Investigating early nutrition's impact on childhood obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.