Ehlers-Danlos SyndromeNCT04734041
Integrative Medicine for Hypermobility Spectrum Disorder and Ehlers-Danlos Syndromes (IMforHSDandEDS)
A study testing Anti-inflammatory (Mediterranean-style) diet and Behavioral and psychosocial support in people with Ehlers-Danlos Syndrome and Hypermobile EDS (hEDS), run by National University of Natural Medicine at 2 sites in United States.
Trial summary
A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ehlers-Danlos Syndrome, Hypermobile EDS (hEDS), Hypermobility Syndrome
- What is being tested?
- Anti-inflammatory (Mediterranean-style) diet and Behavioral and psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Dec 2020to 2 Jul 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Beighton score of 4 or more to confirm joint hypermobility diagnosis
- Baseline VAS Score of 1 or more
- Not currently, or already a patient of Dr. Schaefer and Healthy Living Community
- Ability to provide written informed consent
- Willingness to participate in 9-week integrative medicine intervention (and make dietary and lifestyle changes)
- Willingness to attend 1 in-person screening visit and 2 virtual office visits (or 3 virtual visits, if medical documentation of Beighton score can be provided in advance of enrollment, and all other criteria are met)
- Access to an electronic device for MyFitnessPal food-tracker use (i.e mobile device, tablet, laptop)
Who cannot join
- Pregnant and lactating women, or planned pregnancy over the next 3 months
- Consumption of more than 14 (men) or 7 (women) alcoholic drinks per week
- History of disordered eating or eating disorder
- Body mass index (BMI) considered underweight (<18.5)
- Weight loss from metastatic cancer
- Unable to make dietary changes or participate in a 9-integrative medicine nutritional intervention
- Those with significant dietary changes, new medications, or new exercise routines within the past 90 days
- Currently, or already, a patient of Dr. Schaefer and Healthy Living Community
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National University of Natural Medicine
Portland, Oregon, 97201
Healthy Living Community
Portland, Oregon, 97202
About this study
Official title: Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study
A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)
Read the detailed description
The overall purpose of this study is to assess the feasibility of conducting a 9-week integrative medicine program that is comprised of a prescribed anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS), in order to determine the recruitment potential in this population and to measure the ability of individuals to complete the program. Participants will be prescribed a food plan, and adherence to and feasibility of the food plan will be measured through participant food tracking and a subjective assessment of the food plan in a brief satisfaction survey.
This study aims to recruit 20 patients with HSD or EDS and make preliminary observations regarding the effects of integrative medical care on pain reduction and improved quality of life.
- Being tested
- Anti-inflammatory (Mediterranean-style) diet, Behavioral and psychosocial support
- Medical subject headings
- Ehlers-Danlos Syndrome, Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory (Mediterranean-style) dietBehavioural
Prescription of an anti-inflammatory diet, which encourages increasing whole fruits, vegetables, and grains, as well as balancing macronutrients (proteins, carbohydrates, and fat) for every meal.
Behavioral and psychosocial supportBehavioural
Capture a complete and detailed medical history and background. Discuss familial and social support, provide psychosocial support, assess the patient's current self-management strategies for self-care, and assess the patient's current self-management strategies for mental health. Recommendations will be made in accordance with the needs of the participant.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Medicine | Other | Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support. Receives: Behavioral: Anti-inflammatory (Mediterranean-style) diet; Behavioral: Behavioral and psychosocial support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants enrolled per month, over the 4 month open recruitment
Measured: 9 weeks
Retention rate
Proportion of participants completing the mid-study or end-of-study visits
Measured: 9 weeks
Secondary outcomes (2)
Adherence to the dietary recommendations
Estimated daily dietary intake recorded in a food tracker app
Measured: 5, 9 weeks
Adherence to food tracking
Reporting per week of dietary intake recorded in a food tracker app
Measured: 5, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start23 Dec 2020
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Living Community
- Responsible party
- Principal investigator, Douglas Hanes, National University of Natural Medicine
- Investigators
- Rich Barrett, ND, Study chair, NUNM Institutional Review Board Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734041
- Sponsor's protocol ID
- DH10320
- Status last verified
- Jul 2021
- First submitted
- 22 Jan 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guedry SE, Langley BO, Schaefer K, Hanes DA. Integrative medicine for hypermobility spectrum disorders (HSD) and Ehlers-Danlos syndromes (EDS): a feasibility study. Disabil Rehabil. 2024 Dec;46(24):5854-5867. doi: 10.1080/09638288.2024.2314713. Epub 2024 Feb 14.
PubMed 38353245
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT04734041
- Acronym / sponsor ID
- DH10320
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Healthy Living Community
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 2 Feb 2021 (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.
A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)
Detailed description
The overall purpose of this study is to assess the feasibility of conducting a 9-week integrative medicine program that is comprised of a prescribed anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS), in order to determine the recruitment potential in this population and to measure the ability of individuals to complete the program. Participants will be prescribed a food plan, and adherence to and feasibility of the food plan will be measured through participant food tracking and a subjective assessment of the food plan in a brief satisfaction survey.
This study aims to recruit 20 patients with HSD or EDS and make preliminary observations regarding the effects of integrative medical care on pain reduction and improved quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Integrative Medicine | Other | Behavioral: Anti-inflammatory (Mediterranean-style) diet, Behavioral: Behavioral and psychosocial supportAnti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65
- Beighton score of 4 or more to confirm joint hypermobility diagnosis
- Baseline VAS Score of 1 or more
- Not currently, or already a patient of Dr. Schaefer and Healthy Living Community
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Pregnant and lactating women, or planned pregnancy over the next 3 months
- Consumption of more than 14 (men) or 7 (women) alcoholic drinks per week
- History of disordered eating or eating disorder
- Body mass index (BMI) considered underweight (<18.5)
- Weight loss from metastatic cancer
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 |
|---|---|---|
| Anti-inflammatory (Mediterranean-style) dietPrescription of an anti-inflammatory diet, which encourages increasing whole fruits, vegetables, and grains, as well as balancing macronutrients (proteins, carbohydrates, and fat) for every meal. | Behavioural | Integrative Medicine |
| Behavioral and psychosocial supportCapture a complete and detailed medical history and background. Discuss familial and social support, provide psychosocial support, assess the patient's current self-management strategies for self-care, and assess the patient's current self-management strategies for mental health. Recommendations will be made in accordance with the needs of the participant. | Behavioural | Integrative Medicine |
Primary outcome
Recruitment rate
Time frame: 9 weeks
Number of participants enrolled per month, over the 4 month open recruitment
Retention rate
Time frame: 9 weeks
Proportion of participants completing the mid-study or end-of-study visits
2 secondary outcomes
Adherence to the dietary recommendations
Time frame: 5, 9 weeks
Adherence to food tracking
Time frame: 5, 9 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 15 Jul 2021.
- Derived from this study: PubMed 38353245Guedry SE, Langley BO, Schaefer K, Hanes DA. Integrative medicine for hypermobility spectrum disorders (HSD) and Ehlers-Danlos syndromes (EDS): a feasibility study. Disabil Rehabil. 2024 Dec;46(24):5854-5867. doi: 10.1080/09638288.2024.2314713. Epub 2024 Feb 14.
- 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.
Rich Barrett, ND study chair
NUNM Institutional Review Board Chair
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory (Mediterranean-style) diet and Behavioral and psychosocial support in people with Ehlers-Danlos Syndrome and Hypermobile EDS (hEDS), run by National University of Natural Medicine at 2 sites 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 8 inclusion and 8 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Recruitment rate (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734041, which also lists 1 linked publication.
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 15 Jul 2021.