Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through m-Health
Primary Purpose
Malnutrition, Infant, Malnutrition, Child
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
First diet: m-health coaching application
Face to Face counselling
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition, Infant focused on measuring infant & young child feeding practices, stunting, wasting
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women who do not possess smart phone.
- Women who plan to move to different location after delivery.
- Women with complicated pregnancy that might require referral by the end of pregnancy
Sites / Locations
- The Aga Khan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Standard of care
Arm Description
m-health coaching application
Face to face counselling
Outcomes
Primary Outcome Measures
Early Initiation of Breastfeeding (EIBF)
EIBF is defined as the proportion of children put to the breast within one hour of birth
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
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.
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
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
Minimum acceptable diet
Minimum acceptable diet is a composite variable and would be based on meal frequency and dietary diversity.
Mean Duration of BF
Mean Duration of BF defined as average duration an infant is breastfed for 12 months.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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
Severe stunting
Children who are below minus three standard deviations (-3 SD) are considered severely stunted
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
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
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.
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.
Severely underweight
Children whose weight-for-age Z-score is below minus three standards deviations (-3 SD) from the median are considered severely underweight.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05590351
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Infant, Malnutrition, Child
Keywords
infant & young child feeding practices, stunting, wasting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
m-health coaching application
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
m-health coaching application
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Face to face counselling
Intervention Type
Behavioral
Intervention Name(s)
First diet: m-health coaching application
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Face to Face counselling
Intervention Description
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
Primary Outcome Measure Information:
Title
Early Initiation of Breastfeeding (EIBF)
Description
EIBF is defined as the proportion of children put to the breast within one hour of birth
Time Frame
1 year
Title
Exclusive Breast Feeding (EBF)
Description
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
Time Frame
1 year
Title
Introduction of solid, semi-solid or soft foods
Description
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.
Time Frame
1 year
Title
Minimum dietary diversity
Description
Minimum dietary diversity is defined as the proportion of children 6-12 months of age who receive food from 4 or more food groups
Time Frame
1 year
Title
Meal frequency
Description
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
Time Frame
1 year
Title
Minimum acceptable diet
Description
Minimum acceptable diet is a composite variable and would be based on meal frequency and dietary diversity.
Time Frame
1 year
Title
Mean Duration of BF
Description
Mean Duration of BF defined as average duration an infant is breastfed for 12 months.
Time Frame
1 year
Title
Continued BF at 1 year
Description
Continued BF at 1 year defined as the proportion of children 12 months of age who are still on breast milk.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acute respiratory Infection (ARI)
Description
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.
Time Frame
1 year
Title
Acute Diarrhea
Description
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.
Time Frame
1 Year
Title
Visit to the Emergency room
Description
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.
Time Frame
1 year
Title
Hospitalization
Description
Hospitalization will be defined as the infant admitted to the hospital for diagnosis or management of any acute illness in the past 2 weeks.
Time Frame
1 year
Title
Stunting (height-for-age)
Description
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
Time Frame
1 year
Title
Severe stunting
Description
Children who are below minus three standard deviations (-3 SD) are considered severely stunted
Time Frame
1 year
Title
Wasting (weight-for-height)
Description
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
Time Frame
1 year
Title
Severely wasted
Description
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
Time Frame
1 year
Title
Overweight (weight-for-height)
Description
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.
Time Frame
1 year
Title
Underweight (weight-for-age)
Description
Children whose weight-for-age Z-score is below (-2 SD) from the median of the reference population are classified as underweight.
Time Frame
1 year
Title
Severely underweight
Description
Children whose weight-for-age Z-score is below minus three standards deviations (-3 SD) from the median are considered severely underweight.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Women who do not possess smart phone.
Women who plan to move to different location after delivery.
Women with complicated pregnancy that might require referral by the end of pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rozina Nuruddin, PhD
Phone
+923331288584
Email
rozina.nuruddin@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rozina Nuruddin, PhD
Email
rozina.nuruddin@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rozina Nuruddin, PhD
Organizational Affiliation
Agha Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
33323127
Citation
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.
Results Reference
background
PubMed Identifier
15218331
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. doi: 10.1159/000078402.
Results Reference
background
PubMed Identifier
29374000
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.
Results Reference
background
PubMed Identifier
31091768
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):1689. doi: 10.3390/ijerph16101689.
Results Reference
background
Links:
URL
https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding
Description
WHO.int. 2020. Infant And Young Child Feeding
URL
https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding
Description
The World Health Organization's infant feeding recommendation," World Health Organization
URL
https://www.unicef.org/pakistan/reports/national-nutrition-survey-2018-key-findings-report
Description
National Nutrition Survey 2018 - Key Findings Report. (2018)
URL
https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality
Description
Newborns: improving survival and well-being. (2020)
URL
https://www.thenews.com.pk/print/368185-only-15pc-children-in-pakistan-receiving-minimum-acceptable-diet
Description
Only 15pc children in Pakistan receiving minimum acceptable diet
Learn more about this trial
Promotion of Exclusive Breast Feeding and Young Child Feeding Practices Through m-Health
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