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Obesity, ChildhoodNCT06039878

Mother-Baby Study - Observational

A study testing Bonding-Evoked Oxytocin, Distress Relieving Effects of Sucrose and Hedonic Response to Sucrose in people with Obesity, Childhood and Obesity, run by University of Michigan at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The rate of weight gain in the first year of life is risk factor for future obesity. The study will test (1) a model of l mechanisms underlying the development of emotion, attachment, and nutritive intake; and (2) the association with maternal feeding behavior, child eating behavior, dietary intake, and adiposity. Read more about this study

Who is it for?
Ages 0 days and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood, Obesity
What is being tested?
Bonding-Evoked Oxytocin, Distress Relieving Effects of Sucrose and Hedonic Response to Sucrose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
21 Dec 2023to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 0 days and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

To be eligible to participate in this study, they mother-child dyad must meet all of the following criteria:

  1. Provision of signed and dated informed consent form by mother for herself and infant
  2. Stated willingness by mother to comply with all study procedures and availability for the duration of the study
  3. Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and child's birth date
  4. Infant birth weight by maternal report appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set.
  5. Mother is biological mother both genetically and gestationally by maternal report (i.e., conception with her own (versus donor) egg and she was pregnant (versus a surrogate)
  6. Biological mother is legal guardian by maternal report
  7. Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time)
  8. Infant has fed at least 2.0 ounces in one feeding from an artificial nipple and bottle by maternal report or mother reports planning to do prior to first task requiring artificial nipple and bottle during age 1.0 month data collection window

Any dyad who meets any of the following criteria will be excluded from participation in this study:

  1. Limited English proficiency in the mother; this is necessary because the questionnaires have only been validated in English-speaking populations.
  2. Participation in another study involving treatment or intervention focused on mother or child emotion or attachment, child eating behavior, child dietary intake, or child growth
  3. Mother < 18.0 years old at time of consent prior to infant's first data collection window
  4. Significant medical problems in the child or known diagnosis as reported by the mother that has significant potential to affect current or future eating, growth or development in the child as evaluated by PI Lumeng (e.g., cystic fibrosis, cleft palate, trisomy 13).
  5. Significant medical problems in the mother as reported by the mother and assessed for significance by PI Lumeng (i.e., cancer, lupus)
  6. Mother or infant taking medications likely to have significant effect on biological measures in study (e.g., steroids)
  7. Family lives more than 1.5 hour driving distance from the University of Michigan. This is necessary to ensure study feasibility.
  8. Family plans to move outside 1.5 hour driving distance from the University of Michigan before end of age 36-month data collection window. This is necessary to ensure study feasibility.
  9. Child is product of multiple gestation (i.e., twins, triplets)
  10. Significant complications for mother or infant during the pregnancy as assessed by PI Lumeng (e.g., eclampsia, preterm premature rupture of membranes)
  11. Significant complications for mother or infant during the perinatal period as assessed by PI Lumeng (e.g., sepsis, hemorrhage requiring transfusion, persistent pulmonary hypertension of the newborn)

All participants must be enrolled in all parts of the Mother-Baby study (1 Observational study and 4 Clinical Trials)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad

The rate of weight gain in the first year of life is risk factor for future obesity. The study will test (1) a model of l mechanisms underlying the development of emotion, attachment, and nutritive intake; and (2) the association with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

Read the detailed description

This multi-year study was originally accurately registered as an observational study. The outcome measures are not measuring dependent variables based on the interventions; rather the interventions are experiments to categorize infant responses for the purpose of grouping infants according to their behaviors. There are small trials associated with the grant at National Clinical Trial numbers (NCT #s): NCT06072664, NCT06072651, and NCT06072638 to analyze behaviors at 18 and 36 months of age. However, because the NIH grant covering this study needs to be linked to a trial for computer smart logic purposes, and this overarching study connects with the most complete enrollment numbers, the record was modified in 2024 to show it as a trial.

Being tested
Bonding-Evoked Oxytocin, Distress Relieving Effects of Sucrose, Hedonic Response to Sucrose, Typical versus Challenging Feeding-Social, Caloric Compensation-Social
Keywords
weight gain
Medical subject headings
Pediatric Obesity, Obesity, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bonding-Evoked OxytocinBehavioural

    Mother participates in bonding activity with infant at ages 1, 3, and 6 months

  • Distress Relieving Effects of SucroseBehavioural

    Researcher elicits distress in the infant (sequence of unswaddling, pacifier removal, and arm restraint), followed by delivery of oral sucrose in one condition and water in other condition

  • Hedonic Response to SucroseBehavioural

    Researcher gives infant opportunity to suck from two bottles, one containing sucrose and one plain water at infant ages 1, 3, and 6 months

  • Typical versus Challenging Feeding-SocialBehavioural

    Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) regular size nipple versus smaller aperture nipple ('challenging') and (2) providing social interaction while feeding versus not.

  • Caloric Compensation-SocialBehavioural

    Mother feeds infant on four counterbalanced days at infant ages 1, 3, and 6 months crossing two conditions: (1) offering a bottle feeding ad lib for 3 hours versus offering a bottle feeding every hour for 3 hours; (2) providing social interaction while feeding versus not.

  • Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)Behavioural

    When mother indicates infant is hungry, she presents the infant the bottle but withholds feeding for 5 minutes, feeds for one minute, withholds feeding for 30 seconds, and then resumes feeding. She does so under two conditions (providing social interaction during feeding versus not) on two counterbalanced days at infant ages 1, 3, and 6 months.

Study groups in NCT06039878
Study groupRoleWhat they receive
Mother-Infant DyadExperimentalThe researchers will enroll 150 infants and their mothers (150 dyads, 300 total participants). The researchers anticipate, based on prior experience and the slightly more restrictive inclusion and exclusion criteria in this study compared to our prior work, needing to screen about 600 mother-infant dyads to achieve the target sample size of 150. The researchers anticipate that the sample will be 63% non-Hispanic white, 13% non-Hispanic black, 4% non-Hispanic Asian, 12% non-Hispanic multiracial, and 8% Hispanic (any race). The researchers expect that 50% of the infants will be male and 50% female, and all of the biological mothers will be female sex. Infants will be 0.5-1.5 months at enrollment and the researchers estimate that mothers will be between 18.0 and 50.0 at enrollment (upper age limit is estimated due to menopause ).
Receives: Behavioral: Bonding-Evoked Oxytocin; Behavioral: Distress Relieving Effects of Sucrose; Behavioral: Hedonic Response to Sucrose; Behavioral: Typical versus Challenging Feeding-Social; Behavioral: Caloric Compensation-Social; Behavioral: Ability to Delay Gratification for Food in Infants-Social Task (ATDG-FIT-Social)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight-for-length z-score

    Infants will be weighed and length will be measured recumbent using an infantometer. Weight-for-length will be calculated and z-scored against World Health Organization growth charts

    Measured: Up to 36 months (infant age)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start21 Dec 2023
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039878
Sponsor's protocol ID
HUM00227836
Other IDs
R01DK134979
Status last verified
May 2026
First submitted
10 Sep 2023
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bonding-Evoked Oxytocin, Distress Relieving Effects of Sucrose and Hedonic Response to Sucrose in people with Obesity, Childhood and Obesity, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Weight-for-length z-score (time frame: Up to 36 months (infant age)). 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 NCT06039878.

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 9 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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