Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through m-Health

Malnutrition, Child Clinical Trial

Official title:

Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through m-Health: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05590351
• Other study ID #: 2022-3424-20757
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: August 2025

Study information

• Verified date: October 2022
• Source: Aga Khan University
• Contact: Rozina Nuruddin, PhD
• Phone: +923331288584
• Email: rozina.nuruddin[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 258
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Infant Nutrition Disorders
• Malnutrition
• Malnutrition, Child
• Malnutrition, Infant

Intervention

Behavioral:
• First diet: m-health coaching application
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 counselling
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

Locations

Country	Name	City	State
Pakistan	The Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

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). pii: E1689. doi: 10.3390/ijerph16101689. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Initiation of Breastfeeding (EIBF)	EIBF is defined as the proportion of children put to the breast within one hour of birth	1 year
Primary	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
Primary	Introduction of solid, semi-solid or soft foods	Introduction of 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
Primary	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	1 year
Primary	Meal frequency	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	1 year
Primary	Minimum acceptable diet	Minimum acceptable diet is a composite variable and would be based on meal frequency and dietary diversity.	1 year
Primary	Mean Duration of BF	Mean Duration of BF defined as average duration an infant is breastfed for 12 months.	1 year
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 Year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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	1 year
Secondary	Severe stunting	Children who are below minus three standard deviations (-3 SD) are considered severely stunted	1 year
Secondary	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	1 year
Secondary	Severely wasted	Children whose weight-for-height Z-score is below minus three standards deviations (-3 SD) from the median of the reference population are considered severely wasted	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Severely underweight	Children whose weight-for-age Z-score is below minus three standards deviations (-3 SD) from the median are considered severely underweight.	1 year

External Links

•   National Nutrition Survey 2018 - Key Findings Report. (2018)
•   Newborns: improving survival and well-being. (2020)
•   Only 15pc children in Pakistan receiving minimum acceptable diet
•   The World Health Organization's infant feeding recommendation," World Health Organization
•   WHO.int. 2020. Infant And Young Child Feeding