Healthy Start: Exploring the Fuel-mediated Programming of Neonatal Growth

NCT ID: NCT02273297

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women and their offspring

Ethnically diverse pregnant women and their offspring

Maternal factors

Intervention Type OTHER

Interventions

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Maternal factors

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana Dabelea, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dana Dabelea, MD, PhD

Role: CONTACT

303-724-4414

Facility Contacts

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Dana Dabelea, MD, PhD

Role: primary

303-724-4414

References

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Buck KE, Dhaliwal SK, Dabelea D, Perng W. Association of maternal psychosocial stress with newborn body composition in the Healthy Start study. J Dev Orig Health Dis. 2023 Oct;14(5):576-583. doi: 10.1017/S2040174423000223. Epub 2023 Sep 11.

Reference Type DERIVED
PMID: 37694587 (View on PubMed)

Dhaliwal SK, Dabelea D, Lee-Winn AE, Crume T, Wilkening G, Perng W. Maternal psychosocial stress during pregnancy and offspring neurobehavioral outcomes during early childhood in the Healthy Start Study. Ann Epidemiol. 2023 Oct;86:16-24.e3. doi: 10.1016/j.annepidem.2023.06.001. Epub 2023 Jun 14.

Reference Type DERIVED
PMID: 37321280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36055960 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34850052 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29217099 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28659296 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26631736 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25646327 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25574704 (View on PubMed)

Other Identifiers

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R01DK076648

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0563

Identifier Type: -

Identifier Source: org_study_id

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