Growing Resilience in Wind River Indian Reservation

Obesity Clinical Trial

— GR  

Official title:

Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672748
• Other study ID #: R01HL126666-01A1
• Secondary ID: R01HL126666-01A1
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: University of Wyoming
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. 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.

2. 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.

3. BMA will host a Facebook support and networking group for gardeners, with ARI, BMA, and UW gardening experts providing advice as needed.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: March 31, 2023
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Obesity
• Overweight

Intervention

Other:
• Garden
Two years of financial and technical home gardening support for new gardeners

Locations

Country	Name	City	State
United States	University of Wyoming	Laramie	Wyoming

Sponsors (8)

Lead Sponsor	Collaborator
University of Wyoming	Action Resources International, Blue Mountain Associates, Incorporated, Eastern Shoshone Tribal Health, National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), Wind River Development Fund (WRDF)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult BMI change	With four data points, every 6 months. Researcher-measured height (stadiometer) and Tanita body composition scale.	Change from baseline at 2 years
Secondary	Mental Health change	measured by SF12 survey	Change from baseline at 2 years
Secondary	Physical Health change	measured by SF12 survey	Change from baseline at 2 years
Secondary	Food security change	measured by sub-set of USDA survey	Change from baseline at 2 years
Secondary	Self-efficacy in gardening change	by survey	Change from baseline at 2 years
Secondary	Pain change	by survey	Change from baseline at 2 years
Secondary	Blood pressure change	researcher-measured with bp monitor	Change from baseline at 2 years
Secondary	hand strength change	researcher-measured with dynamometer	Change from baseline at 2 years
Secondary	waist circumference change	researcher-measured with spring-loaded tape measure	Change from baseline at 2 years
Secondary	beta-carotene change	whole blood draw and assay	Change from baseline at 2 years
Secondary	Hb A1C change	whole blood draw and assay	Change from baseline at 2 years
Secondary	cholesterol change	whole blood draw and assay	Change from baseline at 2 years
Secondary	triglycerides change	whole blood draw and assay	Change from baseline at 2 years
Secondary	vitamin D change	whole blood draw and assay	Change from baseline at 2 years
Secondary	child BMI z-score change		Change from baseline at 2 years

External Links

•   website for the project