search
Back to results

Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

Primary Purpose

Overweight, Obesity, Pregnancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedometer
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Overweight, Obesity, Pregnancy, Weight gain, Pedometer, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lucile Packard Children's Hospital Obstetrics Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine care

Pedometer

Arm Description

ACOG Exercise in Pregnancy pamphlet

ACOG Exercise in Pregnancy pamphlet, pedometer use, ultimate goal of 10,000 steps per day

Outcomes

Primary Outcome Measures

Excessive gestational weight gain
Gestational weight gain greater than Institute of Medicine recommendations

Secondary Outcome Measures

Postpartum weight
Weight at 1 year postpartum
Gestational diabetes
Hemoglobin A1c
Infant birth weight
Mode of delivery
Hypertensive disorders of pregnancy
Neonatal intensive care unit admission or neonatal complications

Full Information

First Posted
November 8, 2011
Last Updated
September 20, 2021
Sponsor
Stanford University
Collaborators
Lucile Packard Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01469260
Brief Title
Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women
Official Title
Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
resources
Study Start Date
November 30, 2012 (Actual)
Primary Completion Date
November 30, 2013 (Actual)
Study Completion Date
November 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Lucile Packard Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Pregnancy
Keywords
Overweight, Obesity, Pregnancy, Weight gain, Pedometer, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine care
Arm Type
No Intervention
Arm Description
ACOG Exercise in Pregnancy pamphlet
Arm Title
Pedometer
Arm Type
Experimental
Arm Description
ACOG Exercise in Pregnancy pamphlet, pedometer use, ultimate goal of 10,000 steps per day
Intervention Type
Other
Intervention Name(s)
Pedometer
Intervention Description
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 Measure Information:
Title
Excessive gestational weight gain
Description
Gestational weight gain greater than Institute of Medicine recommendations
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Postpartum weight
Time Frame
6 weeks postpartum
Title
Weight at 1 year postpartum
Time Frame
1 year postpartum
Title
Gestational diabetes
Time Frame
During pregnancy
Title
Hemoglobin A1c
Time Frame
24-28 weeks gestation
Title
Infant birth weight
Time Frame
At delivery
Title
Mode of delivery
Time Frame
At delivery
Title
Hypertensive disorders of pregnancy
Time Frame
During pregnancy
Title
Neonatal intensive care unit admission or neonatal complications
Time Frame
Up to 1 week after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Crowe, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joyce Sung, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Lucile Packard Children's Hospital Obstetrics Clinic
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

We'll reach out to this number within 24 hrs