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CompletedNCT01131117Updated Sep 25, 2026

Fetal Programming of Obesity

An observational study in Healthy and Pregnancy, sponsored by Arkansas Children's Hospital Research Institute. Completed at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Arkansas Children's Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
21 Years and older
Sex
Female
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Study summary

The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

Read the detailed description

The purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. We plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time PCR; and 5) focused on appropriate-for-gestational age (AGA) infants (the majority of infants born from normal and overweight mothers).Accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.

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Conditions studied

  • Healthy
  • Pregnancy

Keywords

  • healthy
  • women
  • pregnancy
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In context

Lead sponsor

Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy women

Inclusion criteria

  • healthy
  • 21 years of age or older
  • second pregnancy, singleton
  • conceived without fertility treatments

Exclusion criteria

Exclusion Criteria:

  • Preexisting medical conditions
  • Sexually transmitted diseases
  • Medical complications during pregnancy
  • Medications during pregnancy known to influence fetal growth
  • Smoking, alcohol drinking
  • Excessive physical activity level which could affect the outcome of interest.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Pregnant women
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What researchers measure

Primary outcomes

  1. Child body composition

    lean and fat mass of the child

    Time frame: 24 months

Secondary outcomes

  1. Child metabolism

    monitor with a metabolic cart

    Time frame: 24 months

  2. Child development

    Monitored from 2wks up to 24 months

    Time frame: 24 months

  3. Child dietary intake

    Food records for each visit will be obtained

    Time frame: 24 months

  4. Placenta gene expression

    via gene microarray and real time PCR

    Time frame: 9 months

  5. Placenta protein content

    via gene microarray and real time PCR

    Time frame: 9 months

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Study locations

1 site
  • Arkansas Children's Nutrition Center
    Little Rock, Arkansas 72202, United States
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References and documents

Publications

  • Crimmins MR, Hand M, Samuel H, Bellando J, Sims CR, Andres A, Sobik S. The Impact of Excessive Weight on Breastfeeding Intention, Initiation, and Duration. Breastfeed Med. 2023 Sep;18(9):688-695. doi: 10.1089/bfm.2023.0072. PubMed 37729033 ↗
  • Gilley SP, Ruebel ML, Sims C, Zhong Y, Turner D, Lan RS, Pack LM, Piccolo BD, Chintapalli SV, Abraham A, Bode L, Andres A, Shankar K. Associations between maternal obesity and offspring gut microbiome in the first year of life. Pediatr Obes. 2022 Sep;17(9):e12921. doi: 10.1111/ijpo.12921. Epub 2022 Apr 27. PubMed 35478493 ↗
  • Kracht CL, Redman LM, Casey PH, Krukowski RA, Andres A. Association between Home Environment in Infancy and Child Movement Behaviors. Child Obes. 2021 Mar;17(2):100-109. doi: 10.1089/chi.2020.0319. Epub 2021 Jan 20. PubMed 33471594 ↗
  • Saben JL, Sims CR, Piccolo BD, Andres A. Maternal adiposity alters the human milk metabolome: associations between nonglucose monosaccharides and infant adiposity. Am J Clin Nutr. 2020 Nov 11;112(5):1228-1239. doi: 10.1093/ajcn/nqaa216. PubMed 32844207 ↗
  • Sims CR, Lipsmeyer ME, Turner DE, Andres A. Human milk composition differs by maternal BMI in the first 9 months postpartum. Am J Clin Nutr. 2020 Sep 1;112(3):548-557. doi: 10.1093/ajcn/nqaa098. PubMed 32401302 ↗
  • Allman BR, Diaz EC, Andres A, Borsheim E. Divergent Changes in Serum Branched-Chain Amino Acid Concentrations and Estimates of Insulin Resistance throughout Gestation in Healthy Women. J Nutr. 2020 Jul 1;150(7):1757-1764. doi: 10.1093/jn/nxaa096. PubMed 32275314 ↗
  • Diaz EC, Borsheim E, Shankar K, Cleves MA, Andres A. Prepregnancy Fat Free Mass and Associations to Glucose Metabolism Before and During Pregnancy. J Clin Endocrinol Metab. 2019 May 1;104(5):1394-1403. doi: 10.1210/jc.2018-01381. PubMed 30496579 ↗
  • Porter H, West DS, Cleves MA, Saylors ME, Andres A, Krukowski RA. Association Between Household Food Environment and Excessive Gestational Weight Gain. J Womens Health (Larchmt). 2018 Aug;27(8):1064-1070. doi: 10.1089/jwh.2017.6552. Epub 2018 Apr 5. PubMed 29620954 ↗
  • Krukowski RA, West DS, DiCarlo M, Cleves MA, Saylors ME, Andres A. Association of Gestational Weight Gain Expectations and Advice on Actual Weight Gain. Obstet Gynecol. 2017 Jan;129(1):76-82. doi: 10.1097/AOG.0000000000001780. PubMed 27926649 ↗
  • Krukowski RA, West DS, DiCarlo M, Shankar K, Cleves MA, Saylors ME, Andres A. Are early first trimester weights valid proxies for preconception weight? BMC Pregnancy Childbirth. 2016 Nov 21;16(1):357. doi: 10.1186/s12884-016-1159-6. PubMed 27871260 ↗
  • Krukowski RA, West D, DiCarlo M, Shankar K, Cleves MA, Tedford E, Andres A. A Behavioral Intervention to Reduce Excessive Gestational Weight Gain. Matern Child Health J. 2017 Mar;21(3):485-491. doi: 10.1007/s10995-016-2127-5. PubMed 27449652 ↗
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Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date, oversight details, references and index terms
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 4 other changes: verification date, oversight details, references and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT01131117
Lead sponsor
Arkansas Children's Hospital Research Institute
Responsible party
Sponsor
First posted
May 26, 2010
Start date
Apr 2, 2010
Primary completion
Aug 2018
Completion
Nov 2024
Last update
Sep 25, 2026

Study contacts

Aline Andres, PhD, RD
principal investigator · Arkansas Children's Nutrition Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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