Assessing Exclusive Breastfeeding Practice

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

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.

Study Overview

• Status: Completed
• Conditions: Human Milk; Exclusive Breastfeeding; Breast Milk
• Intervention / Treatment: Other: Deuterium dose-to-mother method for assessing breastfeeding

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 Isotope ratio mass spectrometer (IRMS) or Fourier Transform Infrared Spectroscopy (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.

• Study Type: Observational
• Enrollment (Actual): 206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The participants were mother-baby pairs who were eligible according to the inclusion and exclusion criteria. There were recruited from hospitals, health clinics, or communities.

Description

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 Weight-for-height Z score (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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; 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; Exclusive breastfeeding practice was compared between maternal recall and the deuterium dose-to-mother method.

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
Weight of infants	Body weight in kilograms	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
Body composition of mothers: fat mass	Fat mass in kilograms and as a percentage of body weight	Jan 2016 - Dec 2020
length of infants	Body length in centimeters. Weight-for-age, length-for-age, and weight-for-length z-scores were calculated based on the World Health Organization (WHO) growth standard.	Jan 2016 - Dec 2020

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; International Atomic Energy Agency; National Institute of Health Research and Development, Ministry of Health Republic of Indonesia; National University of Malaysia; St. John's Research Institute; National Institute of Nutrition, Vietnam; Pakistan Institute of Nuclear Science and Technology (PINSTECH); Faculty of Medicine, University of Ruhuna, Sri Lanka; Research Organization for Nuclear Energy-BRIN Indonesia; National Center for Maternal and Child Health, Mongolia
• Investigators: Study Director: Tippawan Pongcharoen, PhD, Mahidol U

Publications and helpful links

General Publications

• Tongchom W, Pongcharoen T, Judprasong K, Udomkesmalee E, Kriengsinyos W, Winichagoon P. Human Milk Intake of Thai Breastfed Infants During the First 6 Months Using the Dose-to-Mother Deuterium Dilution Method. Food Nutr Bull. 2020 Sep;41(3):343-354. doi: 10.1177/0379572120943092. Epub 2020 Aug 17.
• Mulol H, Coutsoudis A. Limitations of maternal recall for measuring exclusive breastfeeding rates in South African mothers. Int Breastfeed J. 2018 May 25;13:19. doi: 10.1186/s13006-018-0159-8. eCollection 2018.

Helpful Links

• https://www.iaea.org/publications/8168/stable-isotope-technique-to-assess-intake-of-human-milk-in-breastfed-infants

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RAS6073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No