Effect of Functional Medicine Health Coaching on Self-Reported Measures of Physical and Emotional Health: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline PROMIS-Global Health score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Eating disorders within the past 10 years
- •Currently pregnant or breastfeeding
- •Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants
Arms & Interventions
Functional Medicine Health Coaching for Elimination Diet
Participants randomized into the "Functional Medicine Health Coaching for Elimination Diet" arm will receive five remote health coaching sessions over 10 weeks in support of their progress through an elimination diet. All study arms will receive written elimination diet support materials.
Intervention: Functional Medicine Health Coaching for Elimination Diet for Elimination Diet (Behavioral)
Self-guided Elimination Diet
Participants randomized into the "Self-guided Elimination Diet" group will engage with the elimination diet without health coaching. All study arms will receive written elimination diet support materials.
Intervention: Self-guided Elimination Diet (Behavioral)
Outcomes
Primary Outcomes
Change from baseline PROMIS-Global Health score
Time Frame: 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.
Secondary Outcomes
- Change from baseline Medical Symptoms Questionnaire (MSQ) score(Change from baseline at 10 weeks)
- Adherence/compliance to the elimination diet(At 10 weeks)