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Development and Effects of College-based Lifestyle Modification Program for menstrual health of Korean young adult women with irregular menses

Status Approved

  • First Submitted Date

    2020/10/20

  • Registered Date

    2020/10/27

  • Last Updated Date

    2020/10/20

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005538
    Unique Protocol ID KU-IRB-18-83-A-1
    Public/Brief Title College-based Lifestyle Modification Program for menstrual health
    Scientific Title Development and Effects of College-based Lifestyle Modification Program for menstrual health of Korean young adult women with irregular menses
    Acronym College-based LMP
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KU-IRB-18-83-A-1
    Approval Date 2018-05-07
    Institutional Review Board Name Korea University Institutional Review Board
    Institutional Review Board Address 145, Anam-ro, Seongbuk-gu, Seoul
    Institutional Review Board Telephone 02-3290-1133
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young-Joo Park
    Title Professor
    Telephone +82-2-3290-4916
    Affiliation Korea University
    Address College of Nursing, 145 Anam-ro, Seongbuk-gu, Seoul, 02841, Korea
    Contact Person for Public Queries
    Name Inhae Cho
    Title Research Professor
    Telephone +82-2-3290-4912
    Affiliation Korea University
    Address College of Nursing, 145 Anam-ro, Seongbuk-gu, Seoul, 02841, Korea
    Contact Person for Updating Information
    Name Inhae Cho
    Title Research Professor
    Telephone +82-2-3290-4912
    Affiliation Korea University
    Address College of Nursing, 145 Anam-ro, Seongbuk-gu, Seoul, 02841, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2018-06-11 Actual
    Target Number of Participant 46
    Primary Completion Date 2018-12-31 , Actual
    Study Completion Date 2018-12-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Korea University
    Recruitment Status Completed
    Date of First Enrollment 2018-06-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Government
    Project ID No. NRF- 2017R1D1A1B
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose: This study was conducted to develop ‘College-based Lifestyle Modification Program’ (College-based LMP) for young adult women with irregular menstruation and examine its effects after intervention. 
    
    Methods: The College-based LMP consisted of small group education, individual physical exercise counseling/training, individual diet counseling, and feedback & support. Participants were comprised of 38 female who reported less than 10 times of irregular menstruations in a year and were randomly assigned to experimental- and control group. The primary outcome variables consisted of menstrual cycle index (MCI), sex hormone binding globulin (SHBG), and androgenic profile [testosterone (T), free androgen index (FAI)], while the outcome variables included premenstrual symptoms (PMS), menstrual volume, body composition parameters, glycemic parameters [fasting blood sugar (FBS), insulin, HOMA-IR], sleep duration, perceived stress, and nutrients intake. The data were analyzed by SAS and CAN_Pro.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Health Services Research
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    College-based LMP comprised of four sessions (small group education, individual physical exercise counseling/ training, individual diet counseling, and feedback & support). The contents in each session are as follows: 
     First, the small group education session provided small group of participants with the education on knowledge of menstruation to help them understand healthy menstruation. We developed a pamphlet entitled ‘Healthy menstruation and lifestyle’ for this session. Contents of the pamphlet included: ‘Understanding of female reproductive organs’, ‘Ovulation and physiology of menstruation’, ‘What is heathy menstruation?’, ‘Issues on healthy menstruation’, ‘Health issues related with abnormal menses (particularly for irregular menses, oligomenorrhea or secondary amenorrhea)’, ‘Relationship between menstruation and lifestyle’, and the ‘Lifestyle for menstrual health’. 
     Second, the session of ‘Individual physical exercise counseling/training’ intended for accomplishment of ‘Fit body mass’ based on analyses of individual body composition parameters which were identified at pre-test. The physical exercise comprised of aerobic exercise using treadmill and bicycle for 30~45 minutes, 3~4 times in a week and anaerobic exercise to reinforce muscle power, which were selected by the preference of individuals. The fitness center, located around the university, was provided as a place for exercises; the individuals participated in exercises at their own preferred times. 
     Third, in the ‘Individual diet counseling session’, the participants were provided with counselling on the intake of optimal calorie and balanced nutrition. This based on result of analyses on body composition parameters and nutrients intake of participants identified through pre-test in previous study [15]. We developed ‘Diet counselling record’ by individual. The title of developed ‘Diet counselling record’ was ‘What is the desirable nutrition for myself?’, and was comprised of following items: ‘How is my body composition and BMI?’, ‘The intake and evaluation on nutrients for myself (29 nutrients: calorie, macronutrients, fat-soluble/water-soluble vitamins, macro/micro minerals)’, and ‘Recommended dietary intake (RDI)’.
     Fourth, the feedback & support session provided the participants with rewards (complimentary mobile text and coupons) of positive feedback in cases of accomplishment of individual objectives, by the degree of participation in individual exercises every month.
    Number of Arms 2
    Arm 1

    Arm Label

    experimental group

    Target Number of Participant

    23

    Arm Type

    Experimental

    Arm Description

    College-based LMP comprised of four sessions (small group education, individual physical exercise counseling/ training, individual diet counseling, and feedback & support) and the period of the program was 6 months. The contents in each session are as follows: 
     First, the small group education session provided small group of participants with the education on knowledge of menstruation to help them understand healthy menstruation. We developed a pamphlet entitled ‘Healthy menstruation and lifestyle’ for this session. Contents of the pamphlet included: ‘Understanding of female reproductive organs’, ‘Ovulation and physiology of menstruation’, ‘What is heathy menstruation?’, ‘Issues on healthy menstruation’, ‘Health issues related with abnormal menses (particularly for irregular menses, oligomenorrhea or secondary amenorrhea)’, ‘Relationship between menstruation and lifestyle’, and the ‘Lifestyle for menstrual health’. 
     Second, the session of ‘Individual physical exercise counseling/training’ intended for accomplishment of ‘Fit body mass’ based on analyses of individual body composition parameters which were identified at pre-test. The physical exercise comprised of aerobic exercise using treadmill and bicycle for 30~45 minutes, 3~4 times in a week and anaerobic exercise to reinforce muscle power, which were selected by the preference of individuals. The fitness center, located around the university, was provided as a place for exercises; the individuals participated in exercises at their own preferred times. 
     Third, in the ‘Individual diet counseling session’, the participants were provided with counselling on the intake of optimal calorie and balanced nutrition. This based on result of analyses on body composition parameters and nutrients intake of participants identified through pre-test in previous study [15]. We developed ‘Diet counselling record’ by individual. The title of developed ‘Diet counselling record’ was ‘What is the desirable nutrition for myself?’, and was comprised of following items: ‘How is my body composition and BMI?’, ‘The intake and evaluation on nutrients for myself (29 nutrients: calorie, macronutrients, fat-soluble/water-soluble vitamins, macro/micro minerals)’, and ‘Recommended dietary intake (RDI)’.
     Fourth, the feedback & support session provided the participants with rewards (complimentary mobile text and coupons) of positive feedback in cases of accomplishment of individual objectives, by the degree of participation in individual exercises every month.
    Arm 2

    Arm Label

    control group

    Target Number of Participant

    23

    Arm Type

    No intervention

    Arm Description

    The participants in control group were provided with the pamphlet, ‘Healthy menstruation and lifestyle’, which was used in the session of small group education, through online services after completion of pre-test.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N92.6)Irregular menstruation, unspecified 

    Irregular menstruation
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    19Year~27Year

    Description

    The selection criteria were female students who reported irregular menstruation and less than 10 times of menstruation in a year.
    Exclusion Criteria
    Exclusion criteria were female students taking oral contraceptive pills (estrogen, progestin) or other drugs associated with menstrual disorder, or those under pertinent care.
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    MCI, SHBG & Androgenic profile [testosterone (T), free androgen index(FAI)
    Timepoint
    at pre-test, at post-test(after 6 months)
    Secondary Outcome(s) 1
    Outcome
    premenstrual symptoms (PMS), menstrual volume, body composition parameters, glycemic parameters [fasting blood sugar (FBS), insulin, HOMA-IR], sleep duration, perceived stress, and nutrients intake
    Timepoint
    at pre-test, at post-test(after 6 months)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 10
    Way of Sharing Available on Request
    (inhae05@gmail.com)
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