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Malnutrition, InfantNCT05590351

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

A study testing First diet: m-health coaching application and Face to Face counselling in people with Malnutrition, Infant and Malnutrition, Child, run by Aga Khan University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 48 years, women onlyHealthy volunteers can take part
Conditions the study is for
Malnutrition, Infant, Malnutrition, Child
What is being tested?
First diet: m-health coaching application and Face to Face counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 sitePakistan
Study dates
2 Feb 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 48 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rozina Nuruddin, PhD contact

+923331288584

rozina.nuruddin@aku.edu

Rozina Nuruddin, PhD contact

rozina.nuruddin@aku.edu

Pakistan1 site, 1 recruiting
  • The Aga Khan University

    Karachi, Sindh, 74000

    Rozina Nuruddin Associate Professor, PhD, +92 21 3493 0051 ext. 4833, rozina.nuruddin@aku.edu

    Recruiting

Other trials in Pakistan

About this study

Official title: Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan: A Randomized Controlled Trial

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.

Read the detailed description

Every infant has the right to good nutrition. Early life nutrition is the key modifiable determinant of child growth, development, health, survival and chronic diseases of adult onset. The first year of infant's life provides a window of opportunity to improve health through adoption of recommended infant feeding practices. Breast milk is one of the first nutrition sources that a baby must be introduced to for optimum nutrition, health and growth. It is not only an important determinant of the nutritional status of the child but is also beneficial to strengthen the immune system of the baby and their sensory and cognitive development through creation of an intimate bond between the mother and her baby. Breast milk production and its consumption by the baby is also integral for the health of the mother, as it prevents the mother from ovarian and breast cancer and keeps her healthy for future pregnancies.

World Health Organization (WHO), therefore, recommends exclusive breastfeeding for up to 6 months and continued breastfeeding for at least 1 year for babies. Exclusive breast feeding is defined as 'infant receiving only breast milk without any food or drink, including water. Young Child Feeding Practices (YCFP) refers to the optimal feeding practices for a child aged between 6-12 months. This study aims to promote exclusive breastfeeding and young child feeding practices among women residing in the urban setup in the main city of Karachi, Pakistan, by the use of m-health intervention. WHO defines m-health as 'the use of mobile and wireless technologies to support the achievement of health objectives.

Pakistan is the sixth most populous country of the world. It is signatory to global agreement on reduction of under nutrition among children. Although, during the last decade (2011-18), proportion of underweight and stunted children has declined from 32% to 29%, and 44% to 40.2% respectively, proportion of wasting is showing an increasing trend from 15% to 17.7%. Further, the improvement achieved is not substantial. A quarter of newborns are born with low birth weight. Neonatal mortality rate (44.2/1000 live births (LBs) contributes 57% to the under-five mortality rate (74.9/1000 LBs) where breast feeding plays a crucial role for survival.

According to National Nutrition Survey 2018, only 48% of children under the age of 6 months are exclusively breast fed which is a suboptimal rise from 38% during 2012-13. The survey also highlighted that only 45.8% of infants were breastfed within 1 hour of birth. Likewise, only 35.9% of the infants between 6-8 months of age were weaned on age-appropriate complementary feeding, 14.2% receive minimum dietary diversity, 18.2% receive minimum meal frequency and 3.7% receive minimum acceptable diet. However, all these complementary feeding indicators are well below acceptable levels and are on decline compared to National Nutrition Survey 2011 except for dietary diversity. Below acceptable level of IYCF practices are found to be associated with maternal age, maternal illiteracy, unemployment, and poor household wealth status.

Province of Sindh has unsatisfactory infant and child nutritional indicators. Only 48% of mothers practice early initiation of breastfeeding within one hour of delivery while EBF is reported by 52.3% of the mothers. Similarly, only 43.5% of the children receive age-appropriate complementary feeding. Also, IYCF indicators of Sindh are poor compared to the other provinces of Pakistan. The proportions of children with minimum acceptable diet, minimum meal frequency and minimum dietary diversity are only 2.2%, 16.9% and 12.6% respectively and are lower than national estimates.

With the surge of technology use worldwide, the usage of mobile phone is also increasing in Pakistan. As per December 2019, there were 165 million cellular subscribers with 76 million 3G/4G users with smart phone penetration of 35.9% in Pakistan, though the usage is greater among males compared to females. Among women, 20% have access to a smartphone, 6% have a feature device while 23% have a basic mobile phone.

Mobile health (m-Health) has the potential to transform healthcare delivery by providing tailored and repeated information to individuals. Nowadays, a great bulk of the reproductive population has access to internet and socio media. Due to its increasing popularity, it bears the potential for delivery of intervention to a large number of people at a low cost.

However, such intervention has not been tested out in province of Sindh, in an urban setup where this technology use is increasing significantly over time. Hence, this study would be an important step in providing scientifically sound evidence to the limited pool of available literature on the effectiveness of m-Health interventions aimed at health care workers providing maternal and neonatal services in Low Middle Income Countries.

Being tested
First diet: m-health coaching application, Face to Face counselling
Keywords
infant & young child feeding practices, stunting, wasting
Medical subject headings
Infant Nutrition Disorders, Child Nutrition Disorders, Growth Disorders, Cachexia

What participants receive

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

  • First diet: m-health coaching applicationBehavioural

    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

  • Face to Face counsellingBehavioural

    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

Study groups in NCT05590351
Study groupRoleWhat they receive
InterventionExperimentalm-health coaching application
Receives: Behavioral: First diet: m-health coaching application
Standard of careActive comparatorFace to face counselling
Receives: Behavioral: Face to Face counselling

What is being measured

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

  1. 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

    Measured: 1 year

  2. 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.

    Measured: 1 year

Secondary outcomes (14)
  1. Early Initiation of Breastfeeding (EIBF)

    EIBF is defined as the proportion of children put to the breast within one hour of birth

    Measured: 1 year

  2. Continued BF at 1 year

    Continued BF at 1 year defined as the proportion of children 12 months of age who are still on breast milk.

    Measured: 1 year

  3. Mean Duration of BF

    Mean Duration of BF defined as average duration an infant is breastfed for 12 months.

    Measured: 1 year

  4. Minimum Acceptable Diet

    Minimum acceptable diet is a composite variable and would be based on meal frequency and dietary diversity.

    Measured: 1 year

  5. Minimum Meal Frequency

    Minimum Meal Frequency defined as the average number of daily meals for children 6-12 months of age, who receive solid, semi-solid, or soft foods Infant and young child feeding indicator

    Measured: 1 year

  6. Minimum Dietary Diversity

    Minimum dietary diversity is defined as the proportion of children 6-12 months of age who receive food from 4 or more food groups

    Measured: 1 year

  7. Acute Respiratory Infection (ARI)

    Acute respiratory Infection will be defined as short, rapid breathing that is chest-related and/or difficult breathing that is chest-related. Percentage of children up to 1 year of age with symptoms of ARI at any time in the last 2 weeks preceding the follow-up.

    Measured: 1 year

  8. Acute Diarrhea

    Acute Diarrhea will be defined as the passage of three or more loose or liquid stools per day (or more frequent passage than is normal for the individual). The frequent passing of formed stools is not diarrhea, nor is the passing of loose, "pasty" stools by breastfed babies. Percentage of children up to 1 year of age with symptoms of diarrhea at any time in the last 2 weeks preceding the follow-up.

    Measured: 1 Year

  9. Visit to the Emergency room

    Visit to the Emergency room will be defined as the infant brought to the emergency room for management of any acute illness in the past 2 weeks.

    Measured: 1 year

  10. Hospitalization

    Hospitalization will be defined as the infant admitted to the hospital for diagnosis or management of any acute illness in the past 2 weeks.

    Measured: 1 year

  11. Stunting (height-for-age)

    Stunting will be defined as Children whose height-for-age Z-score is below minus two standards deviations (-2 SD) from the median of the reference population

    Measured: 1 year

  12. Wasting (weight-for-height)

    Wasting will be defined as the children whose Z-score is below (-2 SD) from the median of the reference populations are considered thin (wasted), or acutely undernourished

    Measured: 1 year

  13. Overweight (weight-for-height)

    Children whose weight-for-height Z-score is more than 2 standard deviations (+2 SD) above the median of the reference population is considered overweight.

    Measured: 1 year

  14. Underweight (weight-for-age)

    Children whose weight-for-age Z-score is below (-2 SD) from the median of the reference population are classified as underweight.

    Measured: 1 year

Timeline

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

  1. First posted21 Oct 2022
  2. Study start2 Feb 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
m-health coaching application
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590351
Sponsor's protocol ID
2022-3424-20757
Status last verified
Feb 2026
First submitted
12 Oct 2022
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers.

Publications

  • 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.

    PubMed 33323127
  • 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.

    PubMed 15218331
  • 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.

    PubMed 29374000
  • 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.

    PubMed 31091768
  • 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.

    PubMed 24639004
  • 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.

    PubMed 31700614
  • Nuruddin R, Iqbal R, Mohammed N, Vadsaria KBA, Nausheen S, Sayani S, Azam I. Efficacy of a Mobile Health App in Promoting Breastfeeding and Young Child Feeding Practices in Pakistan: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jul 20;15:e93181. doi: 10.2196/93181.

    PubMed 42475251

Questions about this trial

What is this clinical trial studying?

A study testing First diet: m-health coaching application and Face to Face counselling in people with Malnutrition, Infant and Malnutrition, Child, run by Aga Khan University at 1 site in Pakistan.

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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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 Pakistan. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Rozina Nuruddin, PhD (+923331288584, rozina.nuruddin@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exclusive Breast Feeding (EBF) (time frame: 1 year). 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 NCT05590351, which also lists 7 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 12 Feb 2026.

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