UMIN-CTR Clinical Trial

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