Growing Resilience in Wind River Indian Reservation (GR)
Primary Purpose
Obesity, Overweight, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Garden
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring garden, Native American, BMI, Emotional health, Physical health
Eligibility Criteria
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.
Sites / Locations
- University of Wyoming
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gardening
Control
Arm Description
Receiving two years of technical, labor and financial support in starting, growing, and harvesting from a home food garden.
The control families receive a garden as a delayed intervention after two years.
Outcomes
Primary Outcome Measures
Adult BMI change
With four data points, every 6 months. Researcher-measured height (stadiometer) and Tanita body composition scale.
Secondary Outcome Measures
Mental Health change
measured by SF12 survey
Physical Health change
measured by SF12 survey
Food security change
measured by sub-set of USDA survey
Self-efficacy in gardening change
by survey
Pain change
by survey
Blood pressure change
researcher-measured with bp monitor
hand strength change
researcher-measured with dynamometer
waist circumference change
researcher-measured with spring-loaded tape measure
beta-carotene change
whole blood draw and assay
Hb A1C change
whole blood draw and assay
cholesterol change
whole blood draw and assay
triglycerides change
whole blood draw and assay
vitamin D change
whole blood draw and assay
child BMI z-score change
Full Information
NCT ID
NCT02672748
First Posted
November 9, 2015
Last Updated
July 18, 2023
Sponsor
University of Wyoming
Collaborators
Blue Mountain Associates, Incorporated, National Heart, Lung, and Blood Institute (NHLBI), Eastern Shoshone Tribal Health, Action Resources International, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), Wind River Development Fund (WRDF)
1. Study Identification
Unique Protocol Identification Number
NCT02672748
Brief Title
Growing Resilience in Wind River Indian Reservation
Acronym
GR
Official Title
Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wyoming
Collaborators
Blue Mountain Associates, Incorporated, National Heart, Lung, and Blood Institute (NHLBI), Eastern Shoshone Tribal Health, Action Resources International, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), Wind River Development Fund (WRDF)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Growing Resilience research leverages reservation-based assets of land, family, culture, and front-line tribal health organizations to develop and evaluate home food gardens as a family-based health promotion intervention to reduce disparities suffered by Native Americans in nearly every measure of health. Home gardening interventions show great promise for enabling families to improve their health, and this study aims to fulfill that promise with university and Wind River Indian Reservation partners. The investigators will develop an empowering, scalable, and sustainable family-based health promotion intervention with, by, and for Native American families and conduct the first RCT to assess the health impacts of home gardens.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Diabetes
Keywords
garden, Native American, BMI, Emotional health, Physical health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The primary data analyst will not know which set of results are from people in the gardening vs. the control condition.
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gardening
Arm Type
Experimental
Arm Description
Receiving two years of technical, labor and financial support in starting, growing, and harvesting from a home food garden.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control families receive a garden as a delayed intervention after two years.
Intervention Type
Other
Intervention Name(s)
Garden
Intervention Description
Two years of financial and technical home gardening support for new gardeners
Primary Outcome Measure Information:
Title
Adult BMI change
Description
With four data points, every 6 months. Researcher-measured height (stadiometer) and Tanita body composition scale.
Time Frame
Change from baseline at 2 years
Secondary Outcome Measure Information:
Title
Mental Health change
Description
measured by SF12 survey
Time Frame
Change from baseline at 2 years
Title
Physical Health change
Description
measured by SF12 survey
Time Frame
Change from baseline at 2 years
Title
Food security change
Description
measured by sub-set of USDA survey
Time Frame
Change from baseline at 2 years
Title
Self-efficacy in gardening change
Description
by survey
Time Frame
Change from baseline at 2 years
Title
Pain change
Description
by survey
Time Frame
Change from baseline at 2 years
Title
Blood pressure change
Description
researcher-measured with bp monitor
Time Frame
Change from baseline at 2 years
Title
hand strength change
Description
researcher-measured with dynamometer
Time Frame
Change from baseline at 2 years
Title
waist circumference change
Description
researcher-measured with spring-loaded tape measure
Time Frame
Change from baseline at 2 years
Title
beta-carotene change
Description
whole blood draw and assay
Time Frame
Change from baseline at 2 years
Title
Hb A1C change
Description
whole blood draw and assay
Time Frame
Change from baseline at 2 years
Title
cholesterol change
Description
whole blood draw and assay
Time Frame
Change from baseline at 2 years
Title
triglycerides change
Description
whole blood draw and assay
Time Frame
Change from baseline at 2 years
Title
vitamin D change
Description
whole blood draw and assay
Time Frame
Change from baseline at 2 years
Title
child BMI z-score change
Time Frame
Change from baseline at 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine M Porter, PhD
Organizational Affiliation
University of Wyoming
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wyoming
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82071
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be made available to each individual participant, but otherwise only the data summaries will be made available to non-partner parties unless individually arranged and approved by the IRB and project Community Advisory Board. The Northern Arapaho and the Eastern Shoshone tribes co-own the data with the research teams (and Eastern Shoshone Tribal Health and Northern Arapaho Tribal Health are entities of the tribal governments).
Citations:
PubMed Identifier
35898313
Citation
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.
Results Reference
derived
PubMed Identifier
31441769
Citation
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.
Results Reference
derived
PubMed Identifier
30948560
Citation
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.
Results Reference
derived
Links:
URL
http://www.growingresilience.org
Description
website for the project
Learn more about this trial
Growing Resilience in Wind River Indian Reservation
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