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

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

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome-PMS
• Intervention / Treatment: Behavioral: Nutrition education-based intervention

Detailed Description

Premenstrual syndrome (PMS), occurring during the luteal phase of the menstrual cycle and spontaneously resolving after menstruation begins, is a prevalent psychological and somatic disorder among women of reproductive age.Lifestyle modifications can help alleviate PMS symptoms, including dietary changes (such as reducing salt and sugar intake or increasing consumption of vegetables and fruits), engaging in regular physical activity, stress management, and avoiding smoking.This study is a parallel, unblinded, randomized controlled trial assessing the efficacy of nutrition education-based intervention on PMS severity, perceived stress, and lifestyle-related outcomes in Chinese college students. Participants will be randomly assigned to two groups: the nutrition education-based intervention group (NEI) and the control group. The nutrition education-based intervention program will span 6 weeks. The participants in the "passive" control group will receive no further intervention and will each be provided with The PMS Management Booklet. Data will be collected through online surveys at baseline, post-intervention, and at 1-month and 3-month follow-up points after the completion of the intervention. Data analysis will be performed using SPSS 26.0.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570100
      • Hainan Vocational University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Females students aged 18 to 30 years
2. PMS scores（6-36）
3. Regular menstrual cycles (defined as a menstrual cycle of 21 to 35 days)
4. 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
5. No participation in interventional studies related to premenstrual syndrome in the past 6 months

Exclusion Criteria:

1. Amenorrhea
2. Polycystic ovarian disease (PCOD)
3. Those who are unable to attend according to intervention protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The participants in the "passive" control group will receive no further intervention and will each be provided with The PMS Management Booklet.
Experimental: Intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress	Perceived Stress Scale (PSS): Low stress (0-13), moderate stress (14-26), and high stress (27-40)	Baseline, Immediate post, after 1 month and 3 months after Intervention
Dietary intake quality	Chinese Healthy Eating Index (CHEI);The total score, ranging from 0 to 100, summarizes all 17 components, with a higher score indicating better diet quality.	Baseline, Immediate post, after 1 month and 3 months after Intervention
Physical activity	International physical activity questionnaire-short form (IPAQ-SF) ;MET-minutes/week will be used as a measure of the volume of activity. Total physical activity MET-minutes/week will be calculated as the sum of Walking + Moderate + Vigorous MET-minutes/week scores.	Baseline, Immediate post, after 1 month and 3 months after Intervention

Collaborators and Investigators

• Sponsor: Universiti Tunku Abdul Rahman

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): July 4, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Premenstrual Syndrome
• Other Study ID Numbers: U/SERC/56(A)-432/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No