Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2011 by Stanford University
Sponsor:
Collaborator:
Lucile Packard Children's Hospital
Information provided by (Responsible Party):
Susan D Crowe, Stanford University
ClinicalTrials.gov Identifier:
NCT01469260
First received: November 8, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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 Intervention
Overweight
Obesity
Pregnancy
Other: Pedometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Excessive gestational weight gain [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Gestational weight gain greater than Institute of Medicine recommendations


Secondary Outcome Measures:
  • Postpartum weight [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
  • Weight at 1 year postpartum [ Time Frame: 1 year postpartum ] [ Designated as safety issue: No ]
  • Gestational diabetes [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 24-28 weeks gestation ] [ Designated as safety issue: No ]
  • Infant birth weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Hypertensive disorders of pregnancy [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • Neonatal intensive care unit admission or neonatal complications [ Time Frame: Up to 1 week after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Susan D Crowe, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01469260     History of Changes
Other Study ID Numbers: 22651
Study First Received: November 8, 2011
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Overweight
Obesity
Pregnancy
Weight gain
Pedometer
Exercise

Additional relevant MeSH terms:
Obesity
Overweight
Weight Gain
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014