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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
| Osage Nation | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Households 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Go Healthy" program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline and 16-week follow-up |
| Change in LDL-C From Baseline | Measured on adults only. Used a non-fasting blood sample device | Baseline and 16-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI From Baseline | BMI (kg/m2) was calculated using measuredvheight and weight | Baseline and 16-week follow-up |
| Change in HbA1c From Baseline | Measured on adults only. Used a non-fasting blood sample device |
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Adult Participant Inclusion Criteria:
Child Participant Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valarie Jernigan, DrPH | Oklahoma State University Center for Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Osage Nation | Pawhuska | Oklahoma | 74056 | United States |
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445 adults and 135 children consented and were enrolled into the study (total participants; n=580). After individual-level enrollment and consent, we administered baseline data collection to all participants. Randomization occurred on the household-level and did not occur until after baseline data collection was complete and we were able to tally household numbers for randomization. Among the 580 that signed consent forms, we could not contact 18 participants to complete baseline demographics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Households that received the "Go Healthy" program |
| FG001 | Control | Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Households were randomized after baseline data completion. After enrollment, 14 adults (12 households) and 4 children either withdrew or were lost to follow-up before we could get their baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - Adult | Individuals that received the "Go Healthy" program |
| BG001 | Control - Adult | Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 31 participants were lost to follow-up from baseline | Posted | Mean | Standard Error | Score | Baseline to 16-week follow-up |
|
From enrollment until end of follow-up, up to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group - Adults | Individuals that received the "Go Healthy" program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaylee Clyma | Oklahoma State University Center for Health Sciences | 918-561-1581 | kaylee.clyma@okstate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 30, 2024 | Dec 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2025 | Dec 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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. | 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. | 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. | Baseline to 16-week follow-up |
| Moved out of Osage Nation |
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| Lost to Follow-up |
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| BG002 | Intervention - Children | Children of individuals that received the "Go Healthy" program |
| BG003 | Control - Children | Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex/Gender, Customized | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Two adults in the intervention group and two adults in the wait-list control group has Missing race/ethnicity and were not included in the table. | Count of Participants | Participants |
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| Education | Highest level of education | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Marital status | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Household income | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Employment status | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
|
| Food security | USDA 18-item food security scale. Responses of "yes," "often," "sometimes," "almost every month," and "some months but not every month" are coded as affirmative. The sum of affirmative responses to a specified set of items is referred to as the household's raw score on the scale comprising those items. Raw score zero-High food security; Score 1-2-Marginal food security; Score 3-7-Low food security; Score 8-18-Very low food security. | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
|
| Smoking | Current smoking status | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
|
| Alcohol use | Current alcohol use | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Diabetes | Self-reported | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Prediabetes | Self-reported pre-diabetes (told by a doctor) | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Depression | Self-reported | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Anxiety | Self-reported | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Hypertension | Self-reported (told from a doctor) | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Cardiovascular disease | Self-reported (told from a doctor) | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
|
| Health status | General health question from the SF-36 and the EQ-5D-5L questionnaire | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
|
| Physical activity | Analyzed for adults only. Baseline data not collected from Children Participants. | Count of Participants | Participants |
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| Primary | 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. | 31 participants were lost to follow-up from baseline | Posted | Mean | Standard Error | mmHg | Baseline and 16-week follow-up |
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|
| Primary | 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. | 31 participants were lost to follow-up from baseline | Posted | Mean | Standard Error | mmHg | Baseline and 16-week follow-up |
|
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| Primary | Change in LDL-C From Baseline | Measured on adults only. Used a non-fasting blood sample device | 31 participants were lost to follow-up from baseline | Posted | Mean | Standard Error | mg/dL | Baseline and 16-week follow-up |
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| Secondary | Change in BMI From Baseline | BMI (kg/m2) was calculated using measuredvheight and weight | 31 adults and 37 children were lost to follow-up after the baseline visit | Posted | Mean | Standard Error | kg/m^2 | Baseline and 16-week follow-up |
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| Secondary | Change in HbA1c From Baseline | Measured on adults only. Used a non-fasting blood sample device | 31 participants were lost to follow-up from baseline | Posted | Mean | Standard Error | Percent | Baseline and 16-week follow-up |
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| Secondary | 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. | 31 participants were lost to follow-up from baseline | Posted | Mean | Standard Error | Score on a scale | Baseline and 16-week follow-up |
|
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| Secondary | 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. | 31 adults and 37 children were lost to follow-up. | Posted | Mean | Standard Error | Score on a scale | Baseline and 16-week follow-up |
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| Secondary | 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. | 4 intervention participants and 1 control participant were missing data. | Posted | Number | Proportion | Baseline to 16-week follow-up |
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| 0 |
| 213 |
| 0 |
| 213 |
| 0 |
| 213 |
| EG001 | Wait-list Control Group - Adults | Individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over | 2 | 218 | 0 | 218 | 0 | 218 |
| EG002 | Intervention Group - Children | Children of individuals that received the "Go Healthy" program | 0 | 64 | 0 | 64 | 0 | 64 |
| EG003 | Wait-list Control Group - Children | Children of individuals that received compensation equal in value to the "Go Healthy" program after the intervention period was over | 0 | 67 | 0 | 67 | 0 | 67 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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