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MinorEligibility criteria expanded, about 16 words
Study sites revised (2)
Study description expanded, about 3 words
Minor2 versionsRe-verified since Apr 29, 2026, no change to tracked fieldsv199-v200
NotablePrimary and study completion dates: Mar 1, 2026 to Mar 1, 2027v198
MinorRe-verified, no change to tracked fieldsv197
MinorStudy description shortened, about 8 wordsv196
Show 44 earlier versionsHide 44 earlier versions
Minor2 versionsRe-verified since May 24, 2025, no change to tracked fieldsv194-v195
MinorStudy Status, Eligibilityv193
NotablePrimary and study completion dates: Mar 1, 2025 to Mar 1, 2026v192
MinorRe-verified, no change to tracked fieldsv191
MinorStudy Status, Study Descriptionv190
Minor8 versionsRe-verified since May 8, 2024, no change to tracked fieldsv182-v189
NotablePrimary and study completion dates: Mar 1, 2024 to Mar 1, 2025v181
MinorRe-verified, no change to tracked fieldsv180
MinorStudy sites: 1 to 2v179
Minor4 versionsRe-verified since May 11, 2023, no change to tracked fieldsv175-v178
MinorStart date changed from estimate of Apr 6, 2023 to Oct 10, 2022v174
MinorStart date: Apr 4, 2023 to Apr 6, 2023v173
MinorStart date: Apr 3, 2023 to Apr 4, 2023v172
MinorStart date: Mar 31, 2023 to Apr 3, 2023v171
MinorStart date: Mar 30, 2023 to Mar 31, 2023v170
MinorStart date: Mar 28, 2023 to Mar 30, 2023v169
MinorStart date: Mar 27, 2023 to Mar 28, 2023v168
MinorStart date: Mar 24, 2023 to Mar 27, 2023v167
MinorStart date: Mar 22, 2023 to Mar 24, 2023v166
MinorStart date: Mar 21, 2023 to Mar 22, 2023v165
MinorStart date: Mar 20, 2023 to Mar 21, 2023v164
MinorStart date: Mar 19, 2023 to Mar 20, 2023v163
MinorStart date: Mar 16, 2023 to Mar 19, 2023v162
MinorStart date: Mar 15, 2023 to Mar 16, 2023v161
MinorStart date: Mar 14, 2023 to Mar 15, 2023v160
MinorStart date: Mar 13, 2023 to Mar 14, 2023v159
MinorStart date: Mar 12, 2023 to Mar 13, 2023v158
MinorStart date: Mar 9, 2023 to Mar 12, 2023v157
MinorStart date: Mar 8, 2023 to Mar 9, 2023v156
MinorStart date: Mar 7, 2023 to Mar 8, 2023v155
MinorStart date: Mar 6, 2023 to Mar 7, 2023v154
MinorStart date: Mar 5, 2023 to Mar 6, 2023v153
MinorStart date: Mar 2, 2023 to Mar 5, 2023v152
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.