Efficacy of Nutrition Education in Alleviating Premenstrual Syndrome (PMS) Among Chinese College Students at Hainan University, China

NCT06724419 | Completed

• 1 other identifier: U/SERC/56(A)-432/2024
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of nutrition education-based intervention on PMS severity, perceived stress, and lifestyle-related outcomes among the students at Hainan Vocational University of Science and Technology

Conditions

Premenstrual Syndrome-PMS

Outcome Measures

Primary Outcomes (1)

• Premenstrual syndrome severity

  Premenstrual Syndrome Scale (PMSS): A total score of 6-10 on the questionnaire indicated mild PMS, 11-20 indicated moderate PMS, and more than 20 indicated severe PMS.

  Baseline, Immediate post, after 1 month and 3 months after Intervention

Secondary Outcomes (3)

• Perceived Stress

  Baseline, Immediate post, after 1 month and 3 months after Intervention

• Physical activity

  Baseline, Immediate post, after 1 month and 3 months after Intervention

• Dietary intake quality

  Baseline, Immediate post, after 1 month and 3 months after Intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

The nutrition education-based intervention program will span 6 weeks, providing participants with comprehensive nutrition education based on dietary guidelines and comprising 8 topics , each lasting approximately 60-120 minutes. The aim is to comprehensively promote participants' adoption of a healthy lifestyle through various educational interventions, and each participant will be provided with the PMS management booklet.

Behavioral: Nutrition education-based intervention

Control group

NO INTERVENTION

The participants in the "passive" control group will receive no further intervention and will each be provided with The PMS Management Booklet.

Interventions

Nutrition education-based intervention BEHAVIORAL

The nutrition education-based intervention program will span 6 weeks, providing participants with comprehensive nutrition education based on dietary guidelines and comprising 8 topics , each lasting approximately 60-120 minutes.The aim is to comprehensively promote participants' adoption of a healthy lifestyle through various educational interventions, and each participant will be provided with the PMS management booklet.

Intervention group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females students aged 18 to 30 years
• PMS scores（6-36）
• Regular menstrual cycles (defined as a menstrual cycle of 21 to 35 days)
• Not using hormonal compounds (such as contraceptive pills), drugs (such as fluoxetine and escitalopram), or non-drug treatments affecting premenstrual syndrome, such as special diets
• No participation in interventional studies related to premenstrual syndrome in the past 6 months

You may not qualify if:

• Amenorrhea
• Polycystic ovarian disease (PCOD)
• Those who are unable to attend according to intervention protocol

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

Hainan Vocational University of Science and Technology

Haikou, Hainan, 570100, China

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: February 24, 2025
• Primary Completion: April 4, 2025
• Study Completion: July 4, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)