NCT03281850

Brief Summary

This study will help us learn more about how maternal health can influence child health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

September 7, 2017

Last Update Submit

February 13, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Determine energy expenditure in children

    Using stable isotope techniques to determine energy expenditure

    2 years

  • Determine fat oxidation in children

    Using stable isotope techniques to determine fat oxidation

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A prospective longitudinal cohort of 150 dyads (pregnant women and offspring)

You may qualify if:

  • Pre-pregnancy BMI 18.5-45
  • Singleton pregnancy
  • at least 18 years of age
  • conceived without assisted fertility treatments

You may not qualify if:

  • Preexisting medical conditions (e.g. DM, GDM, CRF, HTN, pre-eclampsia or eclampsia, malignancies, seizure disorder, lupus, serious psychiatric disorders)
  • sexually transmitted diseases
  • medications during pregnancy known to influence fetal growth
  • smoking, alcohol drinking or drug use during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

  • Diaz EC, Williams DK, Cotter M, Sims CR, Wolfe RR, Andres A, Borsheim E. Breastfeeding duration modifies the association between maternal weight status and offspring dietary palmitate oxidation. Am J Clin Nutr. 2022 Aug 4;116(2):404-414. doi: 10.1093/ajcn/nqac097.

    PMID: 35404455DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine collected

Study Officials

  • Aline Andres, PhD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 13, 2017

Study Start

September 11, 2017

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

US(1)