Functional Medicine Health Coaching

Not Applicable

Completed

• Conditions: Health Promotion
• Interventions: Behavioral: Self-guided Elimination Diet; Behavioral: Functional Medicine Health Coaching for Elimination Diet for Elimination Diet

• Registration Number: NCT05551546
• Lead Sponsor: The Institute for Functional Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Study Start: 2022-09-26
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-guided Elimination Diet	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.
Functional Medicine Health Coaching for Elimination Diet	Functional Medicine Health Coaching for Elimination Diet 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.

Primary Outcome Measures

Name	Time	Method
Change from baseline PROMIS-Global Health score	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 Outcome Measures

Name	Time	Method
Change from baseline Medical Symptoms Questionnaire (MSQ) score	Change from baseline at 10 weeks	The Medical Symptoms Questionnaire is a multi-system inventory that rates symptom severity on a 0-4 scale. The MSQ has been used to track subjective responses of patients to treatment in both clinical and research settings.
Adherence/compliance to the elimination diet	At 10 weeks	The Adherence/compliance assessment is a 0-10 scale that asks the participant one question to self-rate how well they followed the Elimination Diet. This has been used in the Healthy Diet and Lifestyle Study pilot, a randomized trial.

Trial Locations

Locations (1)

The Institute for Functional Medicine; 🇺🇸 Federal Way, Washington, United States