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OpenTrials
Completed

NCT Number: NCT03251950

Food Resource Equity and Sustainability for Health

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.

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Key information

Conditions

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State Univeristy Center for Health Sciences

Tulsa, Oklahoma, 74106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

healthy eating and gardening

Behavioral

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

Primary outcomes

  1. Vegetable and fruit intake among children aged 3-5

    Time frame: Measured before and after the 15 week intervention

    Targeted quarter cup increase in vegetable and fruit intake per day

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: FRESH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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