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

Tunku Abdul Rahman University (UTAR)

Status: Enrolling

Conditions: Premenstrual Syndrome-PMS

Treatments: Behavioral: Nutrition education-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06724419

U/SERC/56(A)-432/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Nutrition education-based intervention

Control group

No Intervention group

Description:

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