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
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
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 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
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
1. Source of Monetary/Material Support | |
---|---|
Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | No. NRF- 2017R1D1A1B |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Korea University |
Organization Type | University |
7. Study Summary
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 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
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)
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
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
---|---|
Time of Sharing | 2022. 10 |
Way of Sharing | Available on Request
(inhae05@gmail.com) |
TOP
BOTTOM
화면 최하단으로 이동