UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046636 |
|---|---|
| Receipt number | R000053200 |
| Scientific Title | SMART BREASTFEEDING EDUCATION WITH HEALTH ACTION PROCESS APPROACH (HAPA) BASED ON M-HEALTH FOR ENHANCING MATERNAL SELF EFFICACY AND MENTAL HEALTH DURING COVID 19 PANDEMIC |
| Date of disclosure of the study information | 2022/01/14 |
| Last modified on | 2022/01/14 16:59:18 |
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Basic information
Public title
SMART BREASTFEEDING EDUCATION WITH M-HEALTH FOR OPTIMIZING MATERNAL MENTAL HEALTH DURING COVID 19 PANDEMIC
Acronym
HAPA SMART BREASTFEEDING EDUCATION DURING COVID 19 PANDEMIC
Scientific Title
SMART BREASTFEEDING EDUCATION WITH HEALTH ACTION PROCESS APPROACH (HAPA) BASED ON M-HEALTH FOR ENHANCING MATERNAL SELF EFFICACY AND MENTAL HEALTH DURING COVID 19 PANDEMIC
Scientific Title:Acronym
HAPA SMART BREASTFEEDING EDUCATION DURING COVID 19 PANDEMIC
Region
| Asia(except Japan) |
Condition
Condition
Postpartum women with mental health problems
Classification by specialty
| Obstetrics and Gynecology | Psychiatry | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing Smart Breastfeeding Education Model based on Health Action Process Approach (HAPA) theoritical framework delivering with M-health during Covid-19 pandemic and analyze its effectiveness for enhancing maternal breastfeeding self efficacy and mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Smart Breastfeeding Education Model based on Health Action Process Approach (HAPA) theoritical framework delivering with M-health during Covid-19 pandemic were developed
Key secondary outcomes
The effectiveness of the Smart Breastfeeding Education Model delivering with M-health: a) to increase breastfeeding self-efficacy b) to reduce mental health problems (depression, anxiety, and stress) in postpartum mothers during Covid-19 pandemic were analyzed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention groups were given a 3 weeks of "Smart Breastfeeding Women" psychoeducational program (e-modul and animated videos) delivered through Whatsap group.
Interventions/Control_2
Control groups were given e-modul of "Smart Breastfeeding Women" without videos delivered through Whatsap 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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
Postpartum mothers day 1-14 at entrance, willing to complete research process, having smartphone, able to access social media, reporting stress/anxiety/depression in mild-moderate level
Key exclusion criteria
Having depression, anxiety, and stress in severe or very severe level (subjects were referred to public health facilities nearby), having babies with special needs or severe illness
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Aninditya |
| Middle name | |
| Last name | Azis |
Organization
Postgraduate Program of Semarang Health Polytechnic, Ministry of Health, Indonesia
Division name
Midwivery
Zip code
50268
Address
Jl. Tirtoagung, Pedalangan, Banyumanik, Semarang, Jawa Tengah, Indonesia
TEL
620247460274
anindityaazis@gmail.com
Public contact
Name of contact person
| 1st name | Leny |
| Middle name | |
| Last name | Latifah |
Organization
National Health Institute of Research and Development, Ministry of Health, Indonesia
Division name
Magelang Unit
Zip code
56553
Address
Jayan, Borobudur, Magelang
TEL
085727180901
Homepage URL
lenylatifah1@gmail.com
Sponsor or person
Institute
Postgraduate Program of Semarang Health Polytechnic, Ministry of Health, Indonesia
Postgraduate Program of Midwivery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Postgraduate Program of Midwivery, Semarang Health Polytechnic, Ministry of Health, Indonesia
Address
Jl. Tirtoagung, Pedalangan, Banyumanik, Semarang, Jawa Tengah, Indonesia
Tel
620247460274
poltekkes-smg@poltekkes-smg.ac.id
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
| 2022 | Year | 01 | Month | 14 | 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
210
Results
a) Smart Breastfeeding Education Model delivering with M-health were developed and validated
b) Breastfeeding self-efficacy increased significantly after intervention
c) Mental health problems in postpartum mothers during Covid-19 pandemic were decreased significantly after intervention
Results date posted
| 2022 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Based on cohort data from 12 Semarang City Health Centers for postpartum mothers in April-May assessed for eligibility (n=700). Have a cellphone with the WhatsApp and ready to participate (n=400). Excluded (n=300), because don't have a cellphone with the WhatsApp application (n=125), WhatsApp number cannot be reached (n=120), declined to participate (n=55). Mental health screening was carried out for postpartum mothers with the categories of depression, anxiety, mild and moderate stress (n=250). Mental health screening was carried out for postpartum mothers with the categories of depression, anxiety, mild and moderate stress (n=250). Withdrew because unable to contact for further interview and intervention (n=40). Received allocated intervention with smart breastfeeding education with animated videos and e-module (n=105). Received allocated intervention with e-module (n=105). Follow up to the final stage up to 21 days of treatment (n=210). Analysed (n=210). No missing data and no loss to followed up.
Adverse events
No adverse events found
Outcome measures
Plan to share IPD
IPD will be share after publication
IPD sharing Plan description
We belief our research gives added values for developing an intervention model to increase the coverage of maternal postnatal health sevice during social restriction in Covid-19 pandemic in Indonesia. Clinical trial number were urgently required for publication. We thank UMIN for fascilitating clinical trial register number. We plan to share IPD as soon as possible, after article based on this research accepted for publication in targeted journal.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 14 | Day |
Other
Other related information
We belief our research gives added values for developing an intervention model to increase the coverage of maternal postnatal health sevice during social restriction in Covid-19 pandemic in Indonesia. Clinical trial number were urgently required for publication. We are in the process of submitting article from this research, as a respon for a call for paper related to midwivery in Covid 19 pandemic. We thank UMIN for fascilitating clinical trial register number. We plan to share IPD of this research as soon as the article based on this research accepted in targeted journal.
Management information
Registered date
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053200
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