Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-01 @ 9:54 PM
Study NCT ID:
NCT03251950
Status:
COMPLETED
Last Update Posted:
2019-03-19
First Post:
2017-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Resource Equity and Sustainability for Health
Sponsor:
Oklahoma State University Center for Health Sciences
Organization:
Study Overview
Official Title:
Food Resource Equity and Sustainability for Health
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRESH
Brief Summary:
Food insecurity increases the risk of obesity, diabetes, hypertension, and cancer. American Indians (AIs) in Oklahoma are three times as likely as Whites to be food-insecure (21% vs. 7%) and have burdens of obesity (42%), hypertension (38%), and diabetes (15%) that exceed those of the general US population. While individual-level obesity prevention efforts have been implemented with AIs, few environmental interventions to reduce food insecurity and improve fruit and vegetable intake have been conducted with tribal communities. Community gardening interventions have been shown to increase vegetable and fruit intake, reduce food insecurity, and lower BMI among children and adults; however, to date, no such interventions have been evaluated with AI families. The proposed study, entitled "Food Equity Resource and Sustainability for Health (FRESH)," will assess the impact of a tribally-initiated community gardening intervention on vegetable and fruit intake, food insecurity, BMI, and blood pressure in families living on the Osage Nation reservation in Oklahoma.
Detailed Description:
The intervention will take place in the inaugural year of Osage Nation's Bird Creek Farm and Community Gardens, where 120 garden plots will be allocated to participating reservation families. The study is guided by the principles of community-based participatory research (CBPR) and the Indigenous food sovereignty movement, which seeks to revitalize seasonal growing and gathering practices and reverse the tide of unhealthy eating caused by the historical loss of tribal lands.
Aims and Methods: Led by an AI (Choctaw) Investigator, the study will:
Aim #1: Characterize the Osage Nation reservation's food environment by using both objective and perceived measures, and then examine the relationships between these measures and intake of vegetables and fruits, food insecurity, BMI, hypertension, and diabetes.
Aim #2: Develop a culturally relevant community gardening intervention and conduct a randomized controlled trial (RCT) to evaluate its efficacy in increasing vegetable and fruit intake and reducing food insecurity, BMI, and blood pressure among Osage families.
Aim #3: Create and disseminate a Web- based multimedia manual and documentary film, and evaluate their effectiveness in increasing tribal readiness and capacity to improve local food environments.
Innovation: The proposed study will be the first RCT ever conducted of a community gardening intervention, as well as the first community gardening intervention with AI families. The study will also be one of the first environmental interventions o simultaneously address healthy food production, access, preference, and intake among AIs.
Significance and Impact: The community gardening intervention will be developed as part of a larger Osage Nation initiative on food security and food sovereignty and as such, is likely to be sustainable if it proves effective. Research findings and products will be disseminated to AI/AN communities nationwide and will help to identify environmental strategies that will improve tribal food environments and the health and quality of life of AI families.
Aims and Methods: Led by an AI (Choctaw) Investigator, the study will:
Aim #1: Characterize the Osage Nation reservation's food environment by using both objective and perceived measures, and then examine the relationships between these measures and intake of vegetables and fruits, food insecurity, BMI, hypertension, and diabetes.
Aim #2: Develop a culturally relevant community gardening intervention and conduct a randomized controlled trial (RCT) to evaluate its efficacy in increasing vegetable and fruit intake and reducing food insecurity, BMI, and blood pressure among Osage families.
Aim #3: Create and disseminate a Web- based multimedia manual and documentary film, and evaluate their effectiveness in increasing tribal readiness and capacity to improve local food environments.
Innovation: The proposed study will be the first RCT ever conducted of a community gardening intervention, as well as the first community gardening intervention with AI families. The study will also be one of the first environmental interventions o simultaneously address healthy food production, access, preference, and intake among AIs.
Significance and Impact: The community gardening intervention will be developed as part of a larger Osage Nation initiative on food security and food sovereignty and as such, is likely to be sustainable if it proves effective. Research findings and products will be disseminated to AI/AN communities nationwide and will help to identify environmental strategies that will improve tribal food environments and the health and quality of life of AI families.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MD011266 | NIH | None | https://reporter.nih.gov/quic… | View |