Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan

NCT05590351 | Recruiting

• 1 other identifier: 2022-3424-20757
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Early life nutrition is the key modifiable determinant of child growth, development, survival and diseases of adult onset. Pakistan ranks highest for neonatal mortality rate (44.2/1000 live births (LBs)) globally. One third of under-five deaths (74.9/1000 LBs) are attributable to high prevalence of stunting (38%), underweight (23%) and wasting (7%), greatly related to feeding practices. Given the low prevalence of exclusively breast fed (EBF) (48%) and use of minimum acceptable diet (13%), mitigation of early life nutritional risk through promotion of EBF and Young Child Feeding Practices (YCFP) provides a critical window of opportunity for intervention. Secondary Care Hospitals (SCH) of the Aga Khan Health Services Pakistan provide essential maternal and child health services for low-middle income population. Babies born at these SCHs are followed up for vaccination, growth-monitoring and other services at the closely affiliated Family Health Centers (FHCs) run by Lady Health Visitors (LHVs). We aim to examine the effectiveness of a locally designed m-Health application for empowering mothers for child nutritional care as a potentially sustainable approach. The first six months of formative research would identify perceptions, barriers and facilitators for EBF and YCFP using self-determination behavioral theory, among multi-parous pregnant mothers enrolled at three SCHs of Karachi. A randomization trial would be conducted during next 18 months among near-term pregnant women who have access to smart-phones. A culturally appropriate mhealth application called first diet would be developed to provide personalized push messages delivered weekly by the LHVs. Non-intervention group will receive face-face nutritional counselling by the research staff at FHC following routine vaccination and growth-monitoring schedule. Mothers would followed-up from one month prior to expected delivery to child's first birthday. We expect 20% improvement in rates of EBF and YCFP with m-Health intervention. If proven effective, m-health would be incorporated in routine child care provision by LHVs.

Conditions

Malnutrition, Infant; Malnutrition, Child

Keywords

infant & young child feeding practices; stunting; wasting

Outcome Measures

Primary Outcomes (2)

• Exclusive Breast Feeding (EBF)

  EBF up to 6 months of age defined as proportion of infants of 0-6 months of age who are fed exclusively with breast milk

  1 year

• Introduction of age appropiate solid, semi-solid or soft foods

  Introduction of age appropiate solid, semi-solid or soft foods defined as the proportion of infants 6-8 months of age who receive solid, semi-solid or soft foods.

  1 year

Secondary Outcomes (14)

• Early Initiation of Breastfeeding (EIBF)

  1 year

• Continued BF at 1 year

  1 year

• Mean Duration of BF

  1 year

• Minimum Acceptable Diet

  1 year

• Minimum Meal Frequency

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

m-health coaching application

Behavioral: First diet: m-health coaching application

Standard of care

ACTIVE COMPARATOR

Face to face counselling

Behavioral: Face to Face counselling

Interventions

First diet: m-health coaching application BEHAVIORAL

Intervention for the study would comprise of a culturally appropriate m-health application called first diet. This application will be developed considering the perceptions, barriers and facilitators identified through formative research. Content of the messages would focus on breastfeeding, its importance and early initiation within one hour of birth, significance of first feed i.e. colostrum, importance of EBF from birth till 6 months, introduction of complementary feeding to 6-8 months old infants and appropriate YCFP. These messages would be drafted in the local preferable language assessed during formative research. The content of the messages would be translated and then back translated to ensure validity. These messages will be short, contextual and tailored according to the women's stage of gestation, delivery and infant's age

Intervention

Face to Face counselling BEHAVIORAL

Women randomly enrolled in the non-interventional group will receive face-face nutritional counseling instead of mobile application. Once enrolled in the group, Research Assistant (RA) will collect relevant details on the baseline questionnaire like intervention group but on a paper-based questionnaire. Women will be given first face-face counseling on the day of enrollment. The counseling sessions will coincide with the routine vaccination and growth monitoring schedule of the infant after women deliver

Standard of care

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: Females as this study require pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women in the third trimester at 36 +/- 1 week of gestation.
• Planned to stay in their respective areas for at least 1 year after delivery
• Planned to get the infant immunized from the respective FHC of the hospitals.
• Have access to smart phones with internet connection.
• Registered and planning to deliver to any of the Secondary Care Hospitals
• Can read and write in local language (English and/or Urdu).
• Consent to participate and remain in the study until 1 year of child age

You may not qualify if:

• High-risk including maternal neurological/heart/ autoimmune/renal disease, preeclampsia, placenta previa, multiple gestations (twins/triplets), fetal structural/genetic anomalies, fetal growth restrictions, and birth trauma/requiring NICU admission.
• Women who plan to move to different location after delivery

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 74000, Pakistan

RECRUITING

Related Publications (6)

• Ariff S, Saddiq K, Khalid J, Sikanderali L, Tariq B, Shaheen F, Nawaz G, Habib A, Soofi SB. Determinants of infant and young complementary feeding practices among children 6-23 months of age in urban Pakistan: a multicenter longitudinal study. BMC Nutr. 2020 Dec 16;6(1):75. doi: 10.1186/s40795-020-00401-3.

  PMID: 33323127 BACKGROUND

• Sesso R, Barreto GP, Neves J, Sawaya AL. Malnutrition is associated with increased blood pressure in childhood. Nephron Clin Pract. 2004;97(2):c61-6. doi: 10.1159/000078402.

  PMID: 15218331 BACKGROUND

• Wang CJ, Chaovalit P, Pongnumkul S. A Breastfeed-Promoting Mobile App Intervention: Usability and Usefulness Study. JMIR Mhealth Uhealth. 2018 Jan 26;6(1):e27. doi: 10.2196/mhealth.8337.

  PMID: 29374000 BACKGROUND

• Noh JW, Kim YM, Akram N, Yoo KB, Cheon J, Lee LJ, Kwon YD, Stekelenburg J. Factors Affecting Breastfeeding Practices in Sindh Province, Pakistan: A Secondary Analysis of Cross-Sectional Survey Data. Int J Environ Res Public Health. 2019 May 14;16(10):1689. doi: 10.3390/ijerph16101689.

  PMID: 31091768 BACKGROUND

• Jiang H, Li M, Wen LM, Hu Q, Yang D, He G, Baur LA, Dibley MJ, Qian X. Effect of short message service on infant feeding practice: findings from a community-based study in Shanghai, China. JAMA Pediatr. 2014 May;168(5):471-8. doi: 10.1001/jamapediatrics.2014.58.

  PMID: 24639004 BACKGROUND

• Akber S, Mahmood H, Fatima R, Wali A, Alam A, Sheraz SY, Yaqoob A, Najmi H, Abbasi S, Mahmood H, Dibley MJ, Hazir T. Effectiveness of a mobile health intervention on infant and young child feeding among children </= 24 months of age in rural Islamabad over six months duration. F1000Res. 2019 Apr 25;8:551. doi: 10.12688/f1000research.17037.3. eCollection 2019.

  PMID: 31700614 BACKGROUND

Related Links

• WHO.int. 2020. Infant And Young Child Feeding
• The World Health Organization's infant feeding recommendation," World Health Organization
• Newborns: improving survival and well-being. (2020)
• Only 15pc children in Pakistan receiving minimum acceptable diet

MeSH Terms

Conditions

Infant Nutrition Disorders; Child Nutrition Disorders; Growth Disorders; Cachexia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Study Officials

• Rozina Nuruddin, PhD

  Agha Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rozina Nuruddin, PhD

CONTACT

+923331288584; rozina.nuruddin@aku.edu

Rozina Nuruddin, PhD

CONTACT

rozina.nuruddin@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: m-health coaching application

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 21, 2022
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)