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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT05463120
Status
Enrolling By Invitation

Conditions

  • Puberty

Eligibility Criteria

Sex
ALL
Age
8 Years - 100 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Oct 10, 2022
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
566 participants (estimated)

Arms

  • Arm: IFED-2
    Children who participated in the IFED study as infants (2010-2014) and a parent/guardian will be enrolled in this follow-up study in childhood and followed for at least one year.

Primary Outcome Measure

To assess whether growth, timing of pubertal development, and hypothalamic-pituitary-gonadal (HPG) axis activity in childhood and adolescence are related to endogenous and exogenous endocrine-related factors during minipuberty of infancy. [ Time Frame: Various time points in childhood/adolescence (study enrollment, 6-month and 12-month follow-up visits currently planned). We anticipate that children will be 8-12 years of age at enrollment (2022) and followed prospectively. ]

Locations (2)

FacilityCityStateZIPSite coordinators
National Institute of Environmental Health Sciences (NIEHS)BethesdaMaryland20892-
Social & Scientific SystemsDurhamNorth Carolina27703-

Find similar trials in Bethesda, MD

By research site
National Institute of Environmental Health Sciences (NIEHS)· Bethesda, MDSocial & Scientific Systems· Durham, NC

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