Clinical trial NCT01131117: Fetal Programming of Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Pregnancy
Keywords: healthy
women
pregnancy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 320
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Child body composition
timeFrame: 24 months
Secondary outcomes:
measure: Child metabolism
timeFrame: 24 months
measure: Child development
timeFrame: 24 months
measure: Child dietary intake
timeFrame: 24 months
measure: Placenta gene expression
timeFrame: 9 months
measure: Placenta protein content
timeFrame: 9 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Aline Andres, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.