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

NCT ID: NCT04526860

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-20
• Study Completion Date: 2028-12-01

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.

Detailed Description

This is a clinical intervention study to calibrate infant milk or formula intake and modulate infant weight gain to prevent the development of infant obesity. The studies will be performed at the Ana Abrão Breastfeeding Center, Federal University of São Paulo, Brazil.

Postpartum women will be with pre-pregnant BMI 30 who are providing exclusive human milk via pumping and bottle (n = 50; 50 percent male and 50 percent female) will be recruited at the 7-9 week postpartum visit, Study women will be randomly assigned (computer generated; blocks of 10) to a Standard Feed (SF) or Calibrated Feed (CF) groups. Both groups will be seen at 2 week intervals for assessment of infant weight, supine length, BMI and skinfold thickness. Continuation of exclusive human milk will be confirmed with questionnaires.

In the SF group, mothers will provide bottled human milk ad libitum. In the CF group, infant weight will be assessed in relation to the daily milk volume and approximate caloric intake (based upon maternal human milk sample analysis). Should infants be within 10th to 90th percentile of WHO BMI growth curves, no intervention will be made. Should the infant be greater than 90th percentile of WHO BMI, the provided human milk volume and daily calorie intake will be adjusted in relation to previously established normal volumes for newborn age, with the input of pediatric physician. In no case, will the daily milk volume or calorie intake be reduced by more than 10%. At the subsequent visit, adjustments in milk volume and calorie intake will continue, dependent upon the infant BMI trend, accommodating the normal increase in milk intake with advancing age. Should the infant be less than 10th percentile of WHO BMI, the maternal- infant dyad will be referred for a pediatric and nutrition consults to assess the cause and treatment for potential nutrient deficiency. At 26 wks, the investigators will assess the distribution of infant weight BMI between SF and CF groups.

An identical Study will be undertaken (Standard Feed and Calibrated Feed), with the exception that only current formula feed mothers will be enrolled. All women will be provided a standard brand of commercial formula feed, for which total caloric content and composition will be determined.

Data Analysis. The investigators will compare standard feed vs calibrated feed infant BMI curves with repeated measures ANOVA (time, BMI) with covariates of the group assignment. The investigators will compare infant weight and BMI curves by maternal BMI and infant birth weight, and between human milk and formula groups. The investigators will analyze growth curves of infants exceeding WHO standards which received adjustments in feedings to assess if early changes in growth curves or milk composition is predictive of weight changes, so as to determine the potential for interventions prior to 90th percentile.

Conditions

Obesity, Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Infant Feed Group

Infants will receive human milk or formula milk ad libitum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Calibrated Infant Feed Group

Infants will have reduced human milk or formula milk intake.

Group Type: OTHER

Calibration of infant breast milk and formula milk intake

Intervention Type: 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.

Interventions

Calibration of infant breast milk and formula milk 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Ross

Distinguished Professor of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael G Ross, MD

Role: PRINCIPAL_INVESTIGATOR

The Lundquist Institute

Mina Desai, PhD

Role: PRINCIPAL_INVESTIGATOR

The Lundquist Institute

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 30968129 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30092608 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24729519 (View on PubMed)

Other Identifiers

31686-01R

Identifier Type: -

Identifier Source: org_study_id