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临床试验/NCT06724419
NCT06724419已完成不适用

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

Universiti Tunku Abdul Rahman1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
1
主要终点
premenstrual syndrome severity

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Nutrition education-based intervention (Behavioral)

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.

结局指标

主要结局

premenstrual syndrome severity

时间窗: 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.

Premenstrual syndrome severity

时间窗: 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.

次要结局

  • 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)
  • Physical activity(Baseline, Immediate post, after 1 month and 3 months after Intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Foo Chai Nien

Assistant Professor

Universiti Tunku Abdul Rahman

研究点 (1)

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