Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea
NCT ID: NCT06705413
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
71 participants
INTERVENTIONAL
2024-11-30
2025-06-30
Brief Summary
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Detailed Description
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Obesity in women adolescents is one of the factors associated with dysmenorrhea also; Endometrium production of physiological prostaglandin increased in primary dysmenorrhea. Increased prostaglandin directly contributes to uterine contractions that eventually lead to primary dysmenorrhea. Overweight and obesity thought to be correlated with dysmenorrhea by increasing the development of prostaglandin.
The Microbiome Diet is a new, trendy weight loss diet. It created by Dr. Raphael Kellman and based on eating and avoiding certain foods in the hopes of restoring gut health. It's also claimed to offer other benefits, such as a faster metabolism and weight loss. Therefore, this study aims to investigate the effect of lifestyle modification on obese females suffering from primary dysmenorrhea
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Aerobic exercise group
The participants will receive a program of aerobic exercise for 3 consecutive menstrual cycles.
Aerobic exercise
a program consists of 10 minutes warming up, 30 minutes of aerobic exercises in the form of core strengthening exercises and stretching exercises and finally 10 minutes of cooling down. The participant will receive the aerobic program 4 sessions /week for three consecutive menstrual cycles.
Aerobic exercise and microbiome diet group
The participants will receive aerobic exercise in addition to microbiome diet for 3 consecutive menstrual cycles.
Aerobic exercise
a program consists of 10 minutes warming up, 30 minutes of aerobic exercises in the form of core strengthening exercises and stretching exercises and finally 10 minutes of cooling down. The participant will receive the aerobic program 4 sessions /week for three consecutive menstrual cycles.
Microbiome diet
The participants will receive Microbiome diet for three consecutive menstrual cycles. A three-phase diet (21-day phase, 28-day phase and maintenance phase) will be followed by the experimental group which contains some food restrictions and addition for certain food types which may improve gut health.
Interventions
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Aerobic exercise
a program consists of 10 minutes warming up, 30 minutes of aerobic exercises in the form of core strengthening exercises and stretching exercises and finally 10 minutes of cooling down. The participant will receive the aerobic program 4 sessions /week for three consecutive menstrual cycles.
Microbiome diet
The participants will receive Microbiome diet for three consecutive menstrual cycles. A three-phase diet (21-day phase, 28-day phase and maintenance phase) will be followed by the experimental group which contains some food restrictions and addition for certain food types which may improve gut health.
Eligibility Criteria
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Inclusion Criteria
* Virgin, nonsmokers.
* Young female aged from 18-25 years with BMI more than 30 kg/m².
* They have regular menstrual cycles (a menstrual flow of 38 days, with 21-35 days between menstrual flows)
* They have not practiced sports for at least one year before entering the study.
* They have not engaged in diet for at least one year before entering the study.
Exclusion Criteria
* Any participant with a history of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease.
* Any participant with a history of previous spinal surgeries.
* Any participant with a history of Anemia, diabetes, hypertension, cardiovascular disease, thyroid disease, neurological disorder, rheumatoid arthritis, bariatric surgery, or taking weight loss medication.
18 Years
25 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Noha Taha Abd EL-Hamed
Principal investigator
Principal Investigators
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Doaa Osman, professor
Role: STUDY_DIRECTOR
Cairo University
Amel Yousef, Professor
Role: STUDY_CHAIR
Cairo University
Locations
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Noha Taha Abd El-Hamed
Ismailia, , Egypt
Countries
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Central Contacts
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Other Identifiers
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P.T.REC/012/005311
Identifier Type: -
Identifier Source: org_study_id