Determine if Human Infant Weight Gain Can be Modulated to Prevent Obesity

NCT04526860 | Withdrawn DMC

• 1 other identifier: 31686-01R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The global obesity epidemic has extended to low and middle income countries (LMICs) in which in a dramatic nutritional transition has shifted from maternal/child undernutrition to overnutrition. Within Brazil, maternal overweight/obesity (OW/OB) and childhood obesity have dramatically increased. During developmental periods, exposure to maternal OB and high-fat diet increases the risk of childhood and adult obesity, in part a result of increased food intake. Studies confirm that offspring of overweight and obese (OW/OB) women are at increased risk of newborn and age 1 year adiposity, and infant adiposity predicts childhood and adult obesity. The investigators hypothesize that that infants of OW/OB mothers have both relative increased appetite and are provided human milk with increased caloric composition. The investigators propose that calibrating milk or formula intake in infants of overweight mothers can reduce the incidence of infant obesity.

Conditions

Obesity, Infant

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)

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 2 standard deviations of normal WHO weight standards, in order to prevent infant obesity and subsequent childhood obesity.

Calibrated Infant Feed Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Breast Milk Calibration Study: Study women (pre-pregnant BMI\>30) who are providing exclusive human milk via pumping and bottle (50%/50% male/female) will be recruited at the 7-9 week postpartum visit.
• Formula Milk Calibration Study: Study women (pre-pregnant BMI\>30) who are providing formula via bottle (50%/50% male/female) will be recruited at the 7-9 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
• Federal University of São Paulo: collaborator

Study Sites (1)

Breastfeeding Center Ana Abrao, Federal of São Paulo University, Brazil

São Paulo, São Paulo, 04025-002, Brazil

Location

Related Publications (10)

• Conde WL, Monteiro CA. Nutrition transition and double burden of undernutrition and excess of weight in Brazil. Am J Clin Nutr. 2014 Dec;100(6):1617S-22S. doi: 10.3945/ajcn.114.084764. Epub 2014 Oct 29.

  PMID: 25411303 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

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

  The Lundquist Institute

  PRINCIPAL INVESTIGATOR

• Mina Desai, PhD

  The 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 2 standard deviations of normal WHO weight standards, in order to prevent infant obesity and subsequent childhood obesity.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start (Estimated): December 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

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

Locations

BR (1)