The Expecting Study

February 1, 2024 updated by: Arkansas Children's Hospital Research Institute

Prenatal Physical Activity Intervention

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Conway, Arkansas, United States, 72034
        • Tonja C Nolen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard of care
Experimental: Intervention
Exercise intervention from 12 week gestation until delivery
Other: Exercise Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of obesity in infants and children
Time Frame: 2 years
Birth weight, body fat, and metabolism will be evaluated during the first 2 years of life.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal insulin sensitivity
Time Frame: 9 months
Fasted blood samples will be analyzed to assess glucose and insulin.
9 months
Maternal inflammation
Time Frame: 9 months
Markers of inflammation will be investigated in fasted serum samples.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Aline Andres, Ph.D, UAMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2014

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimated)

April 29, 2014

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202954

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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