Functional Medicine Health Coaching

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Health Promotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Functional Medicine Health Coaching for Elimination Diet for Elimination Diet

Intervention Type BEHAVIORAL

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

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.

Group Type OTHER

Self-guided Elimination Diet

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes