Integrative Medicine for Hypermobility Spectrum Disorder and Ehlers-Danlos Syndromes (IMforHSDandEDS)
- Conditions
- EDSEhlers-Danlos SyndromeHypermobility SyndromeHypermobile EDS (hEDS)
- Interventions
- Behavioral: Anti-inflammatory (Mediterranean-style) dietBehavioral: Behavioral and psychosocial support
- Registration Number
- NCT04734041
- Lead Sponsor
- National University of Natural Medicine
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Integrative Medicine Behavioral and psychosocial support Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support. Integrative Medicine Anti-inflammatory (Mediterranean-style) diet Anti-inflammatory (Mediterranean) diet, as well as general behavioral and psychosocial support.
- Primary Outcome Measures
Name Time Method Recruitment rate 9 weeks Number of participants enrolled per month, over the 4 month open recruitment
Retention rate 9 weeks Proportion of participants completing the mid-study or end-of-study visits
- Secondary Outcome Measures
Name Time Method Adherence to food tracking 5, 9 weeks Reporting per week of dietary intake recorded in a food tracker app
Adherence to the dietary recommendations 5, 9 weeks Estimated daily dietary intake recorded in a food tracker app
Trial Locations
- Locations (2)
Healthy Living Community
🇺🇸Portland, Oregon, United States
National University of Natural Medicine
🇺🇸Portland, Oregon, United States