NCT03251950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
522

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 22, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

August 14, 2017

Last Update Submit

March 15, 2019

Conditions

Keywords

Vegetable and fruit intake

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

OTHER

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

Behavioral: healthy eating and gardening

Interventions

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 groupIntervention group

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State Univeristy Center for Health Sciences

Tulsa, Oklahoma, 74106, United States

Location

Related Publications (3)

  • Patel D, Sisson SB, Sleet K, Rickman R, Love C, Taniguchi T, Sisk M, Jernigan VBB. Changes in Meal and Menu Quality at Early Care and Education Programs after Training with Food Service Staff: the FRESH Study. Curr Dev Nutr. 2023 Feb 20;7(3):100040. doi: 10.1016/j.cdnut.2023.100040. eCollection 2023 Mar.

  • Sleet K, Sisson SB, Dev DA, Love C, Williams MB, Hoffman LA, Jernigan VBB. The Impact of Responsive Feeding Practice Training on Teacher Feeding Behaviors in Tribal Early Care and Education: The Food Resource Equity and Sustainability for Health (FRESH) Study. Curr Dev Nutr. 2019 Sep 20;4(Suppl 1):23-32. doi: 10.1093/cdn/nzz105. eCollection 2020 Jan.

  • Sisson SB, Sleet K, Rickman R, Love C, Bledsoe A, Williams M, Jernigan VBB. Impact of the 2017 Child and Adult Care Food Program Meal Pattern Requirement Change on Menu Quality in Tribal Early Care Environments: The Food Resource Equity and Sustainability for Health Study. Curr Dev Nutr. 2019 Aug 29;4(Suppl 1):12-22. doi: 10.1093/cdn/nzz094. eCollection 2020 Jan.

MeSH Terms

Interventions

Diet, HealthyGardening

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHorticultureAgricultureTechnology, Industry, and Agriculture

Study Officials

  • Valarie BB Jernigan, DrPH

    Oklahoma State University Center for Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

August 22, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations