Childhood ObesityJRPNCT03634930
Josef Ressel Centre Perinatal Programming
An observational study of Childhood Obesity, run by Moenie van der Kleyn at 1 site in Austria.
Trial summary
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three months of age. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 16 Feb 2017to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: term (37-41 gestational age), singleton healthy babies with normal birth weight (2.5-4.5 kg) from healthy, non-smoking, non-diabetic mothers with a normal pre-pregnancy BMI (18.5-30). Pregnant women, who plan to breastfeed will be selected from a primary care clinic (STGKK Graz) and young non-breastfeeding mothers will be selected at the maternity ward of the university hospital of Graz.
Who may be able to join
- Pregnancy or mother in puerperium
- Delivery of baby at 37+0 to 41+6 gestational age
- Legal age (18 years old), age limit 50 years
- Written consent of test person after having been informed
- BMI ≥ 18.5 kg/m² to < 30 kg/m²
- Negative result of oGTT (oral glucose tolerance test) during pregnancy
Show all 10Show fewer
- Birth weight of baby 2.5-4.5 kg
- Non-smoker since knowledge of pregnancy
- Very good knowledge of German language and Caucasian
- Exclusive breastfeeding or exclusive formula feeding at MR 2 (4th week of life)
Who cannot join
- Birth before 37+0 week of pregnancy (WoP) or after the 41+6 WoP
- Multiple pregnancy
- Children with serious congenital malformations of
- Nervous system
- Mouth, throat, neck
- Circulation system
Show all 23Show fewer
- Respiratory tract
- Gastrointestinal tract
- Urogenital tract
- Chromosomal aberrations
- Diseases or hospitalization or intensive medical care of child during neonatal period
- Hereditary metabolic diseases of child
- Hereditary disorders of fat metabolism (MCHAD: Medium Chain Acyl-CoA Dehydrogenase Deficiency, LCHAD: Long Chain Acyl-CoA Dehydrogenase Deficiency, VLCHAD: Very Long Chain Acyl-CoA Dehydrogenase Deficiency)
- Hereditary disorders of amino acid metabolism (PKU: Phenylketonuria)
- Hereditary disorders of carbohydrate metabolism (Glycogenosis, Galactosemia, Hereditary fructose intolerance, Diabetes mellitus Type 1)
- Drug (tobacco) abuse
- Mental illnesses that have to be treated with medicaments
- Metabolic or autoimmune diseases of mother
- Complications at birth (blood loss > 1000 ml or eclampsia)
- Pre-conceptional diabetes (type 1 or 2)
- Celiac disease and/or wheat protein allergy of mother
- Breast surgery and/or hypomastia
- Mixed feeding at MR 2 (4th week of life)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
FH Joanneum, university of applied sciences
Graz, Styria, 8020
Moenie D van der Kleyn, MPH, ++433165453 ext. 6610, moenie.vanderkleyn@fh-joanneum.at
Erwin Zinser, Prof FH Dr., ++433165453 ext. 8515, erwin.zinser@fh-joanneum.at
About this study
Official title: Josef Ressel Centre for the Investigation of Early Life Metabolic Programming Regarding Dispositions of Obesity
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three months of age. Breastfeeding in the first year of life appears to be protective against obesity development.
Objective: of the "Josef Ressel Centre for Early Life Metabolic Programming of Dispositions of Obesity" is to identify maternal and infant predictors of metabolic risk of obesity. The main considerations of modifiable factors are early infant nutrition, 24-hours-drinking-volume, the velocity of infant weight gain, in relation to infant fat mass and fat free mass, to biomarker and to the nutritional status of the mother. A second focus is put on maternal feeding style, infant eating behaviour and the identification of satiety cues.
Read more
Multi-Study design: a monocentric prospective longitudinal cohort of 100 healthy, non-obese, non-smoking pregnant mothers and their term, normal birthweight, singleton babies. Mothers and exclusively breastfed versus exclusively formula fed children (at 16 weeks) will be examined at 36 weeks of pregnancy, 4 - 8 - 12 and 16 weeks of life, follow-up at 1 and 2 years of life.
Methods: four weighing protocols between 4th and 16th week of life, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph. Macronutrient and energy content of the breast milk will be analysed by MIRIS™.
Well-defined biomarkers of oxidative stress and inflammation, lipid profile, adipokines, insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more. Also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and 2 years.
A semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure.
Read the detailed description
Nutrition related diseases such as obesity are considered as the main health problems in the 21st century. Overweight and obesity are significant risk factors regarding the development of cardiovascular diseases, strokes, diabetes mellitus, and other non-communicable diseases. In the "Josef Ressel Centre for the Investigation of Early Life Metabolic Programming regarding Dispositions of Obesity" possible predictors towards obesity and their relationship to the volume uptake of formula are to be explored multi-dimensionally. During the first part of the project, the volume study, including a total of 66 mother-infant pairs at the 16th week of life, the overfeeding of infants will be investigated. Overfeeding of infants can be regarded in the context of the amount of food consumed, the ingredients, or in the context of satiety perception of babies by their mother. A closer inspection of the drinking volume of breast-fed infants in comparison to formula-fed ones could give an indication of how much and in what frequency infants ingest food and how the drinking volume affects the weight gain and body fat percentage. To do so, applicable anthropometric data will be collected and the measurement of body fat from mothers and infants will be carried out. Additionally, a semi-automatic detection of satiety signals during feeding will be performed. The identification of satiety signs and the reaction of the mother to those signals, in addition with the feeding style, are related to the weight of the infant and its risk of becoming obese later in life. During the second part of the research project, it will be emphasized whether a coherence exists between early infant nutrition and the manifestation of biomarkers of oxidative stress and inflammation. Thus, detailed analyses regarding macro- and micronutrients, adipokines and biomarkers of oxidative stress of mother milk and biological specimen from mothers and infants will be performed Furthermore, the microbiome of the gut of mothers and infants will be investigated. Results from bioanalytical experiments are intended to sup-port the interpretation of results from the volume study to perceive a deep understanding of the metabolic programming phenomenon of infants at the molecular level.
The five main areas of investigation are:
- 24-hours-drinking-volume: Background: beyond the quality of nutrition during neonatal life, also the quantity in terms of overfeeding plays a critical role in the development of obesity. Objective: to derive evidence on the drinking volume of exclusively breastfed versus exclusively formula fed children, applying strictly the WHO definitions of exclusivity. Secondary objective is the integration of body composition and growth velocity, which may contribute to insights on critical time slots for programming overweight. Methods: weighing protocol, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph PeaPod™ and BodPod™ of the company Cosmed™. The macronutrient and energy content of the breast milk will be also analyzed by MIRIS™.
- Nutritional Status of Mother and Child: Background: evidence suggests that programming may be induced by even mild intrauterine poor nutrition and may confer an increased risk of obesity, without neonates exhibiting birth weights below or above what is considered to be normal. Objectives: both maternal over- and undernutrition, seen as excess energy intake and/or deficiencies of micro- and macronutrients during (late) pregnancy, may increase infant fat mass. Methods: maternal food frequency questionnaire is adapted for pregnancy, an infant food frequency questionnaire is developed for the time span up to two years.
- Maternal Feeding Style and Child Eating Behaviour: Background: a strong maternal control of eating habits is associated with obesity in childhood. Objectives: a prospective investigation of associations between infant eating behaviour and weight gain to gather evidence on the time of establishment and the causal role of infant eating behaviours in weight gain and BMI at two years. Methods: also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and at 2 years.
- Infant Satiety Cues: Background: there is an increasing probability that bottle feeding habits, like encouraging the infants to drink the whole content of the bottle, develops overfeeding habits and causes a lower feeling of satiety. Objective: the identification of satiety cues may directly contribute to an objective method to assess satiety. Methods: a semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure (Noldus-Observer- XT™, Noldus-Media-Recorder™).
- Biomarker:
Background and Objectives: well-defined biomarkers of oxidative stress and inflammation, lipid profile, ghrelin, leptin, adipokines insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Methods: samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more.
.
- Conditions
- Childhood Obesity
- Being tested
- observation
- Keywords
- Breast Feeding, Exclusive versus Formula Feeding, Exclusive, satiety cues, childhood obesity, biomarker, nutritional status, infant body composition, infant weight gain velocity, metabolic programming, inflammation
- Medical subject headings
- Pediatric Obesity, Breast Feeding, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationBehavioural
Observation of growth, infant bodycomposition, 24h-drinkingvolume
| Study group | Role | What they receive |
|---|---|---|
| EBF exclusive breast fed children at 16 weeks | observation of 24 hours drinking volume, weight, length, body composition, biomarker and satiety cues, as well as eating- and feeding behaviour and nutritional status of exklusiv breastfed children at the age of 8 and 16 weeks, and at 1 and 2 Years Receives: Behavioral: observation | |
| EFF exclusive formula fed children at 16 week | observation of 24 hours drinking volume, weight, length, body composition, biomarker and satiety cues, as well as eating- and feeding behaviour and nutritional status of exklusiv formula fed children at the age of 8 and 16 weeks, and at 1 and 2 Years Receives: Behavioral: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 24 hours drinking volume of milk intake
24 hours drinking volume (milliliter) of milk intake of exclusive breast fed versus exclusive formula fed children by 24h-testweighing on an MBC-15K2DM-Infantscale (Kern).
Measured: Changes from 4 to 8 to 12 and to 16 weeks of life
Changes in Body Mass Index (BMI) child
weight in kilograms, height in meters will be combined to report BMI in (kg/m^2)
Measured: Changes from 4 to 8 to 12 and to 16 weeks of life up to 1 and 2 years
Changes in Fat Mass Index (FMI) child
weight of fat mass in kilograms, height in meters will be combined to report Fat Mass Index in kg/m^2). Fat mass will be measured by air displacement plethysmography (ADP) system using whole body densitometry to determine body composition (fat and fat-free mass) using a PEA-POD™ and BOD-POD™ (COSMED Company USA).
Measured: Changes from 8 to 16 weeks of life and 2 years
Change in energy content of mature breast milk
Change in energy content of 3 ml mature breast milk will be determined by MIRIS HMA™ Human Milk Analyzer (Miris Holding AB, Sweden) in kcal/dL. Samples will be measured twice and mean values for all measured parameters will be calculated. Milk samples are gained by use of Harmony Breast Pump kit (Medela Inc., USA) and are immediately frozen at -80 °C. The samples are collected between 9 and 11 AM from one breast simultaneously to feeding at the other breast. Foremilk and hindmilk are mixed, sample size will be at least 20 ml.
Measured: from 8 to 16 weeks of life
Duration of exclusive milk feeding
The duration of the exclusivity of human milk- or formula feeding will be determined by means of a prospective feeding diary in which frequency, volume, content, administration form and the initiation of complementary food are recorded by the mother. Precise classification by trained study staff will be according to the WHO categories "sole" (exclusive), "predominant" and "partial" breastfeeding through determination of ratio of total breast milk intake per day to total milk intake of other fluids (like formula milk, water, tea etc.) or foods.
Measured: over the period from 4 to 8 to 12 and to 16 weeks of life up to 1 and 2 years
Secondary outcomes (6)
Change of Eating Behaviour - baby
The validated Baby Eating and Behaviour Questionnaire (BEBQ) for parent-reported psychometric measurement of the general appetite of the infant during exclusive milk or formula feeding, containing 18 items measuring 4 appetitive traits: enjoyment of food (EF), food responsiveness (FR), slowness in eating (SE) and satiety responsiveness (SR). All items are scored on a 5-point scale as never, rarely, sometimes, often and always with mean scores for each subscale ranging from 1 to 5. Higher scores indicated higher EF and FR and lower SE and SR.
Measured: from 8 to 16 weeks of life
Change of Eating Behaviour - child
The "Child Eating and behaviour Questionnaire" (CEBQ) is same structured as the BEBQ and is containing 35 items, each rated on a five-point Likert scale that ranges from never to always. Additional to the traits of the BEBQ (Food responsiveness (FR), Enjoyment of food (EF), Satiety responsiveness (SR), Slowness in eating (SE)), four additional scales are added: Emotional over-eating (EOE), Desire to drink (DD), Emotional under-eating (EUE), and Food fussiness (FF). Subscale scores are calculated by taking the mean of the item ratings; higher scores reflect more the behaviour in question.
Measured: change from 1 year to 2 years of life
Change in Maternal Milk Feeding Style - Infant
Infant Milk Feeding Questionnaire (IMFQ) is a standardised multidimensional questionnaire for (self-)assessment of maternal control on food intake and eating habits of the infant (= maternal feeding style). It contains 25 items for measuring maternal control behaviour in 6 categories: 1) encouraging feeding, 2) feeding to a routine, 3) limiting intake, 4) concern for weight, 5) monitoring, 6) perceived responsibility. Each item is on a five-point Likert scale that ranges from never to always or disagree, slightly disagree, neutral, slightly agree, agree. This Questionnaire was modeled on the Child Feeding Questionnaire
Measured: from 8 to 16 weeks of life
Change in Maternal Feeding Style - Child
The Child Feeding Questionnaire (CFQ) is a standardised multidimensional questionnaire for (self-)assessment of maternal control on food intake and eating habits of the infant, with a focus on obesity proneness in children. It contains 31 items that can be classified in 7 subscales: 3 subscales that measured aspects of parental control over feeding and 4 that measured specific eating attitudes, perceived responsibility for feeding, and perceived parent weight. Responses to all items were coded on a Likert-type scale ranging from 1 (never/ in disagreement) to 5 (always/in agreement). Higher scores reflect more the behaviour in question.
Measured: From 1 year to 2 years of life
Changes in dietary intake - maternal
assessed with the "Food frequency questionnaire", a semi-quantitative, self-reported online-questionnaire, realised with the aid of a web-based open-source software
Measured: from 36 week of pregnancy to 16 weeks, to 1 year to 2 years of life
Change in dietary intake - infant
assessed with the "Infant food frequency questionnaire", a semi-quantitative, online-questionnaire, reported by the mother, realised with the aid of a web-based open-source software
Measured: change from 1 year to 2 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start16 Feb 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moenie van der Kleyn
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Christian Doppler Forschungsgesellschaft, Milupa GmbH
- Responsible party
- Sponsor-investigator, Moenie van der Kleyn, FH Joanneum Gesellschaft mbH
- Investigators
- Moenie van der Kleyn, MPH, Study director, FH Joanneum Hebammen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634930
- Sponsor's protocol ID
- PJM.16.001.01
- Acronym
- JRP
- Status last verified
- Mar 2025
- First submitted
- 24 Jul 2018
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Josef Ressel Centre for the Investigation of Early Life Metabolic Programming Regarding Dispositions of Obesity
- ClinicalTrials.gov ID
- NCT03634930
- Acronym / sponsor ID
- JRP / PJM.16.001.01
- Conditions
- Childhood Obesity
- Keywords
- Breast Feeding, Exclusive versus Formula Feeding, Exclusive, satiety cues, childhood obesity, biomarker, nutritional status, infant body composition, infant weight gain velocity, metabolic programming
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Moenie van der KleynIndustry (pharma, biotech, devices)
- Collaborators
- Christian Doppler Forschungsgesellschaft, Milupa GmbH
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three months of age. Breastfeeding in the first year of life appears to be protective against obesity development.
Objective: of the "Josef Ressel Centre for Early Life Metabolic Programming of Dispositions of Obesity" is to identify maternal and infant predictors of metabolic risk of obesity. The main considerations of modifiable factors are early infant nutrition, 24-hours-drinking-volume, the velocity of infant weight gain, in relation to infant fat mass and fat free mass, to biomarker and to the nutritional status of the mother. A second focus is put on maternal feeding style, infant eating behaviour and the identification of satiety cues.
Multi-Study design: a monocentric prospective longitudinal cohort of 100 healthy, non-obese, non-smoking pregnant mothers and their term, normal birthweight, singleton babies. Mothers and exclusively breastfed versus exclusively formula fed children (at 16 weeks) will be examined at 36 weeks of pregnancy, 4 - 8 - 12 and 16 weeks of life, follow-up at 1 and 2 years of life.
Methods: four weighing protocols between 4th and 16th week of life, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph. Macronutrient and energy content of the breast milk will be analysed by MIRIS™.
Well-defined biomarkers of oxidative stress and inflammation, lipid profile, adipokines, insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more. Also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and 2 years.
A semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure.
Detailed description
Nutrition related diseases such as obesity are considered as the main health problems in the 21st century. Overweight and obesity are significant risk factors regarding the development of cardiovascular diseases, strokes, diabetes mellitus, and other non-communicable diseases. In the "Josef Ressel Centre for the Investigation of Early Life Metabolic Programming regarding Dispositions of Obesity" possible predictors towards obesity and their relationship to the volume uptake of formula are to be explored multi-dimensionally. During the first part of the project, the volume study, including a total of 66 mother-infant pairs at the 16th week of life, the overfeeding of infants will be investigated. Overfeeding of infants can be regarded in the context of the amount of food consumed, the ingredients, or in the context of satiety perception of babies by their mother. A closer inspection of the drinking volume of breast-fed infants in comparison to formula-fed ones could give an indication of how much and in what frequency infants ingest food and how the drinking volume affects the weight gain and body fat percentage. To do so, applicable anthropometric data will be collected and the measurement of body fat from mothers and infants will be carried out. Additionally, a semi-automatic detection of satiety signals during feeding will be performed. The identification of satiety signs and the reaction of the mother to those signals, in addition with the feeding style, are related to the weight of the infant and its risk of becoming obese later in life. During the second part of the research project, it will be emphasized whether a coherence exists between early infant nutrition and the manifestation of biomarkers of oxidative stress and inflammation. Thus, detailed analyses regarding macro- and micronutrients, adipokines and biomarkers of oxidative stress of mother milk and biological specimen from mothers and infants will be performed Furthermore, the microbiome of the gut of mothers and infants will be investigated. Results from bioanalytical experiments are intended to sup-port the interpretation of results from the volume study to perceive a deep understanding of the metabolic programming phenomenon of infants at the molecular level.
The five main areas of investigation are:
- 24-hours-drinking-volume: Background: beyond the quality of nutrition during neonatal life, also the quantity in terms of overfeeding plays a critical role in the development of obesity. Objective: to derive evidence on the drinking volume of exclusively breastfed versus exclusively formula fed children, applying strictly the WHO definitions of exclusivity. Secondary objective is the integration of body composition and growth velocity, which may contribute to insights on critical time slots for programming overweight. Methods: weighing protocol, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph PeaPod™ and BodPod™ of the company Cosmed™. The macronutrient and energy content of the breast milk will be also analyzed by MIRIS™.
- Nutritional Status of Mother and Child: Background: evidence suggests that programming may be induced by even mild intrauterine poor nutrition and may confer an increased risk of obesity, without neonates exhibiting birth weights below or above what is considered to be normal. Objectives: both maternal over- and undernutrition, seen as excess energy intake and/or deficiencies of micro- and macronutrients during (late) pregnancy, may increase infant fat mass. Methods: maternal food frequency questionnaire is adapted for pregnancy, an infant food frequency questionnaire is developed for the time span up to two years.
- Maternal Feeding Style and Child Eating Behaviour: Background: a strong maternal control of eating habits is associated with obesity in childhood. Objectives: a prospective investigation of associations between infant eating behaviour and weight gain to gather evidence on the time of establishment and the causal role of infant eating behaviours in weight gain and BMI at two years. Methods: also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and at 2 years.
- Infant Satiety Cues: Background: there is an increasing probability that bottle feeding habits, like encouraging the infants to drink the whole content of the bottle, develops overfeeding habits and causes a lower feeling of satiety. Objective: the identification of satiety cues may directly contribute to an objective method to assess satiety. Methods: a semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure (Noldus-Observer- XT™, Noldus-Media-Recorder™).
- Biomarker:
Background and Objectives: well-defined biomarkers of oxidative stress and inflammation, lipid profile, ghrelin, leptin, adipokines insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Methods: samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBF exclusive breast fed children at 16 weeks | – | Behavioral: observationobservation of 24 hours drinking volume, weight, length, body composition, biomarker and satiety cues, as well as eating- and feeding behaviour and nutritional status of exklusiv breastfed children at the age of 8 and 16 weeks, and at 1 and 2 Years |
| EFF exclusive formula fed children at 16 week | – | Behavioral: observationobservation of 24 hours drinking volume, weight, length, body composition, biomarker and satiety cues, as well as eating- and feeding behaviour and nutritional status of exklusiv formula fed children at the age of 8 and 16 weeks, and at 1 and 2 Years |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- term (37-41 gestational age), singleton healthy babies with normal birth weight (2.5-4.5 kg) from healthy, non-smoking, non-diabetic mothers with a normal pre-pregnancy BMI (18.5-30). Pregnant women, who plan to breastfeed will be selected from a primary care clinic (STGKK Graz) and young non-breastfeeding mothers will be selected at the maternity ward of the university hospital of Graz.
Key inclusion criteria (10 listed)
- Pregnancy or mother in puerperium
- Delivery of baby at 37+0 to 41+6 gestational age
- Legal age (18 years old), age limit 50 years
- Written consent of test person after having been informed
- BMI ≥ 18.5 kg/m² to < 30 kg/m²
Key exclusion criteria (23 listed)
- Birth before 37+0 week of pregnancy (WoP) or after the 41+6 WoP
- Multiple pregnancy
- Children with serious congenital malformations of
- Diseases or hospitalization or intensive medical care of child during neonatal period
- Hereditary metabolic diseases of child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationObservation of growth, infant bodycomposition, 24h-drinkingvolume | Behavioural | EBF exclusive breast fed children at 16 weeks, EFF exclusive formula fed children at 16 week |
Primary outcome
Changes in 24 hours drinking volume of milk intake
Time frame: Changes from 4 to 8 to 12 and to 16 weeks of life
24 hours drinking volume (milliliter) of milk intake of exclusive breast fed versus exclusive formula fed children by 24h-testweighing on an MBC-15K2DM-Infantscale (Kern).
Changes in Body Mass Index (BMI) child
Time frame: Changes from 4 to 8 to 12 and to 16 weeks of life up to 1 and 2 years
weight in kilograms, height in meters will be combined to report BMI in (kg/m^2)
Changes in Fat Mass Index (FMI) child
Time frame: Changes from 8 to 16 weeks of life and 2 years
weight of fat mass in kilograms, height in meters will be combined to report Fat Mass Index in kg/m^2). Fat mass will be measured by air displacement plethysmography (ADP) system using whole body densitometry to determine body composition (fat and fat-free mass) using a PEA-POD™ and BOD-POD™ (COSMED Company USA).
Change in energy content of mature breast milk
Time frame: from 8 to 16 weeks of life
Change in energy content of 3 ml mature breast milk will be determined by MIRIS HMA™ Human Milk Analyzer (Miris Holding AB, Sweden) in kcal/dL. Samples will be measured twice and mean values for all measured parameters will be calculated. Milk samples are gained by use of Harmony Breast Pump kit (Medela Inc., USA) and are immediately frozen at -80 °C. The samples are collected between 9 and 11 AM from one breast simultaneously to feeding at the other breast. Foremilk and hindmilk are mixed, sample size will be at least 20 ml.
Duration of exclusive milk feeding
Time frame: over the period from 4 to 8 to 12 and to 16 weeks of life up to 1 and 2 years
The duration of the exclusivity of human milk- or formula feeding will be determined by means of a prospective feeding diary in which frequency, volume, content, administration form and the initiation of complementary food are recorded by the mother. Precise classification by trained study staff will be according to the WHO categories "sole" (exclusive), "predominant" and "partial" breastfeeding through determination of ratio of total breast milk intake per day to total milk intake of other fluids (like formula milk, water, tea etc.) or foods.
6 secondary outcomes
Change of Eating Behaviour - baby
Time frame: from 8 to 16 weeks of life
Change of Eating Behaviour - child
Time frame: change from 1 year to 2 years of life
Change in Maternal Milk Feeding Style - Infant
Time frame: from 8 to 16 weeks of life
Change in Maternal Feeding Style - Child
Time frame: From 1 year to 2 years of life
Changes in dietary intake - maternal
Time frame: from 36 week of pregnancy to 16 weeks, to 1 year to 2 years of life
Change in dietary intake - infant
Time frame: change from 1 year to 2 years of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Homepage of Josef Ressel Centre for the Investigation of Early Live Metabolic Programming regarding Dispositions of ObesityLink provided by the sponsor.
- Homepage of FH Joanneum, university of applied sciencesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moenie van der Kleyn, MPH study director
FH Joanneum Hebammen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Moenie van der Kleyn at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moenie D van der Kleyn, MPH (++ 43 316 5453 ext. 6610, moenie.vanderkleyn@fh-joanneum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 24 hours drinking volume of milk intake (time frame: Changes from 4 to 8 to 12 and to 16 weeks of life). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.