Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea

Cairo University (CU)

Status: Not yet enrolling

Conditions: Primary Dysmenorrhea

Treatments: Other: Microbiome diet; Other: Aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06705413

P.T.REC/012/005311

Details and patient eligibility

About

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

Full 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

Enrollment: 71 estimated patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Aerobic exercise group

Active Comparator group

Description:

The participants will receive a program of aerobic exercise for 3 consecutive menstrual cycles.

Treatment:

Other: Aerobic exercise

Aerobic exercise and microbiome diet group

Experimental group

Description:

The participants will receive aerobic exercise in addition to microbiome diet for 3 consecutive menstrual cycles.

Treatment:

Other: Aerobic exercise

Other: Microbiome diet