Testing Content Delivery Models for MomConnect (MQR)

October 25, 2023 updated by: Haijing Huang, IDinsight

Testing the Effectiveness of Quality-Based WhatsApp Messaging on Vaccine Hesitancy and Childhood Immunization in a National Maternal Messaging Program

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8867

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • All others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Appointment Reminder Model
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
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.
Experimental: Relevant Content Model (WhatsApp)
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
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.
Experimental: Relevant Content Model (SMS)
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
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.
Experimental: Relevant Content + Browsable Content Model
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ANC visits
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
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
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge/Attitude Index
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
Includes knowledge of/attitudes towards diet, breastfeeding, and anemia
Based on phone survey conducted 7 weeks after expected delivery
Behaviour Index
Time Frame: Based on phone survey conducted 7 weeks after expected delivery
Includes behaviour related to ante-natal care visits, diet, pregnancy preparedness, breastfeeding, anemia, and child vaccinations
Based on phone survey conducted 7 weeks after expected delivery
User Experience
Time Frame: Backend data is collected throughout users' usage of the platform; survey data based on phone survey conducted 7 weeks after expected delivery
Includes WhatsApp back-end data and survey data on how users interacted with MomConnect platform
Backend data is collected throughout users' usage of the platform; survey data based on phone survey conducted 7 weeks after expected delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IDinsight

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Reach Digital Health (formerly Praekelt.org)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 008 (Other Identifier: Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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