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

NCT05063240 | Unknown DMC

• 2 other identifiers: M21/03/010TMA2020CDF-3169
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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 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. 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. 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.

Conditions

Breastfeeding, Exclusive; HIV Infections

Keywords

HIV; Infant feeding; mHealth; motivational interviewing; behavioural intervention

Outcome Measures

Primary Outcomes (2)

• 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

  from birth to 6 month of child age

• 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

  from birth to 6 months of child age

Secondary Outcomes (3)

• Infant morbidity

  from birth to 6 months of child age

• Infant weight in kilograms

  from birth to 6 months of child age

• Infant length in centimetres

  from birth to 6 months of child age

Study Arms (2)

Mobile phone text messaging plus prospective motivational interviewing

EXPERIMENTAL

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; Behavioral: Standard infant feeding counselling

Standard infant feeding counselling

ACTIVE COMPARATOR

Standard infant feeding counselling as part of routine primary healthcare practice

Behavioral: Standard infant feeding counselling

Interventions

Mobile phone text messaging plus prospective motivational interviewing BEHAVIORAL

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

Mobile phone text messaging plus prospective motivational interviewing

Standard infant feeding counselling BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Stellenbosch: lead
• McMaster University: collaborator
• Columbia University: collaborator

Study Sites (1)

Khayelitsha District Hospital

Cape Town, Western Cape, South Africa

Location

Related Publications (2)

• 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.

  PMID: 39833919 DERIVED

• 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.

  PMID: 37794523 DERIVED

MeSH Terms

Conditions

Breast Feeding; HIV Infections

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Moleen Dzikiti

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

• Taryn Young

  University of Stellenbosch

  STUDY CHAIR

• Mark Cotton

  University of Stellenbosch

  STUDY CHAIR

• Lehana Thabane

  McMaster University

  STUDY CHAIR

• Louise Kuhn

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 1, 2021
• Study Start: July 22, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available within 6 months of completing study follow up. Data will be available for 15 years.
• Access Criteria: Researchers working on similar maternal-child health related studies with appropriate institutional review board approvals for any additional pooled analyses

Locations

ZA (1)