Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The GLOWING Study: Growing Life, Optimizing Wellness 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281850
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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

Condition or disease
Healthy

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The GLOWING Study: Growing Life, Optimizing Wellness 2
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024



Primary Outcome Measures :
  1. Determine energy expenditure in children [ Time Frame: 2 years ]
    Using stable isotope techniques to determine energy expenditure

  2. Determine fat oxidation in children [ Time Frame: 2 years ]
    Using stable isotope techniques to determine fat oxidation


Biospecimen Retention:   Samples Without DNA
Urine collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A prospective longitudinal cohort of 150 dyads (pregnant women and offspring)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281850


Locations
Layout table for location information
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Additional Information:

Layout table for additonal information
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03281850    
Other Study ID Numbers: 206846
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No