Functional Medicine Health Coaching

Health Promotion Clinical Trial

Official title:

Effect of Functional Medicine Health Coaching on Self-Reported Measures of Physical and Emotional Health: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551546
• Other study ID #: EliminationDietRCT1
• Status: Completed
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: The Institute for Functional Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Promotion

Intervention

Behavioral:
• Functional Medicine Health Coaching for Elimination Diet for Elimination Diet
All participants will receive 5 coaching sessions to support them through the elimination diet. First session: The foundation session is where the coach and participant begin to develop rapport and outline the participant's goals. This occurs before the start of the Elimination Diet for motivation, expectations, education, and preparation. Second session: This can occur during week 1 of the elimination diet to support working through the implementation. Third session: This session is recommended to occur during week 3 of the diet to prepare for the reintroduction of foods. Fourth session: A session is recommended while the participant is reintroducing foods as this is typically the most difficult part of the diet as participants may be experiencing symptoms to reactive foods. Fifth session: A wrap up session is recommended after all of the food re-introductions to support the participant with maintenance, goals to move forward, and reflection.
• Self-guided Elimination Diet
The Elimination Diet course materials include self-guided materials designed to guide participants through all phases of a comprehensive elimination diet, including preparation, elimination, and reintroduction phases. All participants in this wait-list control group will be presented via email with the opportunity to receive the five sessions of coaching (described above) at the conclusion of the study.

Locations

Country	Name	City	State
United States	The Institute for Functional Medicine	Federal Way	Washington

Sponsors (2)

Lead Sponsor	Collaborator
The Institute for Functional Medicine	Functional Medicine Coaching Academy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline PROMIS-Global Health score	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.	Change from baseline at 10 weeks
Secondary	Change from baseline Medical Symptoms Questionnaire (MSQ) score	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.	Change from baseline at 10 weeks
Secondary	Adherence/compliance to the elimination diet	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.	At 10 weeks