Clinical trial NCT05590351: Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through M-Health
Official title: Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through M-Health: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition, Infant
Malnutrition, Child
Keywords: infant & young child feeding practices
stunting
wasting
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 258
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: m-health coaching application
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Women who do not possess smart phone.
2. Women who plan to move to different location after delivery.
3. Women with complicated pregnancy that might require referral by the end of pregnancy

Primary outcomes:
measure: Early Initiation of Breastfeeding (EIBF)
timeFrame: 1 year
measure: Exclusive Breast Feeding (EBF)
timeFrame: 1 year
measure: Introduction of solid, semi-solid or soft foods
timeFrame: 1 year
measure: Minimum dietary diversity
timeFrame: 1 year
measure: Meal frequency
timeFrame: 1 year
measure: Minimum acceptable diet
timeFrame: 1 year
measure: Mean Duration of BF
timeFrame: 1 year
measure: Continued BF at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Acute respiratory Infection (ARI)
timeFrame: 1 year
measure: Acute Diarrhea
timeFrame: 1 Year
measure: Visit to the Emergency room
timeFrame: 1 year
measure: Hospitalization
timeFrame: 1 year
measure: Stunting (height-for-age)
timeFrame: 1 year
measure: Wasting (weight-for-height)
timeFrame: 1 year
measure: Overweight (weight-for-height)
timeFrame: 1 year
measure: Underweight (weight-for-age)
timeFrame: 1 year
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
Study officials:
affiliation: Agha Khan University
name: Rozina Nuruddin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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