Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health Outcomes (MTM-MI)

December 4, 2023 updated by: Moleen Zunza, University of Stellenbosch

Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health and Survival Outcomes, a Group Sequential Randomised Standard of Care Controlled Trial

Background

Lack of breastfeeding, at a minimum, doubles the risk of infant death in the first six months of life. Many infants in low resourced settings at high risk of infectious disease morbidity and death are deprived of the immunological and nutritional benefits of breast milk, through an attenuated duration of breast milk exposure. South Africa has one of the lowest exclusive breastfeeding rates in Africa, 8% in infants under 6 months of age. Mobile phone text messaging as a simple, low-cost intervention improves medication adherence among patients with HIV, diabetes and tuberculosis. Motivational interviewing has been beneficial across many health problems, including HIV viral load suppression, body weight loss, and alcohol and tobacco use. Combining a number of intervention approaches is more likely to influence behaviour change than an individual approach. Investigators assume that continued breastfeeding is sustained among women living with HIV receiving weekly text messages combined with motivational interviewing and that this contributes to improved infant health outcomes.

Objectives:

  1. To determine the effects of mobile phone text messaging combined with motivational interviewing versus standard of care on: (a) Continued exclusive breastfeeding to six month of child age, (b) Continued any form of breastfeeding to 6 month of child age.
  2. To determine the contribution of the combined intervention on improved infant health outcomes: (a) Infant morbidity (all -cause hospitalization) and death (all -causes, (b) Infant growth.

Methods

Investigators propose a group sequential clinical trial to determine whether text messaging combined with motivational interviewing will prolong breastfeeding and the contribution of the combined intervention on improved infant health outcomes. The study will recruit 275 women living with HIV and HIV exposed infants at birth and randomly assign study interventions for 6 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.

Detailed Description

Background

In 2010, following changes to global HIV and infant feeding guidelines, the South African vertical transmission prevention program stopped provision of formula milk and adopted breastfeeding as the recommended infant feeding modality. However, in reality, there are short-falls in attaining optimal infant feeding practices, which are contributing to failure to achieving the Sustainable Development under-five child health targets in South Africa. It is essential for the well-being of women living with HIV and their infants to establish models for supporting optimal infant feeding practices to achieve the desired child health outcomes.

Despite several proven interventions to improve breastfeeding practices, in practice there is lack of progress in implementing these interventions to achieve optimal breastfeeding practices. Telephonic support and motivational interviewing have been beneficial across many health problems, including medication adherence among people living with HIV and to reduce alcohol and tobacco use. Investigators propose to combine telephonic support with motivational interviewing to support infant feeding among women living with HIV. Combining these two interventions has great potential; it is likely to be cost-effective, simple to implement and easily integrated within the established infant feeding counselling conventional models.

Objectives

  1. To determine the effects of mobile phone text messaging plus motivational interviewing versus standard of care on: (a) Continued exclusive breastfeeding to six month of child age, (b) Continued any form of breastfeeding to 6 month of child age.
  2. To determine the contribution of the combined intervention on improved infant health outcomes: (a) Infant morbidity (all -cause hospitalization) and all -cause death, (b) Infant growth.

Methods

Study design: Participants will be randomized in a 1:1 ratio using a permuted block method to receive study interventions versus standard of care for 24 weeks. Electronic sequence generation and random allocation will be done centrally. Participants meeting inclusion criteria who consent to participate will be enrolled and immediately assigned to a study arm sequentially.

Study interventions: All women and their infants, irrespective of study assignments, will receive health services and treatment according to the respective provincial guidelines applicable in the sector during the study. Participants will be evaluated soon after giving birth and post-delivery until cessation of breastfeeding or until end of the study.

Mobile phone text messaging: Every Monday morning, a research nurse will send text message to women in the intervention group encouraging mothers to exclusively breastfeed and inquire if mothers have any problems breastfeeding infants. Participants will be asked to respond by text within 48 hours, indicating no problem or a problem with breastfeeding and require help. The research nurse will review all the responses and then follow-up any participants who indicate a breastfeeding problem or call participants who fail to respond within 48 hours.

Motivational interviewing: In addition to text messaging, women will have individual motivational interviews post-delivery at weeks 2, 6, and 10. During the interviews, the research nurse will have to understand participant's frame of reference, reinforce participant's own self-motivational statements, monitor the readiness to change, and affirm the participant's freedom of choice. Advice will be given with participant's permission, and when given, the participant will make her own choice.

Usual standard of care: Participants randomized to the usual standard of care group will be counselled by primary healthcare nurses and trained lay counsellors to exclusively breastfeed for the first six months. Participants will be free to call the clinic staff at any time.

Sampling plan, recruitment, study assessment and follow-up: Pregnant women living with HIV and giving birth at a healthcare facility in Cape Town, South Africa, between October 2021 and September 2023 will be informed about the study and mothers who indicate interest in participating will be consented for the study. Informed consent will be requested to conduct an enrolment maternal interview, four in-person follow-up visits, child hospitalization medical record review, and child height and weight measurements.

Participants will have in-person follow-up at weeks 2, 6, 10, and 24 of child age. Research nurses or counselors will administer a baseline questionnaire and follow up study questionnaires.

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.
275

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

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Khayelitsha District Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women living with HIV and HIV exposed infants
  • initiating breastfeeding soon after delivery
  • 18 years and older
  • ownership of a mobile phone
  • infant judged to be in good health who are discharged soon after delivery

Exclusion Criteria:

  • initiating formula feeding soon after delivery
  • multiple birth deliveries
  • birthweight <2500
  • gestational age <36 weeks

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Mobile phone text messaging plus prospective motivational interviewing
Experimental: Text messaging-motivational interviewing. Every Monday morning, a text message (SMS) will be sent to participants in the intervention group encouraging participants to continue breastfeeding, and inquire if participants have any problems breastfeeding the infants. Participants will be asked to respond within 48 hours, indicating no problem or a problem with breastfeeding that requires help. In addition to text messaging, participants will have motivational interviews post-delivery at weeks 2, 6, and 10. Motivational interviews will explore and support the participant's commitment to continue breastfeeding.
Behavioral: Mobile phone text messaging plus prospective motivational interviewing
Interactive weekly mobile phone text messaging plus prospective motivational interviewing at study follow up visits
Behavioral: Standard infant feeding counselling
Standard infant feeding counselling as part of routine practice at primary healthcare facility
Active Comparator: Standard infant feeding counselling
Standard infant feeding counselling as part of routine primary healthcare practice
Behavioral: Standard infant feeding counselling
Standard infant feeding counselling as part of routine practice at primary healthcare facility

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
Number of participants who are exclusively breastfeeding
Time Frame: from birth to 6 month of child age
Number of participants who report giving only breast milk and no other liquid or solid based foods to infants as assessed by the infant feeding questionnaire
from birth to 6 month of child age
Number of participants who are practicing any form of breastfeeding
Time Frame: from birth to 6 months of child age
Number of participants who report giving breast milk and other liquid or solid based foods to infants as assessed by the infant feeding questionnaire
from birth to 6 months of child age

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
Infant morbidity
Time Frame: from birth to 6 months of child age
All -cause hospitalization and all -cause death
from birth to 6 months of child age
Infant weight in kilograms
Time Frame: from birth to 6 months of child age
Infant weight measurements
from birth to 6 months of child age
Infant length in centimetres
Time Frame: from birth to 6 months of child age
Infant length measurements
from birth to 6 months of child age

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.
University of Stellenbosch

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.
Columbia University
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moleen Dzikiti, University of Stellenbosch
  • Study Chair: Mark Cotton, University of Stellenbosch
  • Study Chair: Louise Kuhn, Columbia University
  • Study Chair: Taryn Young, University of Stellenbosch
  • Study Chair: Lehana Thabane, McMaster University

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.
July 22, 2022

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.
September 30, 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.
September 30, 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, 2021

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.
September 21, 2021

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.
October 1, 2021

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.
December 5, 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.
December 4, 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.
December 1, 2023

More Information

Terms related to this study

Keywords

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.
  • M21/03/010
  • TMA2020CDF-3169 (Other Grant/Funding Number: EDCTP2 supported by European Union and Fondation Botnar)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data will be available on SUNScholarData, an institutional research data repository that is managed by Stellenbosch University library. Participant's anonymized and de-identified data will added to the public data repository.

IPD Sharing Time Frame

Data will become available within 6 months of completing study follow up. Data will be available for 15 years.

IPD Sharing Access Criteria

Researchers working on similar maternal-child health related studies with appropriate institutional review board approvals for any additional pooled analyses

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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