NCT01131117

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 14, 2025

Status Verified

January 1, 2025

Enrollment Period

8.3 years

First QC Date

May 25, 2010

Last Update Submit

February 13, 2025

Conditions

Keywords

healthywomenpregnancy

Outcome Measures

Primary Outcomes (1)

  • Child body composition

    lean and fat mass of the child

    24 months

Secondary Outcomes (5)

  • Child metabolism

    24 months

  • Child development

    24 months

  • Child dietary intake

    24 months

  • Placenta gene expression

    9 months

  • Placenta protein content

    9 months

Study Arms (1)

Pregnant women

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy women

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (11)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, human milk, placenta, cord blood and umbilical cord may be collected from study participants.

Study Officials

  • Aline Andres, PhD, RD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 26, 2010

Study Start

April 2, 2010

Primary Completion

August 1, 2018

Study Completion

November 1, 2024

Last Updated

February 14, 2025

Record last verified: 2025-01

Locations