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Minipuberty of Infancy and the Timing of Pubertal Development in Adolescence: a Follow-up of the Infant Feeding and Early Development (IFED) Cohort

NCT05463120 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 566

Last updated 2026-04-30

No results posted yet for this study

Summary

Background:

Earlier puberty is associated with adverse health throughout a person s life. The average age when puberty begins has been declining over the past decades in girls, and may also be declining in boys. The reasons for this shift are unknown.

Objective:

To determine whether internal (physical, hormonal) or external (feeding, environment) factors during infancy affect growth and the timing of puberty.

Eligibility:

Mothers (or other parent/guardian) and their children who completed the Infant Feeding and Early Development (IFED) study.

Design:

Participants will complete all activities at home for this natural history study.

Participant mothers will fill out two 15-minute questionnaires:

* One will be about themselves. They will answer questions about their body size in childhood, their puberty, and their pregnancies.
* The other will be about their child. They will answer questions about their child s puberty and lifestyle.

Child participants will fill out a questionnaire about their body changes during puberty. This will take 10 minutes.

Participants will be sent an electronic scale and a measuring tape. They will measure the child s weight, height, and waist and hip circumference. These numbers can be submitted online or by phone or mail.

Participants will receive a kit for collecting urine samples. Child participants will collect urine in a cup upon waking 4 days in a row. A special filter card is dipped in the cup then hung to dry. The dried cards will be mailed back.

Participants will allow researchers to access their child s medical records.

Questionnaires and body measurements will be repeated after 6 and 12 months. Urine sample collection will be repeated after 12 months.

All questionnaires can be done either online, by mail, or by phone on request.

Conditions

  • Puberty

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Dale P Sandler, Ph.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
8 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2027-03-01
Completion
2027-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463120 on ClinicalTrials.gov