NCT05063240: MTM-MI

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

Status unknown NA Last updated 5 December 2023

What this trial tests

NA trial testing Mobile phone text messaging plus prospective motivational interviewing in Breastfeeding, Exclusive in 275 participants. Status unknown.

Timeline

22 July 2022

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	University of Stellenbosch
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	275
Start date	22 July 2022
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	1 location across South Africa

Drugs / interventions tested

• Mobile phone text messaging plus prospective motivational interviewing
• Standard infant feeding counselling

Conditions studied

• Breastfeeding, Exclusive — all drugs for Breastfeeding, Exclusive →
• HIV Infections — all drugs for HIV Infections →

Sponsor

University of Stellenbosch

Who can join

18 and older, female only, with Breastfeeding, Exclusive or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Infant feeding: emerging concepts to prevent HIV transmission.
   Bamford A, Foster C, Lyall H. · · 2024 · cited 9× · PMID 37889586 · DOI 10.1097/qco.0000000000000986
2. 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).
   Zunza M, Thabane L, Kuhn L, Els C, et al · · 2023 · cited 1× · PMID 37794523 · DOI 10.1186/s13063-023-07647-9
3. 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.
   Zunza M, Thabane L, Kuhn L, Els C, et al · · 2025 · PMID 39833919 · DOI 10.1186/s13006-024-00693-2
4. 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
   Zunza M, Thabane L, Kuhn L, Els C, et al · · 2024 · DOI 10.21203/rs.3.rs-5132328/v1
5. Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomised controlled trial to evaluate effects on breastfeeding, child health and survival outcomes, among women living with HIV (MTI-MI)
   Zunza M, Thabane L, Kuhn L, Els C, et al · · 2023 · DOI 10.21203/rs.3.rs-3134928/v1