CompletedNot Applicable

Prevention of Obesity in Infants of Overweight and Obese Women

United States60 participantsStarted 2022-01-01

Plain-language summary

Maternal and childhood obesity have dramatically increased and continue to present a significant health problem. Studies show that offspring of overweight (body mass index, BMI \>25-29.9) and obese (BMI ≥30) women are at increased risk of newborn and age 1-year adiposity, and infant adiposity predicts childhood and adult obesity. The investigators hypothesize that infants of overweight/obese (OW/OB) mothers have both relative hyperphagia and are provided human milk with increased caloric composition, leading to obesity. The investigators propose an intervention study to calibrate milk or formula intake in infants of OW/OB mothers so as to avoid overweight infants at 6 months of age.

Who can participate

Age range16 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Breast Milk Calibration Study: Study women (pre-pregnant BMI 25-29.9 and ≥30) who are providing exclusive human milk via pumping and bottle (50%/50% male/female) will be recruited at the 3-6 week postpartum visit. * Formula Milk Calibration Study: Study women (pre-pregnant BMI 25-29.9 and ≥30) who are providing formula via bottle (50%/50% male/female) will be recruited at the 3-6 week postpartum visit. Exclusion Criteria: * Breast Milk Calibration Study: breast implants, prior breast surgery, flat/ inverted nipples, tongue-tie or low birth weight infants. * Formula Milk Calibration Study: low birth weight infants.

What they're measuring

Infant normalized weight at 6 months of age

Timeframe: 6 months

Trial details

NCT IDNCT04782063

SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-30