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

July 7, 2023 updated by: Michael Ross, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Maternal Obesity Programs Offspring Hypothalamic Neurogenesis and Appetite: Mechanisms and Prevention of Hyperphagia-mediated Childhood Obesity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kelly P Coca, RNM, PhD
  • Phone Number: 1625 +55 11 5576-4430
  • Email: kcoca@unifesp.br

Study Contact Backup

Study Locations

  • Brazil
    • San Paulo
      • Sao Paulo, San Paulo, Brazil, 04025-002
        • Breastfeeding Center Ana Abrao, Federal of São Paulo University, Brazil
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Mother infant dyads are eligible for the study, with equal proportion of male and female infant in each study group.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Calibrated Infant Feed Group
Infants will have reduced human milk or formula milk intake.
Other: 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.
No Intervention: Standard Infant Feed Group
Infants will receive human milk or formula milk ad libitum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant normalized weight at 6 months of age
Time Frame: 6 months
We will quantify effects of calibrated human milk or formula intake on the normalized weight of infants at 6 months of age.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Federal University of São Paulo

Investigators

  • Principal Investigator: Michael G Ross, MD, The Lundquist Institute
  • Principal Investigator: Mina Desai, PhD, The Lundquist Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 21, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31686-01R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared at national and international meetings spanning obstetrics, pediatrics and public health. The findings of the study will be published according to NIH guideline for publication and accepted manuscripts will be deposited to Pub Med Central to ensure public access.

For the Brazilian community, we will disseminate research data through educational program, workshops and conferences organized by the Brazil Ministry of Health. It is important to note that we plan to translate our research findings first into Portuguese (language of Brazil) as well as Spanish which is the predominant language spoken in our neighboring countries surrounding Brazil.

IPD Sharing Time Frame

Data available at completion of protocol estimated Dec 2023

IPD Sharing Access Criteria

Established research organization

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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