NCT02125149

Brief Summary

The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

April 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 2, 2014

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

February 14, 2025

Status Verified

January 1, 2025

Enrollment Period

11.8 years

First QC Date

April 21, 2014

Last Update Submit

February 13, 2025

Conditions

PregnancyObese

Keywords

pregnancyobese

Outcome Measures

Primary Outcomes (1)

  • Risk of obesity in infants and children

    Birth weight, body fat, and metabolism will be evaluated during the first 2 years of life.

    2 years

Secondary Outcomes (2)

  • Maternal insulin sensitivity

    9 months

  • Maternal inflammation

    9 months

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Intervention

EXPERIMENTAL

Exercise intervention from 12 week gestation until delivery

Other: Exercise Intervention

Interventions

Exercise InterventionOTHER
Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30
  • \>18 years of age
  • Singleton pregnancy
  • Less than 12 weeks gestation
  • Sedentary
  • Conceived without assisted fertility treatments
  • Cleared by physician to exercise

You may not qualify if:

  • Women with pre-existing medical conditions as determined by the PI to affect the outcomes of interest
  • Women who are using recreational drugs, tobacco, or alcohol during pregnancy
  • Women with contraindications to exercise during pregnancy

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 (1)

  • 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.

    PMID: 32844207DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aline Andres, Ph.D

    UAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 29, 2014

Study Start

September 2, 2014

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

February 14, 2025

Record last verified: 2025-01

Locations

US(1)