UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046472 |
|---|---|
| Receipt number | R000053008 |
| Scientific Title | The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial |
| Date of disclosure of the study information | 2022/01/19 |
| Last modified on | 2022/12/26 18:57:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Acronym
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Scientific Title
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Scientific Title:Acronym
The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Region
| Africa |
Condition
Condition
Financial savings, maternal Health Service Utilization
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of a behavioral intervention designed to encourage financial savings for healthcare costs among pregnant women and their partners in Uganda. To examine whether increased earmarked financial savings for healthcare costs leads to increased utilization of maternal health services and male involvement in maternal healthcare.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is usage of maternal health services, assessed by antenatal care attendance (ANC), skilled birth attendance, and birth at a health facility, as well as the amount of validated expenditure in participants' clinicPesa accounts from the day of enrollment during the intervention period.
Key secondary outcomes
Secondary outcomes include male involvement in maternal healthcare, measured by financial support, attendance to ANC, assisting with planning the delivery, and providing perceived emotional support to the mother, as well as total savings for healthcare, assessed using the validated amount of savings accrued in participants' clinicPesa accounts from the day of enrollment plus any withdrawals for healthcare expenditures during the intervention period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention was formulated using behavioral science approaches for promoting health savings towards the costs of maternal health care among pregnant women and their partners. The intervention consists of a basic mobile money health savings account offered by clinicPesa and additional behavioral designs to encourage savings for maternal health costs. In the intervention group, participants receive the standard clinicPesa offering in addition to behavioral designs that encourage saving. The intervention group will also have fun designs that encourage savings, such as gold coin "rewards," an animated smiling baby character, and other designs to help them keep track of savings targets, such as reminder SMS messages that sound like they are from their child. In the control group, participants receive the standard clinicPesa offering (a mobile money savings account with interest and basic SMS reminders). Both groups will have access to a smartphone application that has a mobile money health savings account as offered by clinicPesa with the ability to deposit and withdraw health savings or set targets.
Interventions/Control_2
The intervention was formulated using behavioral science approaches for promoting health savings towards the costs of maternal health care among pregnant women and their partners. The intervention consists of a basic mobile money health savings account offered by clinicPesa and additional behavioral designs to encourage savings for maternal health costs. In the intervention group, participants receive the standard clinicPesa offering in addition to behavioral designs that encourage saving. The intervention group will also have fun designs that encourage savings, such as gold coin "rewards," an animated smiling baby character, and other designs to help them keep track of savings targets, such as reminder SMS messages that sound like they are from their child. In the control group, participants receive the standard clinicPesa offering (a mobile money savings account with interest and basic SMS reminders). Both groups will have access to a smartphone application that has a mobile money health savings account as offered by clinicPesa with the ability to deposit and withdraw health savings or set targets.
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
| 18 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
To be eligible for joining in this study, participants should have the following characteristics: 18-49 years old, between 12-32 gestational weeks (pregnant female) OR partner of someone who is (male), own a smartphone with internet connection, has a registered mobile money account, willingness to enroll in clinicPesa. Women who are between 12-32 gestational weeks inclusive can partake in the study. Men will partake in the study if their female partner is between 12-32 gestational weeks inclusive at the time of enrollment into the study.
Key exclusion criteria
Participants are ineligible if their partner is known to already be participating in the study to avoid duplicating results of savings amounts; only one member per household may participate in the study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Lisa |
| Middle name | |
| Last name | Hartwig |
Organization
The University of Tokyo
Division name
Department of Community and Global Health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
81-3-3812-2111
lisahartwig@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Lisa |
| Middle name | |
| Last name | Hartwig |
Organization
The University of Tokyo
Division name
Department of Community and Global Health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
81-3-3812-2111
Homepage URL
http://www.ich.m.u-tokyo.ac.jp/en/
lisahartwig@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo, Graduate School of Medicine, Department of Community and Global Health
Institute
Department
Personal name
Funding Source
Organization
Murata Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
clinicPesa, Ltd Uganda
Name of secondary funder(s)
The University of Tokyo
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
81-3-3812-2111
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
The University of Tokyo
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 19 | 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
700
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
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053008
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
