UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000046636
Receipt No. 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

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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
Obsterics 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
Email 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
Email lenylatifah1@gmail.com

Sponsor
Institute Postgraduate Program of Semarang Health Polytechnic, Ministry of Health, Indonesia





Postgraduate Program of Midwivery
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053200

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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