Mother-Baby Study - Observational

What Was Tested

The trial (not phased) is built around Oxytocin.

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.

It had 1 arm (groups): Mother-Infant Dyad (experimental).

The registry classes the interventions as behavioral.

More on the Plan

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.

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.

Who Took Part

The registry lists 250 actual participants took part.

It was open to people of any sex aged from 0 Days with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Provision of signed and dated informed consent form by mother for herself and infant. Stated willingness by mother to comply with all study procedures and availability for the duration of the study. Infant gestational age 37.0 - 42.0 weeks based on maternal report of due date and child's birth date. Infant birth weight by maternal report appropriate (≥ 3rd percentile and ≤ 97th percentile) for gestational age and sex based on US Natality Data set. 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).

The full record lists 19 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-12-21 with completion listed for 2029-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

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

What This Means in Plain Language

Put simply, this is a not phased trial of Oxytocin in 250 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.