UMIN-CTR 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

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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

Email

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/

Email

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

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

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/ctr_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