Skip to main content
OpenTrials
Completed

NCT Number: NCT05551546

Functional Medicine Health Coaching

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Health Promotion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Institute for Functional Medicine

Federal Way, Washington, 98003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Medicine Health Coaching for Elimination Diet for Elimination Diet

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

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.

Primary outcomes

  1. 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

  1. Change from baseline Medical Symptoms Questionnaire (MSQ) score

    Time frame: 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.

  2. Adherence/compliance to the elimination diet

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Institute for Functional Medicine

Other

Collaborators

  • Functional Medicine Coaching Academy

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.