Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding among infants who are exclusively and partially breastfed at 6 months of age in terms of characteristics that are hypothesised to contribute to growth and development of body composition in infancy. The scientific originality lies in the simultaneous sampling of multiple factors that are believed to contribute to growth and development of body composition in infancy, i.e. energy content of breast-milk, metabolism-regulating hormones in breast-milk, infant temperament and appetite. The selection of two predefined study groups, i.e. infants exclusively breastfed until 6 months of age and infants given complementary foods in addition to breast-milk from 3-4 months of age, gives the opportunity to describe, and perhaps up to some point compare, what now is described by the World Health Organization and in official Icelandic infant recommendations as optimal feeding and what studies have suggested is common feeding in many countries. The methods are carefully chosen, i.e. appropriate and non-invasive isotopes and validated questionnaires are used. To our knowledge, no study has reported breast-milk composition in exclusively vs. partially breastfed infants.

Detailed Description
-----------------
At approximately 5 months of age, all infants in Iceland are invited to receive routine care (health checkup, immunization etc.) at the well-baby clinics at the primary health care centers in their neighbourhood. Nurses at well-baby clinics in and around Reykjavik cooperating with the study investigators screen all infants for eligibility according the eligibility criteria. Mothers of eligible infants receive oral and written information about the study and if interested, a written consent is obtained and study investigators are informed about the potential participant. When the infant is around 5.5 months of age, the mother is contacted and a home visit by study investigators scheduled. In the home visit, more detailed information about the study is given and equipment for predose urine samples are given. The date for the first part of the study (day 0) is scheduled. Day -1 and/or day 0: Mothers sample predose urine sample(s): 2x4 ml for group Exclusive Breastfeeding A and 1x2 ml for groups Exclusive Breastfeeding B and Partial Breastfeeding. Day 0 (home visit by investigators): Infant weighed, drinks 2.5 g/kg body weight + 1 g doubly labeled water or 0.7 g deuterium. Mothers sample postdose urine samples: 6x4 ml for group Exclusive Breastfeeding A (days 1, 2, 3, 5, 6, 7) and 2x2 ml for the other groups (days 0+5 hours and day 2). Mothers of infants in groups Exclusive Breastfeeding B and Partial Breastfeeding keep a 3-day weighed food record assessing their infants' diet including breast milk (by test weighing). Day 7 (home visit by investigators): 2x10 ml breast milk samples (fore and hind milk) are obtained, questionnaires answered by mothers: background questionnaire, food frequency questionnaire on mother's habitual diet, the Baby Eating Behaviour Questionnaire (BEBQ) and the Infant Behaviour Questionnaire-Revised (IBQ-R). At 9 months of age mothers keep a 3-day weighed food record assessing the infants' diet including breast milk if the infant is still breastfed (by test weighing). At 12 months of age the primary outcome measure is assessed. Day -1 or day 0: Mothers sample predose urine sample: 1x2 ml. Day 0 (home visit by investigators): Infant weighed, drinks 1.2 g deuterium. Mothers sample postdose urine samples: 2x2 ml (days 0+5 hours and day 2). Mothers keep a 3-day weighed food record assessing their infants' diet including breast milk if the infant is still breastfed (by test weighing). Mothers answer the Child Eating Behaviour Questionnaire (CEBQ).

Official Title
-----------------
Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland

Conditions
-----------------
Adiposity, Body Composition, Beneficial, Growth Acceleration

Intervention / Treatment
-----------------
* Behavioral: Breastfeeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Icelandic mother Singleton birth Gestational age 37-42 weeks Birth weight >2500 g Living in Iceland until 12 months of age Only groups Exclusive Breastfeeding A and Exclusive Breastfeeding B: Exclusively breastfed at 5.5 months of age (≤5 formula feedings and ≤5 water feedings since birth allowed) Only group Partial Breastfeeding: Receiving at least 100 g / 100 ml of complementary foods (formula or solids) at 5.5 months of age Exclusion Criteria: Diseases or defects likely to affect growth or body composition Not breastfed at 5.5 months of age

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 6 Months

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

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exclusive Breastfeeding A<br>Mother/infant pairs with exclusive breastfeeding up to 6 months of age. Secondary outcome measure 2 (Metabolisable energy content of breast milk) measured in this group only. | Behavioral: Breastfeeding<br>* Breastfeeding at 5.5 months of age (exclusive or partial)<br>|
| Exclusive Breastfeeding B<br>Mother/infant pairs with exclusive breastfeeding up to 6 months of age. | Behavioral: Breastfeeding<br>* Breastfeeding at 5.5 months of age (exclusive or partial)<br>|
| Partial Breastfeeding<br>Mother/infant pairs with partial breastfeeding along with complementary foods at 6 months of age. | Behavioral: Breastfeeding<br>* Breastfeeding at 5.5 months of age (exclusive or partial)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body water measured by deuterium oxide | Total body water measured by deuterium oxide and used to determine fat-free mass | 12 months of age of child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolisable energy content of breast milk measured using doubly labelled water | Measured using doubly labelled water (this outcome only measured in group labeled 'Exclusive Breastfeeding A') | 5.5 months of age of child | 
| Weight measured by infant scales | Weight measured by infant scales | 0-12 months of age of child | 
| Length measured by calibrated lengthboards | Length measured by calibrated lengthboards | 0-12 months of age of child | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth, Body Composition, Breast Feeding, Infant, Milk, Human, Nutritional Sciences, Weaning