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Trial record 32 of 42 for:    "native american" OR "american indian" | Recruiting, Not yet recruiting, Available Studies

Food Resource Equity and Sustainability for Health (FRESH)

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ClinicalTrials.gov Identifier: NCT03251950
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
BMI Blood Pressure Behavioral: healthy eating and gardening Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Food Resource Equity and Sustainability for Health
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Intervention group
15 week healthy eating and gardening curriculum to be implemented in Osage Nation Early Childhood Programs; 15 week healthy eating parenting curriculum to be implemented online to parents of enrolled children
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

Control group
Wait list control -- to receive intervention after serving as wait list group
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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03251950


Contacts
Contact: Leslie Carroll 9186603684 leslie-carroll@ouhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Tulsa, Oklahoma, United States, 74105
Contact: Valarie Jernigan, DrPH, MPH    918-660-3678    Valarie-Jernigan@ouhsc.edu   
Contact: Charlie Love, MPH    9186603678    Charlotte-V-Love@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Valarie Jernigan, DrPH University of Oklahoma Health Sciences Center - Tulsa

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03251950     History of Changes
Other Study ID Numbers: R01MD011266 ( U.S. NIH Grant/Contract )
R01MD011266 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oklahoma:
Vegetable and fruit intake