Mother-Baby Study - Observational

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039878
• Other study ID #: HUM00227836
• Secondary ID: R01DK134979
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2023
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Alex Jeanpierre
• Phone: 734-647-1126
• Email: ajeanp[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days and older

Eligibility

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 is the mother's first live birth (i.e., first born) by maternal report

9. 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 age 1.0 month 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)

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Bonding-Evoked Oxytocin
Mother participates in bonding activity with infant at ages 1, 3, and 6 months
• Distress Relieving Effects of Sucrose
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 Sucrose
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-Social
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-Social
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)
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 36 months (infant age)