Clinical trial NCT06705413: Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea
Official title: Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be designed to determine the effect of lifestyle modification on primary dysmenorrhea in obese females.

Detailed description: Menstruation in women after puberty is often confused with dysmenorrhea. Primary dysmenorrhea, where there is no apparent pelvic pathology, is characterized as painful menstrual cramps. This symptom typically occurs within one to two years of menarche and menstrual cycle stabilisation1. Pain occurs a couple of hours before or after menstruation and lasts for 12 to 72 hours. Dysmenorrhea can also be accompanied by nausea, discomfort, low back pain, or flank pain.

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

Eligibility criteria: Inclusion Criteria:

* Young females with moderate to severe primary dysmenorrhea (Visual analogue scale \> 4).
* 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 having Secondary dysmenorrhea (associated with identifiable pelvic pathology).
* 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.

Primary outcomes:
measure: Pain level assessment
timeFrame: 3 months
measure: Assessment of severity of dysmenorrhea
timeFrame: 3 months
measure: Assessment of pain pressure threshold
timeFrame: 3 months
measure: Body mass index
timeFrame: 3 months
measure: Waist and hip ratio measurement:
timeFrame: 3 months
Secondary outcomes:
measure: Measurement of lumbar mobility
timeFrame: 3 months
measure: Measurement of lumbar lordotic curve
timeFrame: 3 months
measure: Assessment of Health-Related Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Noha Taha Abd El-Hamed
Study officials:
affiliation: Cairo University
name: Doaa Osman, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Amel Yousef, Professor
role: STUDY_CHAIR
References: