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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048566
Receipt No. R000054171
Scientific Title Impact of parenting intervention on child feeding, early stimulation, and father's involvement in childcare in rural Malawi: a cluster randomized controlled trial
Date of disclosure of the study information 2022/08/03
Last modified on 2022/08/03

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Basic information
Public title Impact of parenting intervention on child feeding, early stimulation, and father's involvement in childcare in rural Malawi: a cluster randomized controlled trial
Acronym Impact of parenting intervention on child feeding, early stimulation, and father's involvement in childcare in rural Malawi
Scientific Title Impact of parenting intervention on child feeding, early stimulation, and father's involvement in childcare in rural Malawi: a cluster randomized controlled trial
Scientific Title:Acronym Impact of parenting intervention on child feeding, early stimulation, and father's involvement in childcare in rural Malawi
Region
Africa

Condition
Condition Caregiver with a child aged 6-23 months (mother and father)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of parenting intervention on child feeding, early stimulation, and father's engagement in childcare among caregivers of a child aged 6-23 months in rural Malawi
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Child dietary diversity score
Key secondary outcomes 1. Caregiver early stimulation
2. Father's engagement in childcare
3. Caregiver's infant and young child feeding (IYCF) knowledge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The mothers-only group will participate in the parenting intervention for 8 weeks.
The intervention is designed using Behavior Change Communication (BCC) and positive affect induction.

The parenting intervention consists of:
- Monthly peer-group sessions (2 times): Activities include BCC delivery, storytelling, demonstration, and group discussion.
- Bi-weekly home visits (4 times): Activities include positive counseling and monitoring by the trained facilitators.
- Weekly audio messages (8 times): The reminder on BCC will be sent to the participant's phone.

BCC and all activities focus on the following topics:
- Infant and Young Child Feeding (IYCF)
- Early stimulation & responsive childcare
- Co-parenting
Interventions/Control_2 The fathers-only group will participate in the parenting intervention for 8 weeks.
The intervention is designed using Behavior Change Communication (BCC) and positive affect induction.

The parenting intervention consists of:
- Monthly peer-group sessions (2 times): Activities include BCC delivery, storytelling, demonstration, and group discussion.
- Bi-weekly home visits (4 times): Activities include positive counseling and monitoring by the trained facilitators.
- Weekly audio messages (8 times): The reminder on BCC will be sent to the participant's phone.

BCC and all activities focus on the following topics:
- Infant and Young Child Feeding (IYCF)
- Early stimulation & responsive childcare
- Co-parenting
Interventions/Control_3 The couples group will participate in the parenting intervention for 8 weeks.
The intervention is designed using Behavior Change Communication (BCC) and positive affect induction.

The parenting intervention consists of:
- Monthly peer-group sessions (2 times): Activities include BCC delivery, storytelling, demonstration, and group discussion.
- Bi-weekly home visits (4 times): Activities include positive counseling and monitoring by the trained facilitators.
- Weekly audio messages (8 times): The reminder on BCC will be sent to the participant's phone.

BCC and all activities focus on the following topics:
- Infant and Young Child Feeding (IYCF)
- Early stimulation & responsive childcare
- Co-parenting
Interventions/Control_4 The control group will receive no intervention.
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 Male and Female
Key inclusion criteria - Caregivers (mothers and fathers) aged 18 years old or above
- Household having a child aged 6-23 months
- A child having a mother as a primary caregiver living with a male partner
- Father/ male partner living in a household with mother/child ten months out of the year
Key exclusion criteria Caregivers who do not meet the inclusion criteria.
Target sample size 1424

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Shibanuma
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Community and Global Health
Zip code 113-0033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5841-3698
Email shibanuma@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Suhyoon
Middle name
Last name Choi
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Community and Global Health
Zip code 113-0033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5841-3698
Homepage URL
Email sychoi@m.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization The University of Tokyo, World-leading Innovative Graduate Study Program on Global Leadership for Social Design and Management
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor REHA
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Research Ethics Committee of the Graduate School of Medicine, the University of Tokyo, Japan
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2022 Year 08 Month 03 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2023 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 03 Day
Last modified on
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054171

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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