Assessing Exclusive Breastfeeding Practice

Study Overview
=================
Brief Summary
-----------------
This study was a longitudinal design. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo.

Detailed Description
-----------------
This study is a longitudinal design that aimed to assess exclusive breastfeeding (EBF) practices in Asian countries and to compare the agreement in EBF between maternal recall and the dose-to-mother technique (DTM) technique. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo. The study planned to recruit 30 mother-baby pairs from each participated country. The was carried out in 7 countries in Asia, namely, Indonesia, Malaysia, Mongolia, Pakistan, Sri Lanka, Thailand, and Vietnam. Mothers were approached at child birth, to explain the project objective and obtain written informed consent. A screening questionnaire was administered to obtain the interest to participate in the study. Only mothers who intend to exclusive breastfeeding till 6 mo will be eligible for further information and sample collection. Isotope dosing of mothers and saliva sample collection were done when the baby is at 3 mo ± 1wk, when a questionnaire (validation questionnaire) was administered. A basal saliva sample was collected prior to dosing with deuterium oxide. The isotope dosing of the mother was given and saliva samples were collected (post-dose) on day 1,2,3,4 and days 13,14. The mother-baby pairs were followed up for another sample collection at 6 mo ± 1 wk and all procedures were repeated, including a questionnaire administration, basal sample collection, deuterium oxide dose administration, and post-dose sample collection. Body weight and height/length of mothers and infants were measured. All saliva samples were analyzed by IRMS or FTIR. Quantity of breast milk intake, non milk oral intake (NMOI) and maternal body composition were determined using standard assumption and formulae developed by the International Atomic Energy Agency (IAEA). Children with NMOI ≥ 86.6 g/day were considered as non-EBF using stable isotopic DTM technique. The overall agreement of EBF classification between the recall and DTM techniques is presented using Kappa statistic with 95% confidence interval.

Official Title
-----------------
Validation of Maternal Recall of Exclusive Breastfeeding by the Deuterium Dilution Method: a Study in 7 Asian Countries

Conditions
-----------------
Human Milk, Exclusive Breastfeeding, Breast Milk

Intervention / Treatment
-----------------
* Other: Deuterium dose-to-mother method for assessing breastfeeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother who practice exclusive breastfeeding Age of mother 18 - 40 years Parity: no more than 3 Baby 3 month ± 7 days Nutritional status WHZ > -2 Full term baby (37 - 40 weeks) Exclusion Criteria: Twin or more baby Low birth weight Baby with oedema Mother with fluid retention disease (kidney disease, heart disease, hypothyroidism) Smoking mother Drinking alcohol mother

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>This is an observation study to determine exclusive breastfeeding practice. Mother-child pairs were enrolled at 3 months ± 7d and were followed-up at 6 months ± 7d. Questionnaire was administered. Then, baseline saliva samples were collected and deuterium oxide dose was administered. Then, post-dose saliva samples were collected. | Other: Deuterium dose-to-mother method for assessing breastfeeding<br>* Exclusive breastfedding practice was compared between maternal recall and the deuterium dose-to-mother method.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-milk oral intake | Quantity of non-milk oral intake (g) | Jan 2016 - Dec 2020 | 
| Human milk intake | Quantity of milk intake (g) | Jan 2016 - Dec 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition of mothers: total body water | Total body water in kilograms and as a percentage of body weight | Jan 2016 - Dec 2020 | 
| Body composition of mothers: fat free mass | Fat free mass in kilograms and as a percentage of body weight | Jan 2016 - Dec 2020 | 
| Body composition of mothers: fat mass | Fat fmass in kilograms and as a percentage of body weight | Jan 2016 - Dec 2020 | 
| Weight of infants | Body weight in kilograms | Jan 2016 - Dec 2020 | 
| lenght of infants | Body length in centimeters. Weight-for-age, length-for-age, and weight-for-length z-scores were calculated based on the WHO growth standard. | Jan 2016 - Dec 2020 | 
| Weight of mothers | Body weight in kilograms | Jan 2016 - Dec 2020 | 
| Height of mothers | Height in centimeters. The body mass index (BMI) was calculated by dividing weight in kilograms by height in meters squared. | Jan 2016 - Dec 2020 | 
| Body mass index of mothers | weight in kilograms divided by height in meters squared | Jan 2016 - Dec 2020 | 
| Breastfeeding pattern | Breastfeeding pattern based on questionnaire | Jan 2016 - Dec 2020 |