Functional Medicine Health Coaching

NCT05551546 | Completed

• 1 other identifier: EliminationDietRCT1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Promotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline Medical Symptoms Questionnaire (MSQ) score

  Change from baseline at 10 weeks

• Adherence/compliance to the elimination diet

  At 10 weeks

Study Arms (2)

Functional Medicine Health Coaching for Elimination Diet

ACTIVE COMPARATOR

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.

Behavioral: Functional Medicine Health Coaching for Elimination Diet for Elimination Diet

Self-guided Elimination Diet

OTHER

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.

Behavioral: Self-guided Elimination Diet

Interventions

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.

Functional Medicine Health Coaching for Elimination Diet

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.

Self-guided Elimination Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Eating disorders within the past 10 years
• Currently pregnant or breastfeeding
• Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants

Sponsors & Collaborators

• The Institute for Functional Medicine: lead
• Functional Medicine Coaching Academy: collaborator

Study Sites (1)

The Institute for Functional Medicine

Federal Way, Washington, 98003, United States

Location

MeSH Terms

Interventions

Elimination Diets

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sandra Scheinbaum, PhD

  Functional Medicine Coaching Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 22, 2022
• Study Start: September 26, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)