Blood Pressure, Diet, Healthy, Food Insecurity, Health Status, Overweight or Obesity
Conditions
Keywords
Blood Pressure, Obesity, CBPR, American Indian, BMI, Food Environment, Blood Lipids
Brief 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 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: 1. 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; 2. 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 3. 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
Interventions
BEHAVIORAL"Go Healthy" program
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
Sponsors
Oklahoma State University Center for Health Sciences
University of Oklahoma
Osage Nation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Adult Participant Inclusion Criteria: * 18-75 years of age * Identify as Native American (index adult participant only) * Reside in Osage Nation * Plan to stay in Osage Nation in the next year * Overweight ot obesity, defined as BMI \>= 25 kg/m2, measured by research staff (index adult participant only) * Willing and able to follow study procedures Child Participant Inclusion Criteria: * 3-17 years of age * Reside in Osage Nation * Plan to stay in Osage Nation in the next year * Willing and able to follow study procedures
Exclusion criteria
* Those that are pregnant or planning to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diet From Baseline | 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 | 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 | 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 | Baseline and 16-week follow-up | Measured on adults only. Used a non-fasting blood sample device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI From Baseline | Baseline and 16-week follow-up | BMI (kg/m2) was calculated using measuredvheight and weight |
| Change in HbA1c From Baseline | Baseline and 16-week follow-up | Measured on adults only. Used a non-fasting blood sample device |
| Change in Food Insecurity From Baseline | Baseline and 16-week follow-up | 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. |
| Change in Skin Carotenoids From Baseline | Baseline and 16-week follow-up | Skin carotenoids were quantified using the Veggie Meter. Score range: 0 to 800. The higher the score, the higher vegetable intake. |
| Change in Health Status From Baseline to Follow-up | Baseline to 16-week 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORValarie Jernigan, DrPH
Oklahoma State University Center for Health Sciences
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 11-14 years | 12 Participants |
| Age, Customized 15-17 years | 0 Participants |
| Age, Customized 18-29 years | 47 Participants |
| Age, Customized 30-39 years | 43 Participants |
| Age, Customized 3-6 years | 20 Participants |
| Age, Customized 40-49 years | 46 Participants |
| Age, Customized 50-59 years | 33 Participants |
| Age, Customized 60+ years | 49 Participants |
| Age, Customized 7-10 years | 16 Participants |
| Age, Customized Unknown/Missing | 0 Participants |
| Alcohol use No | 0 Participants |
| Alcohol use Yes | 122 Participants |
| Anxiety No | 241 Participants |
| Anxiety Yes | 97 Participants |
| Cardiovascular disease No | 204 Participants |
| Cardiovascular disease Yes | 22 Participants |
| Depression No | 140 Participants |
| Depression Yes | 68 Participants |
| Diabetes No | 183 Participants |
| Diabetes Yes | 0 Participants |
| Education High school graduate, GED, or less | 144 Participants |
| Education Some post-secondary | 123 Participants |
| Education Unknown/Missing | 8 Participants |
| Education -year, 4-year degree, or postgraduate | 156 Participants |
| Employment status Employed | 274 Participants |
| Employment status Retired, unable to work, or other | 123 Participants |
| Employment status Unemployed | 23 Participants |
| Employment status Unknown/Missing | 11 Participants |
| Food security High food security | 70 Participants |
| Food security Low food security | 0 Participants |
| Food security Marginal food security | 98 Participants |
| Food security Unknown/Missing | 4 Participants |
| Food security Very low food security | 0 Participants |
| Health status Excellent | 0 Participants |
| Health status Fair | 0 Participants |
| Health status Good | 178 Participants |
| Health status Poor | 28 Participants |
| Health status Unknown/Missing | 0 Participants |
| Health status Very good | 70 Participants |
| Household income $100,000 or more | 0 Participants |
| Household income $40,000 to $99,999 | 75 Participants |
| Household income Less than $39,999 | 109 Participants |
| Household income Unknown/Missing | 15 Participants |
| Hypertension No | 207 Participants |
| Hypertension Yes | 0 Participants |
| Marital status Divorced, separated, or widowed | 0 Participants |
| Marital status Married | 190 Participants |
| Marital status Not married | 59 Participants |
| Marital status Unknown/Missing | 0 Participants |
| Physical activity Bicycling | 0 Participants |
| Physical activity None | 20 Participants |
| Physical activity Other aerobic exercise | 40 Participants |
| Physical activity Stretching | 0 Participants |
| Physical activity Swimming | 0 Participants |
| Physical activity Unknown/Missing | 0 Participants |
| Physical activity Walk for exercise | 0 Participants |
| Prediabetes No | 140 Participants |
| Prediabetes Yes | 0 Participants |
| Race/Ethnicity, Customized Native American | 150 Participants |
| Race/Ethnicity, Customized Native American + another race | 27 Participants |
| Race/Ethnicity, Customized Non-Native American | 42 Participants |
| Race/Ethnicity, Customized Unknown/Missing | 0 Participants |
| Sex/Gender, Customized Female | 343 Participants |
| Sex/Gender, Customized Male | 31 Participants |
| Sex/Gender, Customized Other | 0 Participants |
| Sex/Gender, Customized Unknown/Missing | 0 Participants |
| Smoking No | 168 Participants |
| Smoking Yes | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 2 / 218 | 0 / 64 | 0 / 67 |
| other Total, other adverse events | 0 / 213 | 0 / 218 | 0 / 64 | 0 / 67 |
| serious Total, serious adverse events | 0 / 213 | 0 / 218 | 0 / 64 | 0 / 67 |
Outcome results
None listed