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Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

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ClinicalTrials.gov Identifier: NCT01469260
Recruitment Status : Unknown
Verified November 2011 by Susan D Crowe, Stanford University.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2011
Last Update Posted : November 10, 2011
Sponsor:
Collaborator:
Lucile Packard Children's Hospital
Information provided by (Responsible Party):
Susan D Crowe, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment
Overweight Obesity Pregnancy Other: Pedometer

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women
Study Start Date : November 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Routine care
ACOG Exercise in Pregnancy pamphlet
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
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



Primary Outcome Measures :
  1. Excessive gestational weight gain [ Time Frame: At delivery ]
    Gestational weight gain greater than Institute of Medicine recommendations


Secondary Outcome Measures :
  1. Postpartum weight [ Time Frame: 6 weeks postpartum ]
  2. Weight at 1 year postpartum [ Time Frame: 1 year postpartum ]
  3. Gestational diabetes [ Time Frame: During pregnancy ]
  4. Hemoglobin A1c [ Time Frame: 24-28 weeks gestation ]
  5. Infant birth weight [ Time Frame: At delivery ]
  6. Mode of delivery [ Time Frame: At delivery ]
  7. Hypertensive disorders of pregnancy [ Time Frame: During pregnancy ]
  8. Neonatal intensive care unit admission or neonatal complications [ Time Frame: Up to 1 week after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469260


Contacts
Contact: Susan Crowe, MD 650-498-4069 scrowe@stanford.edu
Contact: Joyce Sung, MD 650-725-8623 joycefu@stanford.edu

Locations
United States, California
Lucile Packard Children's Hospital Obstetrics Clinic Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Susan Crowe, MD       scrowe@stanford.edu   
Principal Investigator: Susan Crowe, MD         
Sponsors and Collaborators
Stanford University
Lucile Packard Children's Hospital
Investigators
Principal Investigator: Susan Crowe, MD Stanford University
Study Chair: Joyce Sung, MD Stanford University

Responsible Party: Susan D Crowe, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01469260     History of Changes
Other Study ID Numbers: 22651
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by Susan D Crowe, Stanford University:
Overweight
Obesity
Pregnancy
Weight gain
Pedometer
Exercise

Additional relevant MeSH terms:
Overweight
Weight Gain
Body Weight
Signs and Symptoms
Body Weight Changes