UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048566 |
|---|---|
| Receipt number | 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 | 2023/08/04 13:20:35 |
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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
Caregiver early stimulation
Father's engagement in childcare
Key secondary outcomes
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
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
sychoi@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
712
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054171
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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