Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth
March 13, 2024 updated by: University of Colorado, Denver
Exploring the Fuel-mediated Programming of Neonatal Growth
The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.
Study Overview
Study Type
Observational
Enrollment (Estimated)
2821
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: Dana Dabelea, MD, PhD
- Phone Number: 303-724-4414
- Email: dana.dabelea@ucdenver.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Denver
-
Contact:
- Dana Dabelea, MD, PhD
- Phone Number: 303-724-4414
- Email: dana.dabelea@ucdenver.edu
-
-
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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants were recruited from prenatal obstetrics clinics at the University of Colorado Hospital outpatient pavilion.
Description
Inclusion Criteria:
- Pregnant women and infants
- Prior to 23 completed weeks of gestation
- Live in Colorado
Exclusion Criteria:
- Multiple gestation
Preexisting
- cancer
- psychiatric disease
- steroid-dependent asthma, or
- diabetes
- Previous premature delivery prior to 25 weeks gestation or fetal demise
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 |
Intervention / Treatment |
|---|---|
|
Pregnant women and their offspring
Ethnically diverse pregnant women and their offspring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass
Time Frame: Birth
|
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
|
Birth
|
|
Fat mass
Time Frame: 5 years
|
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass
Time Frame: 5 months
|
Body composition assessed via air displacement plethysmography to calculate fat mass and fat-free mass.
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dana Dabelea, MD, PhD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen CC, Harrall KK, Gilley SP, Perng W, Sauder KA, Scherzinger A, Shankar K, Sundaram SS, Glueck DH, Dabelea D. Body composition trajectories from birth to 5 years and hepatic fat in early childhood. Am J Clin Nutr. 2022 Oct 6;116(4):1010-1018. doi: 10.1093/ajcn/nqac168.
- Francis EC, Dabelea D, Boyle KE, Jansson T, Perng W. Maternal Diet Quality Is Associated with Placental Proteins in the Placental Insulin/Growth Factor, Environmental Stress, Inflammation, and mTOR Signaling Pathways: The Healthy Start ECHO Cohort. J Nutr. 2022 Mar 3;152(3):816-825. doi: 10.1093/jn/nxab403.
- Moore BF, Sauder KA, Starling AP, Hebert JR, Shivappa N, Ringham BM, Glueck DH, Dabelea D. Proinflammatory Diets during Pregnancy and Neonatal Adiposity in the Healthy Start Study. J Pediatr. 2018 Apr;195:121-127.e2. doi: 10.1016/j.jpeds.2017.10.030. Epub 2017 Dec 6.
- Perng W, Ringham BM, Glueck DH, Sauder KA, Starling AP, Belfort MB, Dabelea D. An observational cohort study of weight- and length-derived anthropometric indicators with body composition at birth and 5 mo: the Healthy Start study. Am J Clin Nutr. 2017 Aug;106(2):559-567. doi: 10.3945/ajcn.116.149617. Epub 2017 Jun 28.
- Boyle KE, Patinkin ZW, Shapiro AL, Baker PR 2nd, Dabelea D, Friedman JE. Mesenchymal Stem Cells From Infants Born to Obese Mothers Exhibit Greater Potential for Adipogenesis: The Healthy Start BabyBUMP Project. Diabetes. 2016 Mar;65(3):647-59. doi: 10.2337/db15-0849. Epub 2015 Dec 2.
- Starling AP, Brinton JT, Glueck DH, Shapiro AL, Harrod CS, Lynch AM, Siega-Riz AM, Dabelea D. Associations of maternal BMI and gestational weight gain with neonatal adiposity in the Healthy Start study. Am J Clin Nutr. 2015 Feb;101(2):302-9. doi: 10.3945/ajcn.114.094946. Epub 2014 Dec 3.
- Crume TL, Shapiro AL, Brinton JT, Glueck DH, Martinez M, Kohn M, Harrod C, Friedman JE, Dabelea D. Maternal fuels and metabolic measures during pregnancy and neonatal body composition: the healthy start study. J Clin Endocrinol Metab. 2015 Apr;100(4):1672-80. doi: 10.1210/jc.2014-2949. Epub 2015 Jan 9.
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
July 1, 2009
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
October 21, 2014
First Submitted That Met QC Criteria
October 22, 2014
First Posted (Estimated)
October 23, 2014
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-0563
- UL1TR001082 (U.S. NIH Grant/Contract)
- R01DK076648 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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