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

Not Applicable

Not yet recruiting

• Conditions: Premenstrual Syndrome-PMS

• Registration Number: NCT06724419
• Lead Sponsor: Universiti Tunku Abdul Rahman

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

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 Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
premenstrual syndrome severity	Baseline, Immediate post, after 1 month and 3 months after Intervention	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.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress	Baseline, Immediate post, after 1 month and 3 months after Intervention	Perceived Stress Scale (PSS): Low stress (0-13), moderate stress (14-26), and high stress (27-40)
physical activity	Baseline, Immediate post, after 1 month and 3 months after Intervention	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.
Dietary intake quality	Baseline, Immediate post, after 1 month and 3 months after Intervention	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.

Trial Locations

Locations (1)

Hainan Vocational University of Science and Technology; 🇨🇳 Haikou, Hainan, China