Osage Community Supported Agriculture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Change in Diet From Baseline
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Those that are pregnant or planning to become pregnant during the study period
研究组 & 干预措施
Intervention Group
Households that received the "Go Healthy" program
干预措施: "Go Healthy" program (Behavioral)
Wait-list Control Group
Households that received compensation equal in value to the "Go Healthy" program after the intervention period was over
结局指标
主要结局
Change in Diet From Baseline
时间窗: 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 LDL-C From Baseline
时间窗: Baseline and 16-week follow-up
Measured on adults only. Used a non-fasting blood sample device
Change in Systolic Blood Pressure From Baseline
时间窗: 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
时间窗: 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.
次要结局
- Change in BMI From Baseline(Baseline and 16-week follow-up)
- Change in HbA1c From Baseline(Baseline and 16-week follow-up)
- Change in Food Insecurity From Baseline(Baseline and 16-week follow-up)
- Change in Skin Carotenoids From Baseline(Baseline and 16-week follow-up)
- Change in Health Status From Baseline to Follow-up(Baseline to 16-week follow-up)