ObesityGRNCT02672748
Growing Resilience in Wind River Indian Reservation
A study testing Garden in people with Obesity and Overweight, run by University of Wyoming at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Diabetes
- What is being tested?
- Garden
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- had a home food garden plot in the previous year that is over 30 square feet in area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation
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.
Read the 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.
- Conditions
- Obesity, Overweight, Diabetes
- Being tested
- Garden
- Keywords
- garden, Native American, BMI, Emotional health, Physical health
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardenOther
Two years of financial and technical home gardening support for new gardeners
| Study group | Role | What they receive |
|---|---|---|
| Gardening | Experimental | Receiving two years of technical, labor and financial support in starting, growing, and harvesting from a home food garden. Receives: Other: Garden |
| Control | No intervention | The control families receive a garden as a delayed intervention after two years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult BMI change
With four data points, every 6 months. Researcher-measured height (stadiometer) and Tanita body composition scale.
Measured: Change from baseline at 2 years
Secondary outcomes (14)
Mental Health change
measured by SF12 survey
Measured: Change from baseline at 2 years
Physical Health change
measured by SF12 survey
Measured: Change from baseline at 2 years
Food security change
measured by sub-set of USDA survey
Measured: Change from baseline at 2 years
Self-efficacy in gardening change
by survey
Measured: Change from baseline at 2 years
Pain change
by survey
Measured: Change from baseline at 2 years
Blood pressure change
researcher-measured with bp monitor
Measured: Change from baseline at 2 years
hand strength change
researcher-measured with dynamometer
Measured: Change from baseline at 2 years
waist circumference change
researcher-measured with spring-loaded tape measure
Measured: Change from baseline at 2 years
beta-carotene change
whole blood draw and assay
Measured: Change from baseline at 2 years
Hb A1C change
whole blood draw and assay
Measured: Change from baseline at 2 years
cholesterol change
whole blood draw and assay
Measured: Change from baseline at 2 years
triglycerides change
whole blood draw and assay
Measured: Change from baseline at 2 years
vitamin D change
whole blood draw and assay
Measured: Change from baseline at 2 years
child BMI z-score change
Measured: Change from baseline at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2021
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Principal investigator, Christine Porter, University of Wyoming
- Investigators
- Christine M Porter, PhD, Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672748
- Sponsor's protocol ID
- R01HL126666-01A1
- Other IDs
- R01HL126666-01A1
- Acronym
- GR
- Status last verified
- Jul 2023
- First submitted
- 9 Nov 2015
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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).
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.
PubMed 35898313Porter 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.
PubMed 31441769Porter 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.
PubMed 30948560
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Resilience: an RCT on the Health Impact of Gardens With Wind River Indian Reservation
- ClinicalTrials.gov ID
- NCT02672748
- Acronym / sponsor ID
- GR / R01HL126666-01A1
- Conditions
- Obesity, Overweight, Diabetes
- Keywords
- garden, Native American, BMI, Emotional health, Physical health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- 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)
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gardening | Experimental | Other: GardenReceiving two years of technical, labor and financial support in starting, growing, and harvesting from a home food garden. |
| Control | No intervention | –The control families receive a garden as a delayed intervention after two years. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- had a home food garden plot in the previous year that is over 30 square feet in area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GardenTwo years of financial and technical home gardening support for new gardeners | Other | Gardening |
Primary outcome
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.
14 secondary outcomes
Mental Health change
Time frame: Change from baseline at 2 years
Physical Health change
Time frame: Change from baseline at 2 years
Food security change
Time frame: Change from baseline at 2 years
Self-efficacy in gardening change
Time frame: Change from baseline at 2 years
Pain change
Time frame: Change from baseline at 2 years
Blood pressure change
Time frame: Change from baseline at 2 years
hand strength change
Time frame: Change from baseline at 2 years
waist circumference change
Time frame: Change from baseline at 2 years
beta-carotene change
Time frame: Change from baseline at 2 years
Hb A1C change
Time frame: Change from baseline at 2 years
cholesterol change
Time frame: Change from baseline at 2 years
triglycerides change
Time frame: Change from baseline at 2 years
vitamin D change
Time frame: Change from baseline at 2 years
child BMI z-score change
Time frame: Change from baseline at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 35898313Naschold 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.
- Derived from this study: PubMed 31441769Porter 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.
- Derived from this study: PubMed 30948560Porter 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.
- website for the projectLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Porter, PhD principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garden in people with Obesity and Overweight, run by University of Wyoming at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult BMI change (time frame: Change from baseline at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672748, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.