Health PromotionNCT05551546
Functional Medicine Health Coaching
A study testing Functional Medicine Health Coaching for Elimination Diet for Elimination Diet and Self-guided Elimination Diet in people with Health Promotion, run by The Institute for Functional Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Functional Medicine Health Coaching for Elimination Diet for Elimination Diet and Self-guided Elimination Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Eating disorders within the past 10 years
- Currently pregnant or breastfeeding
- Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute for Functional Medicine
Federal Way, Washington, 98003
About this study
Official title: Effect of Functional Medicine Health Coaching on Self-Reported Measures of Physical and Emotional Health: A Randomized Controlled Trial.
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
- Being tested
- Functional Medicine Health Coaching for Elimination Diet for Elimination Diet, Self-guided Elimination Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Medicine Health Coaching for Elimination Diet for Elimination DietBehavioural
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 DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-guided Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 10 weeks
Secondary outcomes (2)
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.
Measured: Change from baseline at 10 weeks
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.
Measured: At 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start26 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Institute for Functional Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Functional Medicine Coaching Academy
- Responsible party
- Sponsor
- Investigators
- Sandra Scheinbaum, PhD, Principal investigator, Functional Medicine Coaching Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551546
- Sponsor's protocol ID
- EliminationDietRCT1
- Status last verified
- Dec 2022
- First submitted
- 16 Sep 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Medicine Health Coaching on Self-Reported Measures of Physical and Emotional Health: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05551546
- Acronym / sponsor ID
- EliminationDietRCT1
- Conditions
- Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Institute for Functional MedicineUniversity, hospital or other
- Collaborators
- Functional Medicine Coaching Academy
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Medicine Health Coaching for Elimination Diet | Active comparator | Behavioral: Functional Medicine Health Coaching for Elimination Diet for Elimination DietParticipants 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. |
| Self-guided Elimination Diet | Other | Behavioral: Self-guided Elimination DietParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Eating disorders within the past 10 years
- Currently pregnant or breastfeeding
- Nursing home residents, other institutionalized persons, prisoners, any other vulnerable participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Medicine Health Coaching for Elimination Diet for Elimination DietAll 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. | Behavioural | Functional Medicine Health Coaching for Elimination Diet |
| Self-guided Elimination DietThe 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. | Behavioural | Self-guided Elimination Diet |
Primary outcome
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.
2 secondary outcomes
Change from baseline Medical Symptoms Questionnaire (MSQ) score
Time frame: Change from baseline at 10 weeks
Adherence/compliance to the elimination diet
Time frame: At 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Scheinbaum, PhD principal investigator
Functional Medicine Coaching Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Medicine Health Coaching for Elimination Diet for Elimination Diet and Self-guided Elimination Diet in people with Health Promotion, run by The Institute for Functional Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline PROMIS-Global Health score (time frame: Change from baseline at 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.