- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672748
Growing Resilience in Wind River Indian Reservation (GR)
Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation
Study Overview
Detailed Description
The intervention is comprised of designing and providing two years of support for home gardens. Families randomized to intervention will receive the following supports and services:
- Blue Mountain Associates will host a gardening workshop to include crop planning, receipt of customized guides to the crops the family selects (these are currently in development and will be ready by 2015), and hands-on basic skills training (mid-April). CHRs and interested local healthcare providers will also participate in workshops to help them prepare for supporting gardeners.
- BMA's garden manager and assistant(s) will visit each family to help the family install a garden and will provide the family with all needed supplies (late April to early May). Based on garden harvest measures collected in the Food Dignity project and the large gardens preferred by families in the pilot, the minimum garden size will be 80 sq. ft. with at least 30 sq. ft. devoted to crops other than corn and potatoes. The manager will design at least part of each garden in a way that allows the least physically able family members to participate in gardening.
- BMA will host a Facebook support and networking group for gardeners, with ARI, BMA, and UW gardening experts providing advice as needed.
- BMA's staff will visit each gardening family at least twice more during the growing season and will be available throughout the season for phone consultations and Facebook advice. For all years, the BMA garden manager will track actual intervention support provided to each family (e.g., timing and number of visits, training and supplies provided).
The University of Wyoming research team will collect health measures before and at the end of each gardening season with gardening and control families for two years, after which the control families also receive the gardening intervention. The investigators anticipate enrolling about 100 families into the study with 400 (half adults, half children) people participating in the health measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wyoming
-
Laramie, Wyoming, United States, 82071
- University of Wyoming
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- self-identify as having one or more household members who are enrolled in a tribe
- express interest in having a food garden
- express willingness to wait to create a food garden for two years if randomized to control
- live within the boundaries of Wind River Indian Reservation, including the City of Riverton.
- if the household has two or more adults, that at least two adults in the household express willingness to participate in the semi-annual data gathering for two years.
Exclusion Criteria:
- had a home food garden plot in the previous year that is over 30 square feet in area.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gardening
Receiving two years of technical, labor and financial support in starting, growing, and harvesting from a home food garden.
|
Two years of financial and technical home gardening support for new gardeners
|
|
No Intervention: Control
The control families receive a garden as a delayed intervention after two years.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adult BMI change
Time Frame: Change from baseline at 2 years
|
With four data points, every 6 months.
Researcher-measured height (stadiometer) and Tanita body composition scale.
|
Change from baseline at 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Health change
Time Frame: Change from baseline at 2 years
|
measured by SF12 survey
|
Change from baseline at 2 years
|
|
Physical Health change
Time Frame: Change from baseline at 2 years
|
measured by SF12 survey
|
Change from baseline at 2 years
|
|
Food security change
Time Frame: Change from baseline at 2 years
|
measured by sub-set of USDA survey
|
Change from baseline at 2 years
|
|
Self-efficacy in gardening change
Time Frame: Change from baseline at 2 years
|
by survey
|
Change from baseline at 2 years
|
|
Pain change
Time Frame: Change from baseline at 2 years
|
by survey
|
Change from baseline at 2 years
|
|
Blood pressure change
Time Frame: Change from baseline at 2 years
|
researcher-measured with bp monitor
|
Change from baseline at 2 years
|
|
hand strength change
Time Frame: Change from baseline at 2 years
|
researcher-measured with dynamometer
|
Change from baseline at 2 years
|
|
waist circumference change
Time Frame: Change from baseline at 2 years
|
researcher-measured with spring-loaded tape measure
|
Change from baseline at 2 years
|
|
beta-carotene change
Time Frame: Change from baseline at 2 years
|
whole blood draw and assay
|
Change from baseline at 2 years
|
|
Hb A1C change
Time Frame: Change from baseline at 2 years
|
whole blood draw and assay
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Change from baseline at 2 years
|
|
cholesterol change
Time Frame: Change from baseline at 2 years
|
whole blood draw and assay
|
Change from baseline at 2 years
|
|
triglycerides change
Time Frame: Change from baseline at 2 years
|
whole blood draw and assay
|
Change from baseline at 2 years
|
|
vitamin D change
Time Frame: Change from baseline at 2 years
|
whole blood draw and assay
|
Change from baseline at 2 years
|
|
child BMI z-score change
Time Frame: Change from baseline at 2 years
|
Change from baseline at 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine M Porter, PhD, University of Wyoming
Publications and helpful links
General Publications
- Naschold F, Porter CM. BMI Status and Trends among Native American Family Members Participating in the Growing Resilience Home Garden Study. Curr Dev Nutr. 2022 Jun 3;6(7):nzac100. doi: 10.1093/cdn/nzac100. eCollection 2022 Jul.
- Porter CM, Wechsler AM, Hime SJ, Naschold F. Adult Health Status Among Native American Families Participating in the Growing Resilience Home Garden Study. Prev Chronic Dis. 2019 Aug 22;16:E113. doi: 10.5888/pcd16.190021.
- Porter CM, Wechsler AM, Naschold F, Hime SJ, Fox L. Assessing health impacts of home food gardens with Wind River Indian Reservation families: protocol for a randomised controlled trial. BMJ Open. 2019 Apr 3;9(4):e022731. doi: 10.1136/bmjopen-2018-022731.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HL126666-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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