Prevention of Obesity in Infants of Overweight and Obese Women

NCT04782063 | Completed DMC

• 1 other identifier: 32035-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Obesity

Keywords

Obesity; Hyperphagia; Breast Milk

Outcome Measures

Primary Outcomes (1)

• Infant normalized weight at 6 months of age

  We will quantify effects of calibrated human milk or formula intake on the normalized weight of infants at 6 months of age.

  6 months

Study Arms (2)

No Intervention: Standard Infant Feed Group

NO INTERVENTION

Infants will receive human milk or formula milk ad libitum.

Calibrated Infant Feed Group

OTHER

Infants will have reduced human milk or formula milk intake.

Other: Calibration of infant breast milk and formula milk intake

Interventions

Calibration of infant breast milk and formula milk intake OTHER

We will calibrate (reduce) the pumped breast milk or formula intake of infants of overweight and obese mothers who exceed 75%ile of WHO BMI, in order to prevent infant obesity and subsequent childhood obesity.

Calibrated Infant Feed Group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (9)

• Brunner S, Schmid D, Zang K, Much D, Knoeferl B, Kratzsch J, Amann-Gassner U, Bader BL, Hauner H. Breast milk leptin and adiponectin in relation to infant body composition up to 2 years. Pediatr Obes. 2015 Feb;10(1):67-73. doi: 10.1111/j.2047-6310.2014.222.x. Epub 2014 Apr 14.

  PMID: 24729519 BACKGROUND

• Satpathy HK, Fleming A, Frey D, Barsoom M, Satpathy C, Khandalavala J. Maternal obesity and pregnancy. Postgrad Med. 2008 Sep 15;120(3):E01-9. doi: 10.3810/pgm.2008.09.1920.

  PMID: 18824817 RESULT

• Kaul P, Bowker SL, Savu A, Yeung RO, Donovan LE, Ryan EA. Association between maternal diabetes, being large for gestational age and breast-feeding on being overweight or obese in childhood. Diabetologia. 2019 Feb;62(2):249-258. doi: 10.1007/s00125-018-4758-0. Epub 2018 Nov 13.

  PMID: 30421138 RESULT

• Davenport MH, Cabrero MR. Maternal nutritional history predicts obesity in adult offspring independent of postnatal diet. J Physiol. 2009 Jul 15;587(Pt 14):3423-4. doi: 10.1113/jphysiol.2009.174896. No abstract available.

  PMID: 19602635 RESULT

• Guo SS, Wu W, Chumlea WC, Roche AF. Predicting overweight and obesity in adulthood from body mass index values in childhood and adolescence. Am J Clin Nutr. 2002 Sep;76(3):653-8. doi: 10.1093/ajcn/76.3.653.

  PMID: 12198014 RESULT

• Catalano PM. Obesity and pregnancy--the propagation of a viscous cycle? J Clin Endocrinol Metab. 2003 Aug;88(8):3505-6. doi: 10.1210/jc.2003-031046. No abstract available.

  PMID: 12915626 RESULT

• Prentice P, Ong KK, Schoemaker MH, van Tol EA, Vervoort J, Hughes IA, Acerini CL, Dunger DB. Breast milk nutrient content and infancy growth. Acta Paediatr. 2016 Jun;105(6):641-7. doi: 10.1111/apa.13362. Epub 2016 Apr 6.

  PMID: 26865238 RESULT

• Isganaitis E, Venditti S, Matthews TJ, Lerin C, Demerath EW, Fields DA. Maternal obesity and the human milk metabolome: associations with infant body composition and postnatal weight gain. Am J Clin Nutr. 2019 Jul 1;110(1):111-120. doi: 10.1093/ajcn/nqy334.

  PMID: 30968129 RESULT

• Young BE, Levek C, Reynolds RM, Rudolph MC, MacLean P, Hernandez TL, Friedman JE, Krebs NF. Bioactive components in human milk are differentially associated with rates of lean and fat mass deposition in infants of mothers with normal vs. elevated BMI. Pediatr Obes. 2018 Oct;13(10):598-606. doi: 10.1111/ijpo.12394. Epub 2018 Aug 9.

  PMID: 30092608 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Hyperphagia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Michael G Ross, MD

  Lundquist Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Obstetrics & Gynecology

Model Details: Calibration of infant breast milk and formula intake: We will calibrate (reduce) the pumped breast milk or formula intake of infants of overweight and obese mothers who exceed 75%ile of WHO BMI, in order to prevent infant obesity and subsequent childhood obesity.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: January 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data available at completion of protocol estimated Nov 2023
• Access Criteria: Established research organization

Locations

US (1)