- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03108014
Beginnings Study Follow up
December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
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
- Name: Tonja C Nolen, MS
- Phone Number: 501-364-2853
- Email: nolentc@archildrens.org
Study Contact Backup
- Name: Audrey Martinez, MS, RD, LD
- Phone Number: 501-364-3309
- Email: acncstudies@archildrens.org
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- Recruiting
- Arkansas Children's Nutrition Center
-
Contact:
- Audrey Martinez, MS, RD, LD
- Phone Number: 501-364-3309
- Email: acncstudies@archildrens.org
-
Contact:
- Tonja C Nolen, MS
- Phone Number: 501-364-3309
- Email: acncstudies@archildrens.org
-
-
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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