Effect of Functional Medicine Health Coaching on Self-Reported Measures of Physical and Emotional Health: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline PROMIS-Global Health score
研究概览
简要总结
The goal of this research is to evaluate the feasibility and self-reported health outcomes of functional medicine health coaching in elimination diets among clinicians receiving training in functional medicine.
A randomized controlled clinical trial of a 5-session functional medicine coaching and elimination diet intervention will be conducted to achieve the purpose of this study. The research team hypothesizes that functional medicine health coaching to support the elimination diet will improve physical and mental health outcomes better than the control condition of a self-guided elimination diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agree to adopt the elimination diet as outlined by study sponsor with no pre-planned interruption
- •Able to understand and write English
- •Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
排除标准
- •Eating disorders within the past 10 years
- •Currently pregnant or breastfeeding
- •Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants
结局指标
主要结局
Change from baseline PROMIS-Global Health score
时间窗: Change from baseline at 10 weeks
The PROMIS Global Health is a 10-item survey (PROMIS-10) is measure of health status that spans physical, mental, and social domains from the patient perspective, allowing clinicians and researchers to capture the complex and heterogeneous nature of the populations.
次要结局
- Change from baseline Medical Symptoms Questionnaire (MSQ) score(Change from baseline at 10 weeks)
- Adherence/compliance to the elimination diet(At 10 weeks)