Healthy Living Anson
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Med-South Dietary Risk Assessment Score
研究概览
简要总结
The goal of this randomized delayed control intervention research study is to see if participants who receive education and healthy prepared meals improve the quality of their diet compared to participants who receive only physical activity education and coaching.
详细描述
Purpose: Evaluate whether a Food is Medicine (FIM) intervention improves the quality of food intake among rural adults who have at least one chronic disease or are at risk for chronic disease compared to those receiving a physical activity intervention.
Participants: English speaking Anson County residents 18 years or older
Procedures: Randomized delayed intervention control study design - 4 months receive either the FIM intervention (healthy frozen meals and/or produce box, and education by a Community Health Advocate (CHA) or physical activity (PA) education and support via a CHA. At the end of the 4 months, the FIM group will receive the PA intervention, and the PA group receives the FIM intervention with both groups continuing for another 4 months. Data collected will include a funder required survey (demographics, social, and behavioral factors) plus additional study related questions and biometrics. The survey will be completed online or in person for those requiring internet access or support. The biometrics will be obtained at an in-person session. Once enrollment is complete, participants will be randomized into either the FIM or PA group and receive their study materials. Data collection will occur at baseline, midpoint, and at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential participants must be a resident of Anson County.
- •At least 18 years of age.
- •Have or be at risk for a chronic disease.
- •Ability to make own dietary decisions.
- •Ability to travel to a central Anson County location for data collection and group class sessions.
- •Ability and willingness to try the prepared meals.
- •Ability to store 10 frozen meals in a freezer.
- •Ability to communicate in English
- •No dietary restrictions or food allergies such that a Mediterranean diet is not appropriate.
排除标准
- 未提供
结局指标
主要结局
Med-South Dietary Risk Assessment Score
时间窗: Baseline, Midpoint (Month 4), Endpoint (up to Month 10)
The Med-South Dietary Risk Assessment (DRA) is scored as the sum of the column score for each numbered item, with column score multiplied by 0.5 for Items 3.3 and 3.4. The score ranges from 0 to 10, 0 meaning no adherence and 10 meaning full adherence. With regard to diet quality, the first response option is considered "desirable," the second "could be improved," and the third "needs to be improved.
次要结局
- Physical Activity Questionnaire(Baseline, Midpoint (Month 4), Endpoint (Up to Month 10))
- Skin Carotenoids(Baseline, Midpoint (month 4), Endpoint (up to month 10))
- Nutrition Insecurity(baseline, endpoint)