Investigating early nutrition's impact on childhood obesity
Josef Ressel Centre for the Investigation of Early Life Metabolic Programming Regarding Dispositions of Obesity
This study is trying to see how different ways of feeding babies, like breastfeeding or formula, affect their chances of becoming obese as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | FH Joanneum Gesellschaft mbH Industry-sponsored |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT03634930 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify maternal and infant predictors of metabolic risk for obesity by examining the effects of early infant nutrition, including breastfeeding and formula feeding. It will involve a longitudinal cohort of 100 healthy, non-obese, non-smoking pregnant mothers and their infants, focusing on factors such as drinking volume, weight gain velocity, and maternal feeding styles. The study will collect anthropometric data and measure body fat in both mothers and infants, while also observing satiety cues during feeding. The goal is to understand how these factors contribute to obesity risk in early childhood.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-obese, non-smoking pregnant women aged 18 to 50 who are fluent in German and can provide informed consent.
Not a fit: Patients with multiple pregnancies, serious congenital malformations, or significant neonatal health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective nutritional strategies to prevent childhood obesity.
How similar studies have performed: Other studies have shown promising results in understanding the relationship between early nutrition and obesity, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pregnancy or mother in puerperium 2. Delivery of baby at 37+0 to 41+6 gestational age 3. Legal age (18 years old), age limit 50 years 4. Written consent of test person after having been informed 5. BMI ≥ 18.5 kg/m² to \< 30 kg/m² 6. Negative result of oGTT (oral glucose tolerance test) during pregnancy 7. Birth weight of baby 2.5-4.5 kg 8. Non-smoker since knowledge of pregnancy 9. Very good knowledge of German language and Caucasian 10. Exclusive breastfeeding or exclusive formula feeding at MR 2 (4th week of life) Exclusion Criteria: 1. Birth before 37+0 week of pregnancy (WoP) or after the 41+6 WoP 2. Multiple pregnancy 3. Children with serious congenital malformations of * Nervous system * Mouth, throat, neck * Circulation system * Respiratory tract * Gastrointestinal tract * Urogenital tract * Chromosomal aberrations 4. Diseases or hospitalization or intensive medical care of child during neonatal period 5. 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) 6. Drug (tobacco) abuse 7. Mental illnesses that have to be treated with medicaments 8. Metabolic or autoimmune diseases of mother 9. Complications at birth (blood loss \> 1000 ml or eclampsia) 10. Pre-conceptional diabetes (type 1 or 2) 11. Celiac disease and/or wheat protein allergy of mother 12. Breast surgery and/or hypomastia 13. Mixed feeding at MR 2 (4th week of life)
Where this trial is running
Graz, Styria
- FH Joanneum, university of applied sciences — Graz, Styria, Austria (Recruiting)
Study contacts
- Study coordinator: Moenie D van der Kleyn, MPH
- Email: moenie.vanderkleyn@fh-joanneum.at
- Phone: ++ 43 316 5453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.