Beginnings Study Follow up

This study will help us learn more about how early infant diet may influence child's growth and development at age 14.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is to follow the infants that were enrolled in Beginnings study which purpose was to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast milk, milk based formula, or soy based formula during their first year of life up to age 6. This study will call back those children when they turn 14 to compare growth, sexual maturation, and development between the three diets.

Study Type

Observational

Enrollment (Estimated)

1173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Former Beginnings participants at age 14

Description

Inclusion Criteria:

  • Beginnings study former participants

Exclusion Criteria:

  • Dropped participants for medical diagnosis or medical conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast milk fed
Fed primarily breast fed as an infant
Milk based formula fed
Fed primarily milk based formula as an infant
Soy based formula fed
Fed primarily soy based formula as an infant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth and development
Time Frame: 14 years
Will be determined with body composition equipment
14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2017

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 206291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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