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Growing Resilience in Wind River Indian Reservation (GR)

This study is currently recruiting participants.
Verified May 2017 by Christine Porter, University of Wyoming
Sponsor:
ClinicalTrials.gov Identifier:
NCT02672748
First Posted: February 3, 2016
Last Update Posted: May 4, 2017
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.
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)
Information provided by (Responsible Party):
Christine Porter, University of Wyoming
  Purpose
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.

Condition Intervention
Obesity Overweight Diabetes Other: Garden

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation

Resource links provided by NLM:


Further study details as provided by Christine Porter, University of Wyoming:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Mental Health change [ Time Frame: Change from baseline at 2 years ]
    measured by SF12 survey

  • Physical Health change [ Time Frame: Change from baseline at 2 years ]
    measured by SF12 survey

  • Food security change [ Time Frame: Change from baseline at 2 years ]
    measured by sub-set of USDA survey

  • Self-efficacy in gardening change [ Time Frame: Change from baseline at 2 years ]
    by survey

  • Pain change [ Time Frame: Change from baseline at 2 years ]
    by survey

  • Blood pressure change [ Time Frame: Change from baseline at 2 years ]
    researcher-measured with bp monitor

  • hand strength change [ Time Frame: Change from baseline at 2 years ]
    researcher-measured with dynamometer

  • waist circumference change [ Time Frame: Change from baseline at 2 years ]
    researcher-measured with spring-loaded tape measure

  • beta-carotene change [ Time Frame: Change from baseline at 2 years ]
    whole blood draw and assay

  • Hb A1C change [ Time Frame: Change from baseline at 2 years ]
    whole blood draw and assay

  • cholesterol change [ Time Frame: Change from baseline at 2 years ]
    whole blood draw and assay

  • triglycerides change [ Time Frame: Change from baseline at 2 years ]
    whole blood draw and assay

  • vitamin D change [ Time Frame: Change from baseline at 2 years ]
    whole blood draw and assay

  • child BMI z-score change [ Time Frame: Change from baseline at 2 years ]

Estimated Enrollment: 400
Study Start Date: November 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gardening
Receiving two years of technical, labor and financial support in starting, growing, and harvesting from a home food garden.
Other: 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.

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

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:   5 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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): NCT02672748


Contacts
Contact: Christine M Porter, PhD 3077662143 christine.porter@uwyo.edu
Contact: Alyssa Wechsler, MS 307 399 3247 alywex@uwyo.edu

Locations
United States, Wyoming
University of Wyoming Recruiting
Laramie, Wyoming, United States, 82071
Contact: Christine M Porter, PhD    307-766-2143    christine.porter@uwyo.edu   
Sponsors and Collaborators
University of Wyoming
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)
Investigators
Principal Investigator: Christine M Porter, PhD University of Wyoming
  More Information

Additional Information:
Responsible Party: Christine Porter, Associate Professor, University of Wyoming
ClinicalTrials.gov Identifier: NCT02672748     History of Changes
Other Study ID Numbers: R01HL126666-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2015
First Posted: February 3, 2016
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).

Keywords provided by Christine Porter, University of Wyoming:
garden
Native American
BMI
Emotional health
Physical health

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms