Clinical trial NCT02672748: Growing Resilience in Wind River Indian Reservation
Official title: Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Diabetes
Keywords: garden
Native American
BMI
Emotional health
Physical health
Lead sponsor: University of Wyoming
Sponsor class: OTHER
Collaborators: name: Blue Mountain Associates, Incorporated
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Eastern Shoshone Tribal Health
name: Action Resources International
name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
name: Wind River Development Fund (WRDF)
First posted: 2016-02-03
Enrollment: 338
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Adult BMI change
timeFrame: Change from baseline at 2 years
Secondary outcomes:
measure: Mental Health change
timeFrame: Change from baseline at 2 years
measure: Physical Health change
timeFrame: Change from baseline at 2 years
measure: Food security change
timeFrame: Change from baseline at 2 years
measure: Self-efficacy in gardening change
timeFrame: Change from baseline at 2 years
measure: Pain change
timeFrame: Change from baseline at 2 years
measure: Blood pressure change
timeFrame: Change from baseline at 2 years
measure: hand strength change
timeFrame: Change from baseline at 2 years
measure: waist circumference change
timeFrame: Change from baseline at 2 years
measure: beta-carotene change
timeFrame: Change from baseline at 2 years
measure: Hb A1C change
timeFrame: Change from baseline at 2 years
measure: cholesterol change
timeFrame: Change from baseline at 2 years
measure: triglycerides change
timeFrame: Change from baseline at 2 years
measure: vitamin D change
timeFrame: Change from baseline at 2 years
measure: child BMI z-score change
timeFrame: Change from baseline at 2 years
Other outcomes:
Locations:
city: Laramie
country: United States
facility: University of Wyoming
state: Wyoming
Study officials:
affiliation: University of Wyoming
name: Christine M Porter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.