NCT05505760

Brief Summary

The case for mobile health (mHealth) has been gaining traction as a source to improve health outcomes of individuals. mHealth refers to the use of Information and Communication Technologies (ICT) to support health care. The ubiquity and penetration of mobile phones presents the opportunity to deliver health care services directly to citizens, with the greatest potential gains in under-resourced health ecosystems. Operating for 8 years and currently supporting 1.28 million mothers through their pregnancies and early childhood care, MomConnect represents one of the largest maternal health messaging platforms in the world. Implemented at the national level, MomConnect has been credited with being the first national-scale mHealth program of its kind and has won numerous international awards. As a WhatsApp-delivered service, MomConnect has been limited by WhatsApp's historical terms of service. In its current form, MomConnect can only start a conversation with mothers once a week by alerting them of their upcoming antenatal care (ANC) appointment. Recent changes to WhatsApp's terms of service have removed the restriction around push messages for certain programs, including MomConnect. Messages have historically been restricted to weekly conversation starters and carry only generic administrative reminder-style information. As a result, it is possible that many mothers are failing to engage with the content as much as they could. If mothers were more engaged, it could greatly increase exposure and knowledge of reducing the total number of mothers exposed to critical maternal and infant health content. With the updated terms of service, there is an opportunity to test different ways of engaging mothers. This study proposes to evaluate, through a randomized controlled trial (RCT), the relative effect of three new behaviorally-informed program models on key knowledge of and adoption of healthy behaviors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,867

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

August 16, 2022

Last Update Submit

October 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • ANC visits

    Binary indicator measuring whether women attended at least 8 ANC visits during pregnancy as recommended by the WHO

    Based on phone survey conducted 7 weeks after expected delivery

  • Immunisation coverage

    Binary indicator measuring whether the newborn child received all 6 vaccinations recommended at birth and 6 weeks after birth

    Based on phone survey conducted 7 weeks after expected delivery

Secondary Outcomes (3)

  • Knowledge/Attitude Index

    Based on phone survey conducted 7 weeks after expected delivery

  • Behaviour Index

    Based on phone survey conducted 7 weeks after expected delivery

  • User Experience

    Backend data is collected throughout users' usage of the platform; survey data based on phone survey conducted 7 weeks after expected delivery

Study Arms (4)

Appointment Reminder Model

EXPERIMENTAL

This is the current MomConnect WhatsApp model (control). Mothers receive weekly conversation starter messages reminding them about their upcoming clinic appointments, providing more comprehensive and relevant maternal health information only after mothers respond to the appointment reminder.

Behavioral: Quality-Based Digital Messaging

Relevant Content Model (WhatsApp)

EXPERIMENTAL

Mothers receive weekly conversation starter messages on WhatsApp, which carry both clinic appointment reminders along with some maternal and infant health information relevant to their pregnancy/postpartum stage. In addition, a list of "frequently asked questions" (FAQs) relevant to the week of pregnancy the mother is in are provided so that mothers can engage further with maternal health information topics relevant to them.

Behavioral: Quality-Based Digital Messaging

Relevant Content Model (SMS)

EXPERIMENTAL

Mothers receive twice weekly conversation starter messages of 160 characters each per SMS, which carry both clinic appointment reminders as well as maternal and infant health information, relevant to their stage of pregnancy or the age of their baby. Mothers can access the list of frequently asked questions relevant to their week of pregnancy via USSD.

Behavioral: Quality-Based Digital Messaging

Relevant Content + Browsable Content Model

EXPERIMENTAL

This is a combination of the Relevant Content and Browsable Content Models on WhatsApp (RCM+BCM), including appointment reminders, clinical information, a browsable menu and prompts to relevant stage-based topics. Mothers receive weekly conversation starter messages.

Behavioral: Quality-Based Digital Messaging

Interventions

The impact of MomConnect's models will be evaluated using a randomized controlled trial (RCT). Randomization will be at the individual level, where an individual refers to the "unique user", which is defined by the unique phone number used at the time of registration to MomConnect at health facilities. Randomizing control and treatment allocations ensures that the study groups will be comparable in terms of observable and unobservable characteristics in expectation. Therefore, statistical inference can shed light on the likelihood that any differences in outcome variables at the end of the intervention were caused by the intervention as compared to chance. We will also study the treatment effects on different outcomes between the different arms of the experiment - comparing outcomes across different treatment arms or outcomes in the control to outcomes in treatment arms will help us answer the aforementioned research questions.

Appointment Reminder ModelRelevant Content + Browsable Content ModelRelevant Content Model (SMS)Relevant Content Model (WhatsApp)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women above the age of 18 signing up for MomConnect when being between 16-30 weeks pregnant

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reach Digital Health (formerly Praekelt.org)

Cape Town, South Africa

RECRUITING

MeSH Terms

Conditions

Breast FeedingHematologic Diseases

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorHemic and Lymphatic Diseases

Central Study Contacts

Philipp M Kastrau, PhD

CONTACT

Crystal H Huang, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Economist

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

May 30, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations