Diet, HealthyISANCT05773833
Indigenous Supported Agriculture "Go Healthy"
A study testing "Go Healthy" program in people with Diet, Healthy and Blood Pressure, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking… Read more about this study
- Who is it for?
- Ages 3 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Blood Pressure, Overweight or Obesity
- What is being tested?
- "Go Healthy" program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Those that are pregnant or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osage Community Supported Agriculture
Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. The program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.
Read the detailed description
The study will implement a new community supported agriculture (CSA) program, which the investigators refer to as the "Go Healthy" Indigenous Supported Agriculture (ISA) program, in which citizens in Osage Nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. The investigators will test the efficacy of the "Go Healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among NA households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings.
Specific Aims:
- Conduct a randomized controlled trial to test the newly developed ISA program's effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin carotenoid measurement by Veggie Meter (secondary outcomes) among 200 NA households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as NA with overweight/obesity;
- Perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and
- Document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other NA communities to use to improve tribal food systems
- Being tested
- "Go Healthy" program
- Keywords
- Blood Pressure, Obesity, CBPR, American Indian, BMI, Food Environment, Blood Lipids
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Go Healthy" programBehavioural
Weekly food boxes of fresh fruits and vegetables for 16 weeks; healthy eating and traditional foods curriculum available inside the box; monthly in-person healthy eating and traditional Indigenous foods cooking workshop; Indigenous cooking demonstration video website links to accompany recipes; and a kitchen starter kit with kitchen cooking supplies
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Households that received the "Go Healthy" program Receives: Behavioral: "Go Healthy" program |
| Wait-list Control Group | No intervention | Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diet From Baseline
Measued on adults only. Change in vegetable and fruit intake using the National Cancer Instititute's Automated Self-Administered 24-hour Recall (ASA-24). This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI scores are reported.
Measured: Baseline to 16-week follow-up
Change in Systolic Blood Pressure From Baseline
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Measured: Baseline and 16-week follow-up
Change in Diastolic Blood Pressure From Baseline
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Measured: Baseline and 16-week follow-up
Change in LDL-C From Baseline
Measured on adults only. Used a non-fasting blood sample device
Measured: Baseline and 16-week follow-up
Secondary outcomes (5)
Change in BMI From Baseline
BMI (kg/m2) was calculated using measuredvheight and weight
Measured: Baseline and 16-week follow-up
Change in HbA1c From Baseline
Measured on adults only. Used a non-fasting blood sample device
Measured: Baseline and 16-week follow-up
Change in Food Insecurity From Baseline
Assessed on adults only. Scale: U.S. Household Food Security Survey Module. This instrument contains 18 items to capture the qualitative and quantitative dimensions of household food supply.
To compute levels of food security and insecurity, we will total the number of affirmative responses to these items, counting "Often" and "Sometimes" as affirmative.
Total score range: 0-18. The lower scores, the greater improvement in food security.
Measured: Baseline and 16-week follow-up
Change in Skin Carotenoids From Baseline
Skin carotenoids were quantified using the Veggie Meter. Score range: 0 to 800. The higher the score, the higher vegetable intake.
Measured: Baseline and 16-week follow-up
Change in Health Status From Baseline to Follow-up
Health status was measured using one question from the 36-Item Short Form Health Survey questionnaire "In general, how would you rate your health status?" With response options of Excellent, Very Good, Good, Fair, and Poor. This outcome assesses proportion difference between baseline and follow-up of excellent/very good.
Measured: Baseline to 16-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start22 Feb 2023
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diet, HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, Osage Nation
- Responsible party
- Sponsor
- Investigators
- Valarie Jernigan, DrPH, Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773833
- Sponsor's protocol ID
- 2021026
- Acronym
- ISA
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2023
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osage Community Supported Agriculture
- ClinicalTrials.gov ID
- NCT05773833
- Acronym / sponsor ID
- ISA / 2021026
- Keywords
- Blood Pressure, Obesity, CBPR, American Indian, BMI, Food Environment, Blood Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- University of Oklahoma, Osage Nation
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Native Americans (NAs) have limited access to healthy food and a high prevalence of diet-related diseases. This study will implement an agricultural and health education program in which NA residents of Osage Nation will receive a weekly share of healthy fresh produce coupled with healthy recipes and cooking materials. The program's effect on diet and health outcomes and it's cost-effectiveness will be evaluated, and study processes and findings will be broadly disseminated to support tribes in improving diet and health.
Detailed description
The study will implement a new community supported agriculture (CSA) program, which the investigators refer to as the "Go Healthy" Indigenous Supported Agriculture (ISA) program, in which citizens in Osage Nation will receive a weekly share of fresh fruits and vegetables for 16 weeks. The investigators will test the efficacy of the "Go Healthy" program combined with culturally-tailored nutrition and cooking education on diet and health outcomes among NA households, evaluate its cost-effectiveness, and develop a multimedia toolkit for disseminating findings.
Specific Aims:
- Conduct a randomized controlled trial to test the newly developed ISA program's effect on diet, blood pressure, and blood lipids (primary outcomes) and on body mass index (BMI), hemoglobin A1c (HbA1c), food insecurity, health status, and Skin carotenoid measurement by Veggie Meter (secondary outcomes) among 200 NA households (400 adults and up to 400 children) with an index household adult (aged 18-75) identifying as NA with overweight/obesity;
- Perform an economic evaluation for individual (e.g., health-related quality of life), organizational (e.g., healthcare utilization costs), and community-level (e.g., prevention of cardiometabolic diseases) outcomes; and
- Document and disseminate study processes and findings using participatory video methods, and compile a web-based toolkit for other NA communities to use to improve tribal food systems
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: "Go Healthy" programHouseholds that received the "Go Healthy" program |
| Wait-list Control Group | No intervention | –Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Those that are pregnant or planning to become pregnant during the study period
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 |
|---|---|---|
| "Go Healthy" programWeekly food boxes of fresh fruits and vegetables for 16 weeks; healthy eating and traditional foods curriculum available inside the box; monthly in-person healthy eating and traditional Indigenous foods cooking workshop; Indigenous cooking demonstration video website links to accompany recipes; and a kitchen starter kit with kitchen cooking supplies | Behavioural | Intervention Group |
Primary outcome
Change in Diet From Baseline
Time frame: Baseline to 16-week follow-up
Measued on adults only. Change in vegetable and fruit intake using the National Cancer Instititute's Automated Self-Administered 24-hour Recall (ASA-24). This self-report instrument generates a "healthy eating index" (HEI), with scores ranging from 0 (least healthy) to 100 (healthiest). Continuous values of the overall HEI scores are reported.
Change in Systolic Blood Pressure From Baseline
Time frame: Baseline and 16-week follow-up
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Change in Diastolic Blood Pressure From Baseline
Time frame: Baseline and 16-week follow-up
Measured on adults only. Microlife BPM2 Advanced Blood Pressure Monitor. Three total measurements were taken, and we averaged the last two for our results.
Change in LDL-C From Baseline
Time frame: Baseline and 16-week follow-up
Measured on adults only. Used a non-fasting blood sample device
5 secondary outcomes
Change in BMI From Baseline
Time frame: Baseline and 16-week follow-up
Change in HbA1c From Baseline
Time frame: Baseline and 16-week follow-up
Change in Food Insecurity From Baseline
Time frame: Baseline and 16-week follow-up
Change in Skin Carotenoids From Baseline
Time frame: Baseline and 16-week follow-up
Change in Health Status From Baseline to Follow-up
Time frame: Baseline to 16-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 "Go Healthy" program in people with Diet, Healthy 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 0 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 18 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Diet From Baseline (time frame: Baseline to 16-week follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.