Obesity; FamilialNCT06358729
Pre-Pregnancy Weight Loss and Baby Behavior Study
A study testing Typical Nipple and Challenging Nipple in people with Obesity; Familial and Pregnancy Related, run by University of Michigan at 1 site in United States.
Trial summary
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity; Familial, Pregnancy Related, Infant Behavior
- What is being tested?
- Typical Nipple and Challenging Nipple
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 22 Jul 2025
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
To be eligible to participate in this study...
Mother
-Current or previous participation in the PLAN study resulting in a live birth.
Child
- Mother participated in PLAN study during child's gestation
- Infant birth weight (From PLAN study records) appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set (Oken et al, BMC Pediatrics 2003).
- Infant is 3.0 to 6.0 months old at Consent.
- Biological mother is legal guardian by maternal report.
- Biological mother is full time custodial guardian by maternal report (versus sharing custody such that infant does not live with her full time).
- Infant typically consumes at least 2 ounces in one feeding from an artificial nipple and bottle at least once per week by maternal report.
- Stated willingness by mother to comply with all study procedures and availability for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
Read the detailed description
The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.
- Conditions
- Obesity; Familial, Pregnancy Related, Infant Behavior
- Being tested
- Typical Nipple, Challenging Nipple
- Medical subject headings
- Obesity, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typical NippleBehavioural
Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple.
Challenging NippleBehavioural
Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery).
| Study group | Role | What they receive |
|---|---|---|
| Nipple order 1 | Experimental | First the typical nipple and then challenging nipple Receives: Behavioral: Typical Nipple; Behavioral: Challenging Nipple |
| Nipple order 2 | Experimental | First the challenging nipple and then the typical nipple Receives: Behavioral: Typical Nipple; Behavioral: Challenging Nipple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suck effect
Sucking will be measured with the NFANT® Feeding Solution
Measured: Up to 6 weeks
Secondary outcomes (7)
Sucking pressure
Sucking will be measured with the NFANT® Feeding Solution
Measured: Up to 6 weeks
Sucking frequency
Sucking will be measured with the NFANT® Feeding Solution
Measured: Up to 6 weeks
Milk/Formula intake
Measured: Up to 6 weeks
Milk/Formula consumption rate
Measured: Up to 6 weeks
Number of Feedings Over 24 Hours
Measured: Up to 6 weeks
Total Hours of Sleep per 24 Hours within 24 hours of intervention
Measured: Up to 6 weeks
Total Night Wake-ups within 24 hours of intervention
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start13 Feb 2025
- Primary completion10 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; FamilialStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Kinney Crandall, University of Michigan
- Investigators
- Amanda Crandall, PhD, Principal investigator, University of MichiganJulie Lumeng, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358729
- Sponsor's protocol ID
- HUM00239775
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2024
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers may consider sharing data but hesitate due to difficulties de-identifying data of small samples. Please contact the study team if you have questions.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-Pregnancy Weight Loss on Infant Sucking Behavior in Response to a Challenging Nipple
- ClinicalTrials.gov ID
- NCT06358729
- Acronym / sponsor ID
- HUM00239775
- Conditions
- Obesity; Familial, Pregnancy Related, Infant Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 11 Apr 2024 (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.
This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
Detailed description
The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nipple order 1 | Experimental | Behavioral: Typical Nipple, Behavioral: Challenging NippleFirst the typical nipple and then challenging nipple |
| Nipple order 2 | Experimental | Behavioral: Typical Nipple, Behavioral: Challenging NippleFirst the challenging nipple and then the typical nipple |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Typical NippleInfants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple. | Behavioural | Nipple order 1, Nipple order 2 |
| Challenging NippleInfants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery). | Behavioural | Nipple order 1, Nipple order 2 |
Primary outcome
Suck effect
Time frame: Up to 6 weeks
Sucking will be measured with the NFANT® Feeding Solution
7 secondary outcomes
Sucking pressure
Time frame: Up to 6 weeks
Sucking frequency
Time frame: Up to 6 weeks
Milk/Formula intake
Time frame: Up to 6 weeks
Milk/Formula consumption rate
Time frame: Up to 6 weeks
Number of Feedings Over 24 Hours
Time frame: Up to 6 weeks
Total Hours of Sleep per 24 Hours within 24 hours of intervention
Time frame: Up to 6 weeks
Total Night Wake-ups within 24 hours of intervention
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. The researchers may consider sharing data but hesitate due to difficulties de-identifying data of small samples. Please contact the study team if you have questions.
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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.
Amanda Crandall, PhD principal investigator
University of Michigan
Julie Lumeng, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Typical Nipple and Challenging Nipple in people with Obesity; Familial and Pregnancy Related, 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: finished, as of the sponsor's last update on 5 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Suck effect (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.