Food Is Medicine Shared Medical Appointments for Weight Management: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention Method (AIM)
研究概览
简要总结
The goal of this study is to determine whether shared medical visits also called "group visits" would be beneficial for patients who are under weight management care.
As part of this study, participants will be asked to complete a survey to give the study team a better idea of their current health conditions and if this study will be good fit for them. Once the survey has been completed, participants will then be randomly assigned to one of two groups. Group one will include participation in shared medical visits over a period of eight weeks. In addition to the medical visits, this group will also include two cooking classes. Group two will be asked to complete online Full Living Plate modules. Participants will be asked to complete another survey at the end of the study.
详细描述
The purpose of this study is to have participants who are undergoing weight management attend new types of medical visits called "shared medical visits" and provide their feedback to the research staff. The shared medical visit or group visit is a new method of care delivery at Duke University Health System where patients with similar medical conditions have an appointment as a group with a provider. Patients can decide to share with the group or share privately with the provider team. Up to 50 people will take part in this study at Duke.
As part of this study, participants will be asked to complete a survey prior to starting the study to make sure that they are a good fit for the study.
Participants will be randomly assigned (like the flip of a coin) to one of two groups. Those placed in group one will have 4 group visit sessions that include 2 cooking demonstrations and those placed in group two will be asked to complete online Full Plate Living Modules. Both groups will receive the medically tailored groceries and can complete both the pre-survey and post-survey. Both groups will receive similar content, although only the individuals in the first option will have the opportunity to attend in-person group visit sessions. In-person sessions will be held at the Duke Integrative Medicine Center.
While on study, participants will receive medically tailored groceries delivered to their home every other week. Each delivery is about 70 servings of produce with possible additional grocery items.
If participants are unable to attend one of the group sessions while they are in the study, Telehealth group visits will be offered. However, this is not an alternative to an in-person class. This is being offered and approved by the study doctor on a case-by-case basis.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients actively receiving care at the Duke Lifestyle and Weight Management Center (DLWMC)
- •Patients with obesity defined by BMI ≥30 kg/m2
- •Patients must live in Durham County
- •Patients age ≥18 years
- •Patients must be willing and able to consent to participating in 4 shared medical appointments with 10-13 other DLWMC patients over the course of 8 weeks
- •DLWMC provider must medically clear their participation in this program
排除标准
- •Patients with unstable medical or mental health condition, as deemed by their DLWMC medical provider (e.g., uncontrolled eating disorder, active severe major depression, gastrointestinal disease that would preclude consumption of a high fiber diet)
- •Patients who are pregnant or plan to become pregnant will be excluded, as change in weight will be a secondary outcome and patients may have specific dietary needs not covered by the content offered by this study
研究组 & 干预措施
Control
Completion of online Full Living Plate modules over eight weeks
干预措施: Full Plate Living (Behavioral)
Intervention
Attend shared medical visits over eight weeks and attend two cooking classes.
干预措施: Shared Medical Visits (Behavioral)
结局指标
主要结局
Acceptability of Intervention Method (AIM)
时间窗: 0 and 12 weeks
"Acceptability" is defined as the perception among participants that a given treatment (food is medicine intervention with either group visits or online modules) is agreeable, palatable, or satisfactory. The AIM total score ranges from 1 to 20, where a higher score indicates greater acceptability.
Intervention Appropriateness Measure (IAM)
时间窗: 0 and 12 weeks
"Appropriateness" is defined as the perceived fit, relevance, or compatibility of the treatment (food is medicine intervention with either group visits or online modules) for the practice setting, provider, and participant; and/or perceived fit of the innovation to address obesity. The IAM total score ranges from 1 to 20, where a higher score indicates greater appropriateness.
次要结局
- Fruit and Vegetable Consumption as measured by the 10-item Dietary Screener Questionnaire (DSQ)(0 and 12 weeks)
- Number of participants with Nutrition Security(0 and 12 weeks)