Obesity, InfantNCT04526860
Determine if Human Infant Weight Gain Can be Modulated to Prevent Obesity
A study testing Calibration of infant breast milk and formula milk intake in people with Obesity, Infant, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Infant
- What is being tested?
- Calibration of infant breast milk and formula milk intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Breastfeeding Center Ana Abrao, Federal of São Paulo University, Brazil
São Paulo, São Paulo, 04025-002
About this study
Official title: 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.
Read the 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
- Being tested
- Calibration of infant breast milk and formula milk intake
- Keywords
- obesity, hyperphagia, breast milk
- Medical subject headings
- Pediatric Obesity, Obesity, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calibration of infant breast milk and formula milk intakeOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Calibration of infant breast milk and formula milk intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start20 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Why it stopped: funding period ended, impact of Covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obesity, InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Michael Ross, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Michael G Ross, MD, Principal investigator, The Lundquist InstituteMina Desai, PhD, Principal investigator, The Lundquist Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526860
- Sponsor's protocol ID
- 31686-01R
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25411303Satpathy 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.
PubMed 18824817Kaul 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.
PubMed 30421138Davenport 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.
PubMed 19602635Guo 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.
PubMed 12198014Catalano 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.
PubMed 12915626Prentice 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.
PubMed 26865238Isganaitis 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.
PubMed 30968129Young 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.
PubMed 30092608Brunner 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.
PubMed 24729519
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Obesity Programs Offspring Hypothalamic Neurogenesis and Appetite: Mechanisms and Prevention of Hyperphagia-mediated Childhood Obesity
- ClinicalTrials.gov ID
- NCT04526860
- Acronym / sponsor ID
- 31686-01R
- Conditions
- Obesity, Infant
- Keywords
- obesity, hyperphagia, breast milk
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding period ended, impact of Covid
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Infant Feed Group | No intervention | –Infants will receive human milk or formula milk ad libitum. |
| Calibrated Infant Feed Group | Other | Other: Calibration of infant breast milk and formula milk intakeInfants will have reduced human milk or formula milk intake. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calibration of infant breast milk and formula milk intakeWe 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. | Other | Calibrated Infant Feed Group |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 25411303Conde 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.
- Background: PubMed 18824817Satpathy 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.
- Background: PubMed 30421138Kaul 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.
- Background: PubMed 19602635Davenport 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.
- Background: PubMed 12198014Guo 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.
- Background: PubMed 12915626Catalano 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.
- Background: PubMed 26865238Prentice 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.
- Background: PubMed 30968129Isganaitis 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.
- Background: PubMed 30092608Young 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.
- Background: PubMed 24729519Brunner 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Ross, MD principal investigator
The Lundquist Institute
Mina Desai, PhD principal investigator
The Lundquist Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calibration of infant breast milk and formula milk intake in people with Obesity, Infant, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant normalized weight at 6 months of age (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526860, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.