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Effect of Mediterranean Diet and Physical Activity in Patients With Endometriosis (PHAMEDENDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994432
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:
The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating scale, NRS ≥ 4), in therapy with estrogen-progestins or progestins.

Condition or disease Intervention/treatment Phase
Endometriosis Behavioral: intervention group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Mediterranean Diet and Physical Activity in Patients With Symptomatic Endometriosis in Therapy With Estrogen-progestins or Progestins: a Randomized Controlled Trial
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
patients with symptomatic endometriosis in therapy with estro-progestins or progestins, who will be asked to follow a mediterranean diet and to practice an aerobic physical exercise according to the "7-minutes workout" model
Behavioral: intervention group
follow a mediterranean diet and practice a regular aerobic exercise according to the "7-minutes workout" model.

No Intervention: Control group
patients with symptomatic endometriosis in therapy with estro-progestins or progestins.



Primary Outcome Measures :
  1. Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]
    The presence and severity of dysmenorrhea, deep dyspareunia, and non-menstrual pelvic pain will be assessed using an 11-point numeric rating scale (NRS), with 0 indicating absence of pain and 10 pain as bad as it could be. Scores 1 to 4 will be considered mild pain, 5 to 7 moderate pain, and 8 to 10 severe pain. Patients will be considered for enrollment if they complained of at least moderate or severe pelvic pain (NRS score ≥ 4).


Secondary Outcome Measures :
  1. The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]
    Patients will rate the degree of satisfaction with their treatment according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).

  2. Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]
    To determine states of anxiety and depression we'll use the Hospital Anxiety and Depression Scale (HADS) that is a self-assessment mood scale specifically designed for use in non-psychiatric hospital outpatients. It comprises 14 questions, 7 for the anxiety subscale and 7 for the depression subscale. Lower scores indicate better psychological status.

  3. Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity [ Time Frame: 12 months ]
    We'll use the Female Sexual Function Index (FSFI) questionnaire that is a 19-item, multidimensional, self-report instrument for evaluating the main categories of female sexual dysfunction and sexual satisfaction. Domains include desire, arousal, lubrication, orgasm, satisfaction and pain. Each domain is scored on a scale of 1 to 5, and the maximum transformed full-scale score is 36, with a minimum full-scale score of 2.0. Women with a FSFI total score below 26.55 are categorized as experiencing sexual dysfunction

  4. Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity. [ Time Frame: 12 months ]
    Quality of life will be assessed with the Short-Form 12 (SF-12) health survey, developed from the original SF-36 questionnaire, a well-known, validated self-administered 12-item instrument. It measures health dimensions covering functional status, well-being, and overall health. Information from the 12 items is used to construct physical (PCS-12) and mental (MCS-12) component summary measures, with higher scores indicating better health perception.

  5. Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity. [ Time Frame: 12 months ]
    Overall improvement will be assessed by participants using the Patient Global Impression of Change scale, a 7-point categorical scale recommended for use in chronic pain studies as a core outcome measure of global improvement over time.According to this single-item rating system, the response during treatment is indicated by choosing one among seven alternative options, i.e., "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse."



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 45 years
  • body mass index between 18 and 29.9
  • women with symptomatic endometriosis (pelvic pain with NRS score ≥ 4), in therapy with estro-progestins or progestins
  • not seeking conception

Exclusion Criteria:

  • associated diseases that cause pelvic pain regardless of the presence of endometriosis, or chronic intestinal diseases (Crohn's disease or ulcerative rectocolitis).
  • patients in note for all kind of surgery
  • women who conduct a strong physical activity.
  • women who follow vegetarian-vegan diet regimens.
  • metabolic diseases that require specific dietary indications (diabetes and celiac disease, food allergies).
  • medical contraindications to proposed physical activity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994432


Contacts
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Contact: Laura Buggio, MD 0255032917 buggiolaura@gmail.com
Contact: Elena Roncella, MD 3923178054 elenaroncella87@gmail.com

Locations
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Italy
Laura Buggio Centro Endometriosi e Metrorragie Clinica Mangiagalli, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Laura Buggio, MD, PhD    +39 02 55032917    phamedendo@gmail.com   
Contact: Elena Roncella, MD, PhD    +39 02 55032917    elenaroncella87@gmail.com   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03994432    
Other Study ID Numbers: 833_2018bis
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
mediterranean diet
endometriosis
physical activity
7 minutes work-out
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female