Food Resource Equity and Sustainability for Health

Blood Pressure Clinical Trial

— FRESH  

Official title:

Food Resource Equity and Sustainability for Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251950
• Other study ID #: R01MD011266
• Secondary ID: R01MD011266
• Status: Completed
• Phase: N/A
• Start date: August 22, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2019
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• American Indian Children aged 3-5 who attend one of the Osage Nation Early Childhood Programs

• Parents of American Indian children who are aged 18 years and older and whose children are enrolled in Osage Nation Early Childhood Programs

Exclusion Criteria:

• Anyone not meeting the aforementioned inclusion criteria

Related Conditions & MeSH terms

• Blood Pressure
• BMI

Intervention

Behavioral:
• healthy eating and gardening
15 week healthy eating and gardening intervention for children aged 3-5 years; 15 week online parenting intervention to promote healthy eating; Menu change in early childhood center to promote healthy eating

Locations

Country	Name	City	State
United States	Oklahoma State Univeristy Center for Health Sciences	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vegetable and fruit intake among children aged 3-5	Targeted quarter cup increase in vegetable and fruit intake per day	Measured before and after the 15 week intervention