Food as Medicine: A Quasi-Randomized Control Trial of Healthy Foods for Chronic Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in participants' body weight
研究概览
简要总结
The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level.
The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.
详细描述
Participants will receive healthy food items for 15 weeks and nutrition counseling and education to support chronic disease management at no cost. The healthy food items will consist of either medically-tailored pre-prepared meals, or a weekly produce box with recipes depending on the study arm. Participants must complete a baseline study visit, one nutritional counseling session via phone, 2 to 4 nutrition education videos, and a 16-week post-intervention study visit.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older who are patients at Akron General Center for Family Medicine
- •Have body mass index (BMI) equal to or greater that 30kg/m2 AND
- •Have at least one of the following diagnoses determined based on patients' problem list in the electronic medical record (EMR) and the international classification of diseases, 10th revision (ICD-10) codes:
- •Pre-type 2 diabetes mellitus
- •Type 2 diabetes mellitus
- •Hypertension
- •Have NOT participated in nutrition counseling at the University of Akron Nutrition Center within the past 6 months
排除标准
- •Food allergies
- •No access to internet
- •Need English language interpretation
- •Currently participating in a structured weight loss program or using weight loss medications
- •Any condition that, in the Investigator's judgement, interferes with the ability to adhere to study requirements.
结局指标
主要结局
Change in participants' body weight
时间窗: From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline
Percent weight loss
次要结局
- Type 2 diabetes mellitus: Change in number of medications(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Pre-type 2 diabetes mellitus: Change in number of medications(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Pre-type 2 diabetes mellitus: Change in medication dosage(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Pre-type 2 diabetes mellitus: Change in HbA1c(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Type 2 diabetes mellitus: Change in medication dosage(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Receipt of healthy food items: The Hunger Vital Sign scale(Baseline visit (W1) to week 16 visit)
- Receipt of healthy food items: Eating at America's Table scale(Baseline visit (W1) to week 16 visit)
- Type 2 diabetes mellitus: Change in HbA1c(From baseline visit (W1) to 16 week visit and at 6 months and 12 months from baseline)
- Hypertension: Change in number of medications(Baseline visit (W1) to 16 week visit)
- Hypertension: Change in medication dosage(Baseline visit (W1) to 16 week visit)
- Receipt of healthy food items: Patient Health Questionnaire-8 Depression Scale(Baseline visit (W1) to week 16 visit)
- Nutrition Education: Healthy Eating and Weight Self-Efficacy Scale(Baseline visit (W1) to 16-week visit)
- Nutrition Education: Self-Efficacy for Managing Chronic Diseases Scale(Baseline visit (W1) to 16-week visit)