The GLOWING Study: Growing Life, Optimizing Wellness 2

Sponsor
Arkansas Children's Hospital Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03281850
Collaborator
(none)
212
1
87.6
2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study follows people who are healthy and less than 36 weeks pregnant to see how the mother's health can impact their child's growth and development. Up to 300 people including the mother and their future child will be a part of this study. The study will follow the child until they are two years of age.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    212 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The GLOWING Study: Growing Life, Optimizing Wellness 2
    Actual Study Start Date :
    Sep 11, 2017
    Anticipated Primary Completion Date :
    Dec 30, 2024
    Anticipated Study Completion Date :
    Dec 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Determine energy expenditure in children [2 years]

      Using stable isotope techniques to determine energy expenditure

    2. Determine fat oxidation in children [2 years]

      Using stable isotope techniques to determine fat oxidation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Pre-pregnancy BMI 18.5-45

    • Singleton pregnancy

    • at least 18 years of age

    • conceived without assisted fertility treatments

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Children's Nutrition Center Little Rock Arkansas United States 72202

    Sponsors and Collaborators

    • Arkansas Children's Hospital Research Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arkansas Children's Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT03281850
    Other Study ID Numbers:
    • 206846
    First Posted:
    Sep 13, 2017
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 5, 2022