Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

September 20, 2021 updated by: Susan D Crowe, Stanford University

Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women

The purpose of this study is to evaluate pedometer use by overweight women during pregnancy. The study will show if a pedometer will help women to limit weight gain during pregnancy. It will also show if it there are other benefits such as decreased diabetes, decreased high blood pressure, decreased rates of cesarean section, and decreased complications for the baby.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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 Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital Obstetrics Clinic

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 years or older
  • Pregnant
  • Less than 16 weeks gestation
  • Body mass index 25 or greater at first prenatal visit

Exclusion Criteria:

  • History of spontaneous preterm delivery between 20-32 weeks gestation
  • Medical contraindication to exercise or walking 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine care
ACOG Exercise in Pregnancy pamphlet
Experimental: Pedometer
ACOG Exercise in Pregnancy pamphlet, pedometer use, ultimate goal of 10,000 steps per day
Other: Pedometer
Pedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excessive gestational weight gain
Time Frame: At delivery
Gestational weight gain greater than Institute of Medicine recommendations
At delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mode of delivery
Time Frame: At delivery
At delivery
Postpartum weight
Time Frame: 6 weeks postpartum
6 weeks postpartum
Weight at 1 year postpartum
Time Frame: 1 year postpartum
1 year postpartum
Gestational diabetes
Time Frame: During pregnancy
During pregnancy
Hemoglobin A1c
Time Frame: 24-28 weeks gestation
24-28 weeks gestation
Infant birth weight
Time Frame: At delivery
At delivery
Hypertensive disorders of pregnancy
Time Frame: During pregnancy
During pregnancy
Neonatal intensive care unit admission or neonatal complications
Time Frame: Up to 1 week after delivery
Up to 1 week after delivery

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

Lucile Packard Children's Hospital

Investigators

  • Principal Investigator: Susan Crowe, MD, Stanford University
  • Study Chair: Joyce Sung, MD, Stanford University

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)

November 30, 2012

Primary Completion (Actual)

November 30, 2013

Study Completion (Actual)

November 30, 2014

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22651

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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