UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063455 |
|---|---|
| Receipt number | R000071901 |
| Scientific Title | Effects of a Husband-Involved mHealth Intervention on Postpartum Depressive Symptoms, Anxiety, and Mother-Infant Bonding Among Postpartum Women in Rural Bangladesh: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/29 10:28:11 |
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Basic information
Public title
Impact of mHealth Intervention on Postpartum Depressive Symptom, Anxiety, and Maternal-Infant Bonding Among the Postpartum Women in Rural Community of Bangladesh: A Randomized Controlled Trial
Acronym
Husband-Involved Postpartum mHealth Study
Scientific Title
Effects of a Husband-Involved mHealth Intervention on Postpartum Depressive Symptoms, Anxiety, and Mother-Infant Bonding Among Postpartum Women in Rural Bangladesh: A Randomized Controlled Trial
Scientific Title:Acronym
SMART-MAMA-BG Trial
Region
| Asia(except Japan) |
Condition
Condition
Postpartum depressive symptoms
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of an mHealth intervention with husband involvement on reducing postpartum depressive symptoms and anxiety and improving mother-infant bonding among postpartum women in rural Bangladesh, to evaluate women's knowledge, attitudes, and practices regarding infant positioning and attachment during breastfeeding, and to explore postpartum women's and husbands' experiences and perceptions of the mHealth intervention and barriers and facilitators affecting postpartum mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in postpartum depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS) from baseline to the end of the 12-week intervention.
Key secondary outcomes
1. Change in anxiety measured by the State-Trait Anxiety Inventory (STAI) from baseline to the end of the 12-week intervention.
2. Change in mother-infant bonding measured by the Mother and Infant Bonding Score (MIBS) from baseline to the end of the 12-week intervention.
3. Change in women's knowledge, attitudes, and practices (KAP) regarding infant positioning and attachment during breastfeeding from baseline to the end of the 12-week intervention.
4. Postpartum women's and husbands' experiences and perceptions of the mHealth intervention and barriers and facilitators affecting postpartum mental health.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to routine postnatal care, participants in the intervention group will receive a 12-week mHealth education intervention using a mobile application. The intervention includes physical support (stretching and pelvic floor muscle training), psychological support (muscle relaxation and breathing techniques), and education on postpartum depression, self-care, mother-infant bonding, breastfeeding, and infant positioning and attachment during breastfeeding. Daily push notifications will be provided, and application use and learning progress will be recorded. Husbands will receive orientation and counseling and will be encouraged to provide psychological and practical support, participate in household and childcare activities, and support the women's use of the application.
Interventions/Control_2
Participants in the control group will receive routine postnatal care in accordance with the national guidelines of Bangladesh. No additional mHealth education intervention will be provided during the study period. After completion of the endline assessment, health education materials will be provided to the control group.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Postpartum women aged 18 years or older, either primiparous or multiparous, who delivered at full term.
2. Within 4 weeks postpartum at the time of study enrollment.
3. Residing in the study area for at least 6 months.
4. Able to use a smartphone or having regular access to an internet-enabled smartphone.
5. Willing to participate voluntarily and able to provide written informed consent.
6. Having mild (EPDS score 10-12) or moderate (EPDS score 13-18) depressive symptoms as assessed using the Edinburgh Postnatal Depression Scale (EPDS).
7. Living with their husband.
Key exclusion criteria
1. Participants with no postpartum depressive symptoms (EPDS score <10) or severe postpartum depressive symptoms (EPDS score >18).
2. Participants with a previous diagnosis of a mental disorder, such as psychosis or bipolar disorder.
3. Participants with serious health problems, such as chronic diseases.
4. Participants with disabilities or autism, or those who delivered a newborn with an apparent congenital anomaly.
5. Participants who may move out of the study area during the study period.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimpuku |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences Program of Health Sciences
Zip code
734-8553
Address
1 Chome-2-3 Kasumi, Minami Ward, Hiroshima, Japan
TEL
082-257-5555
yokoshim@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Bilkis |
| Middle name | |
| Last name | Banu |
Organization
Independent University, Bangladesh
Division name
Department of Public Health, School of Pharmacy and Public Health
Zip code
1245
Address
Plot 16, Block B, Aftabuddin Ahmed Road, Bashundhara Residential Area, Bangladesh
TEL
8801716245245
Homepage URL
bilkis@iub.edu.bd
Sponsor or person
Institute
Independent University, Bangladesh
Institute
Department
Personal name
Bilkis Banu
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
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
| 2026 | Year | 10 | Month | 29 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071901
