Integrative Medicine for Hypermobility Spectrum Disorder and Ehlers-Danlos Syndromes (IMforHSDandEDS)

Study Overview
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Brief Summary
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A feasibility study of an integrative medicine program among patients with Hypermobility Spectrum Disorder (HSD) or Ehlers-Danlos syndromes (EDS)

Detailed Description
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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.

Official Title
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Integrative Medicine for Hypermobility Spectrum Disorder (HSD) and Ehlers-Danlos (EDS) Syndromes: A Mixed-methods Feasibility Study

Conditions
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Ehlers-Danlos Syndrome, Hypermobile EDS (hEDS), Hypermobility Syndrome, EDS

Intervention / Treatment
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* Behavioral: Anti-inflammatory (Mediterranean-style) diet
* Behavioral: Behavioral and psychosocial support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Integrative Medicine<br>Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support. | Behavioral: Anti-inflammatory (Mediterranean-style) diet<br>* 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.<br>Behavioral: Behavioral and psychosocial support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number of participants enrolled per month, over the 4 month open recruitment | 9 weeks | 
| Retention rate | Proportion of participants completing the mid-study or end-of-study visits | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the dietary recommendations | Estimated daily dietary intake recorded in a food tracker app | 5, 9 weeks | 
| Adherence to food tracking | Reporting per week of dietary intake recorded in a food tracker app | 5, 9 weeks |