BMIFRESHNCT03251950
Food Resource Equity and Sustainability for Health
A study testing healthy eating and gardening in people with BMI and Blood Pressure, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- BMI, Blood Pressure
- What is being tested?
- healthy eating and gardening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anyone not meeting the aforementioned inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State Univeristy Center for Health Sciences
Tulsa, Oklahoma, 74106
About this study
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.
Read the 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.
- Conditions
- BMI, Blood Pressure
- Being tested
- healthy eating and gardening
- Keywords
- Vegetable and fruit intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy eating and gardeningBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: healthy eating and gardening |
| Control group | Other | Wait list control -- to receive intervention after serving as wait list group Receives: Behavioral: healthy eating and gardening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vegetable and fruit intake among children aged 3-5
Targeted quarter cup increase in vegetable and fruit intake per day
Measured: Measured before and after the 15 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start22 Aug 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Valarie BB Jernigan, DrPH, Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251950
- Sponsor's protocol ID
- R01MD011266
- Other IDs
- R01MD011266
- Acronym
- FRESH
- Status last verified
- Mar 2019
- First submitted
- 14 Aug 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37181935Sleet 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.
PubMed 32258996Sisson 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.
PubMed 32258995
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Resource Equity and Sustainability for Health
- ClinicalTrials.gov ID
- NCT03251950
- Acronym / sponsor ID
- FRESH / R01MD011266
- Conditions
- BMI, Blood Pressure
- Keywords
- Vegetable and fruit intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: healthy eating and gardening15 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 |
| Control group | Other | Behavioral: healthy eating and gardeningWait list control -- to receive intervention after serving as wait list group |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Anyone not meeting the aforementioned inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthy eating and gardening15 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 | Behavioural | Control group, Intervention group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Derived from this study: PubMed 37181935Patel 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.
- Derived from this study: PubMed 32258996Sleet 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.
- Derived from this study: PubMed 32258995Sisson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valarie BB Jernigan, DrPH principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healthy eating and gardening in people with BMI and Blood Pressure, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vegetable and fruit intake among children aged 3-5 (time frame: Measured before and after the 15 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251950, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.