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Breastfeeding, ExclusiveMTM-MINCT05063240

Mobile Phone Text Messaging Plus Motivational Interviewing: Effects on Breastfeeding, Child Health Outcomes

A study testing Mobile phone text messaging plus prospective motivational interviewing and Standard infant feeding counselling in people with Breastfeeding, Exclusive and HIV Infections, run by University of Stellenbosch at 1 site in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breastfeeding, Exclusive, HIV Infections
What is being tested?
Mobile phone text messaging plus prospective motivational interviewing and Standard infant feeding counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
1 siteSouth Africa
Study dates
22 Jul 2022to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • Khayelitsha District Hospital

    Cape Town, Western Cape

Other trials in South Africa

About this study

Official title: 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.

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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.

Read the 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.

Being tested
Mobile phone text messaging plus prospective motivational interviewing, Standard infant feeding counselling
Keywords
HIV, Infant feeding, mHealth, motivational interviewing, behavioural intervention
Medical subject headings
Breast Feeding, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile phone text messaging plus prospective motivational interviewingBehavioural

    Interactive weekly mobile phone text messaging plus prospective motivational interviewing at study follow up visits

  • Standard infant feeding counsellingBehavioural

    Standard infant feeding counselling as part of routine practice at primary healthcare facility

Study groups in NCT05063240
Study groupRoleWhat they receive
Mobile phone text messaging plus prospective motivational interviewingExperimentalExperimental: 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.
Receives: Behavioral: Mobile phone text messaging plus prospective motivational interviewing; Behavioral: Standard infant feeding counselling
Standard infant feeding counsellingActive comparatorStandard infant feeding counselling as part of routine primary healthcare practice
Receives: Behavioral: Standard infant feeding counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who are exclusively breastfeeding

    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

    Measured: from birth to 6 month of child age

  2. Number of participants who are practicing any form of breastfeeding

    Number of participants who report giving breast milk and other liquid or solid based foods to infants as assessed by the infant feeding questionnaire

    Measured: from birth to 6 months of child age

Secondary outcomes (3)
  1. Infant morbidity

    All -cause hospitalization and all -cause death

    Measured: from birth to 6 months of child age

  2. Infant weight in kilograms

    Infant weight measurements

    Measured: from birth to 6 months of child age

  3. Infant length in centimetres

    Infant length measurements

    Measured: from birth to 6 months of child age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start22 Jul 2022
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05063240
Sponsor's protocol ID
M21/03/010
Other IDs
TMA2020CDF-3169
Acronym
MTM-MI
Status last verified
Dec 2023
First submitted
16 Aug 2021
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Zunza M, Thabane L, Kuhn L, Els C, Lombard C, Cotton MF, Young T. A randomized controlled, trial on effects of mobile phone text messaging in combination with motivational interviewing versus standard infant feeding counselling on breastfeeding and child health outcomes, among women living with HIV. Int Breastfeed J. 2025 Jan 20;20(1):5. doi: 10.1186/s13006-024-00693-2.

    PubMed 39833919
  • Zunza M, Thabane L, Kuhn L, Els C, Cotton MF, Young T. Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI). Trials. 2023 Oct 5;24(1):639. doi: 10.1186/s13063-023-07647-9.

    PubMed 37794523

Questions about this trial

What is this clinical trial studying?

A study testing Mobile phone text messaging plus prospective motivational interviewing and Standard infant feeding counselling in people with Breastfeeding, Exclusive and HIV Infections, run by University of Stellenbosch at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who are exclusively breastfeeding (time frame: from birth to 6 month of child age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05063240, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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