Clinical trial NCT06724419: Efficacy of Nutrition Education in Alleviating Premenstrual Syndrome (PMS) Among Chinese College Students at Hainan University, China
Official title: Efficacy of Nutrition Education in Alleviating Premenstrual Syndrome (PMS) Among Chinese College Students at Hainan University, China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premenstrual Syndrome-PMS
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: premenstrual syndrome severity
timeFrame: Baseline, Immediate post, after 1 month and 3 months after Intervention
Secondary outcomes:
measure: Perceived Stress
timeFrame: Baseline, Immediate post, after 1 month and 3 months after Intervention
measure: physical activity
timeFrame: Baseline, Immediate post, after 1 month and 3 months after Intervention
measure: Dietary intake quality
timeFrame: Baseline, Immediate post, after 1 month and 3 months after Intervention
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Vocational University of Science and Technology
state: Hainan
Study officials:
References: