UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051088 |
|---|---|
| Receipt number | R000058258 |
| Scientific Title | A randomized controlled trial to evaluate the efficacy of intervention involving motivational interviewing and implementation intentions to motivate working mothers to continue exclusive breastfeeding |
| Date of disclosure of the study information | 2023/05/18 |
| Last modified on | 2023/05/17 18:04:37 |
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Basic information
Public title
A randomized controlled trial to evaluate the efficacy of intervention involving motivational interviewing and implementation intentions to motivate working mothers to continue exclusive breastfeeding
Acronym
A randomized controlled trial to evaluate the efficacy of intervention involving motivational interviewing and implementation intentions to motivate working mothers to continue exclusive breastfeeding
Scientific Title
A randomized controlled trial to evaluate the efficacy of intervention involving motivational interviewing and implementation intentions to motivate working mothers to continue exclusive breastfeeding
Scientific Title:Acronym
A randomized controlled trial to evaluate the efficacy of intervention involving motivational interviewing and implementation intentions to motivate working mothers to continue exclusive breastfeeding
Region
| Asia(except Japan) |
Condition
Condition
Breastfeeding
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the relative efficacy of an intervention of motivational interviewing followed by implementation intentions in increasing rate of exclusive breastfeeding at 6 months postpartum among mothers who have full-time employment and will combine breastfeeding and work while return to work.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the proportion of working mothers who return to work and practising exclusive breastfeeding at 6 months postpartum.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Motivational interviewing plus implementation intentions
Interventions/Control_2
Standard of care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Mothers are eligible to participate if they are: (a) Hong Kong Chinese mothers ; (b) at least 18 years old; (c) Cantonese speaking; (d) singleton pregnancy; (e) having full time employment and currently on maternity leave; (f) continuing any breastfeeding at the time of baseline (6 weeks postpartum).
Key exclusion criteria
The exclusion criteria are: (a) mothers and their infants are separated after birth because their infants are admitted to the special care nursery or the neonatal intensive care unit; (b) mothers with major obstetric complications or serious medical problems.
Target sample size
438
Research contact person
Name of lead principal investigator
| 1st name | Yin-kei |
| Middle name | |
| Last name | Lau |
Organization
The Chinese University of Hong Kong
Division name
JC School of Public Health and Primary Care, Faculty of Medicine.
Zip code
Not applicable.
Address
c/o Centre for Health Behaviours Research, JC School of Public Health and Primary Care, The Chinese University of Hong Kong. Prince of Wales Hospital, Shatin, New Territories, Hong Kong.
TEL
85222528724
ykclau@cuhk.edu.hk
Public contact
Name of contact person
| 1st name | Yin-kei |
| Middle name | |
| Last name | Lau |
Organization
CUHK
Division name
JC School of Public Health and Primary Care, Faculty of Medicine.
Zip code
Not applicable.
Address
c/o Centre for Health Behaviours Research, JC School of Public Health and Primary Care, CUHK.
TEL
85222528724
Homepage URL
ykclau@cuhk.edu.hk
Sponsor or person
Institute
JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong.
Institute
Department
Personal name
Funding Source
Organization
Health and Medical Research Fund, Research Fund Secretariat, Health Bureau, The Government of the Hong Kong Special Administrative Region of the People's Republic of China.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Joint CUHK-NTEC Clinical Research Ethics Committee
Address
8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong
Tel
85235053935
crec@cuhk.edu.hk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
623
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058258
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
