Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea

NCT06705413 | Completed

• 1 other identifier: P.T.REC/012/005311
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (5)

• Pain level assessment

  The visual analogue scale will be used to measure menstrual pain intensity for both groups before and after treatment.it is a valid and reliable 10 cm line ranging from 0 to 10. 0 indicates no pain,10 indicates worst pain.

  3 months

• Assessment of severity of dysmenorrhea

  WaLIDD scale will be used to determine the severity of dysmenorrhea for each female in both groups by combining subjective (intensity/wong-baker, work ability) and objective (days of pain, location) manifestations for both groups. its score ranges between 0 and 3, and the final score ranges from 0 to 12 points. the higher the score, the greater the severity of dysmenorrhea.

  3 months

• Assessment of pain pressure threshold

  the pressure algometer will be used to assess pain pressure threshold for all females in both groups before and after treatment on the following points: A-Two measurements 4cm from the umbilicus, bilaterally (points I and II) B-Two other measurements 4cm below the previous ones (points III and IV) C. A single measurement 4cm from the lower margin of the umbilicus (point V). D. Another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, corresponding to S2-S4 (point VI).

  3 months

• Body mass index

  Weight and height measurement will be measured for each participant in both groups before and after the treatment to calculate her BMI according to the following equation: BMI (kg/m2) = Weight (kg) / Height² (m2).

  3 months

• Waist and hip ratio measurement:

  Waist hip circumference were taken for each woman in both groups before and after the treatment course for calculating waist and hip ratio (WHR) by dividing the waist circumference (WC) on hip circumference (HC). By the tape measurement, (WC) was measured at the narrowest circumference between xipho-sternum and the iliac crest at the end of gentle expiration. HC was measured at the maximum circumference at the level of femoral trochanter.

  3 months

Secondary Outcomes (3)

• Measurement of lumbar mobility

  3 months

• Measurement of lumbar lordotic curve

  3 months

• Assessment of Health-Related Quality of Life

  3 months

Study Arms (2)

Aerobic exercise group

ACTIVE COMPARATOR

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

Other: Aerobic exercise

Aerobic exercise and microbiome diet group

EXPERIMENTAL

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

Other: Aerobic exercise; Other: Microbiome diet

Interventions

Aerobic exercise OTHER

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; Aerobic exercise group

Microbiome diet OTHER

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.

Aerobic exercise and microbiome diet group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Noha Taha Abd El-Hamed

Ismailia, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Doaa Osman, professor

  Cairo University

  STUDY DIRECTOR

• Amel Yousef, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: January 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

EG (1)