treatment Phase
Dietary Habits Health Behavior Eating Behavior Behavioral: Behavioral Gardening Exposure Behavioral: Healthy Eating and Gardening Curriculum Behavioral: Family Workshops Not Applicable

Detailed Description:
The small randomized controlled trial of an intensive curriculum and school garden intervention will be implemented in elementary schools in two communities (Shiprock and Tsaile). The study will begin 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 start the run-in phase. The run-in period will include time for greater engagement with the school community, an assessment of the potential garden site and an assessment of evaluation readiness. Depending on whether all three schools in the community qualify for the study at the end of run-in, or only two schools per community, we will randomize three or two schools to intervention or delayed intervention status in each community. We will have either two intervention schools and 4 delayed intervention schools, or 2 intervention schools and 2 delayed intervention schools, depending on the run-in information. We will conduct baseline data collection (T1) at the beginning of the school year in Year 2 with both children and parents. Students in the intervention group will receive the curriculum and school garden during that academic school year. At the end of the school year, we will conduct the T2 assessment in children and parents. The main evaluation period is between T1 and f2, and the statistical analysis methods refer to the T2 versus T1 change in outcome measures (healthy eating and gardening). After that, at the beginning of the next school year (Year 3), the delayed intervention schools will receive the intervention. During Year 3, we will also conduct quarterly community gardening workshops for adult family members in all schools. Attendance at these will be tracked. A final assessment (T3) will be conducted at the end of the second school year in all the randomized schools to describe behaviors in children and parents over time, using a quasiexperimental design that estimates change in the delayed intervention group between T2 and T3, attributable in part to the delayed intervention.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Engaging Navajo Elementary Schools in Randomized Controlled Trial of Yeego! Healthy Eating & Gardening
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Intervention Group
Students in the intervention group will receive the curriculum and school garden during the second academic school year (Year 2)
Behavioral: Behavioral Gardening Exposure
Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols

Behavioral: Healthy Eating and Gardening Curriculum
Attend 12 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: Family Workshops
During Year 3, quarterly healthy eating and gardening workshops for family and community members to attend

Active Comparator: Delayed Intervention Group
For the delayed intervention group schools, students will receive the intervention at the beginning of Year 3
Behavioral: Behavioral Gardening Exposure
Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols

Behavioral: Healthy Eating and Gardening Curriculum
Attend 12 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: Family Workshops
During Year 3, quarterly healthy eating and gardening workshops for family and community members to attend




Primary Outcome Measures :
  1. Child healthy eating behaviors [ Time Frame: Up to 2 years ]
    Assess dietary intake in elementary school age children by utilizing the picture sort method to estimate the frequency of eating foods that comprise ten major food groupings of the Navajo diet

  2. Child gardening participation [ Time Frame: Up to 2 years ]
    Survey children to see if they have a garden at home, and if so how often they do gardening activities there

  3. Child Gardening Self-efficacy [ Time Frame: Up to 2 years ]
    Survey children to identify how confident they are in their abilities to perform gardening behaviors, utilizing six-item likert scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children ages 8-12
  • Adults ages 21-75
  • 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.9. have access to water)
  • Assessment is restricted to Male/female students in grades 3 and 4 attending, attending school in either Tsaile or Shiprock and one family member (Navajo adult aged 18 and older) for each child.

Exclusion Criteria:

  • Family member- child dyads neither of which are Navajo
  • Family member/child dyads not expected to stay at the recruited Tsaile or Shiprock elementary school for the whole school year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778021


Contacts
Contact: Shirley Beresford 206-667-4793 sberesfo@fredhutch.org

Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Shirley Beresford         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Shirley Beresford Fred Hutch/University of Washington Cancer Consortium

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03778021     History of Changes
Other Study ID Numbers: RG1001953
8716 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No