Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01469260
• Other study ID #: 22651
• Status: Terminated
• Phase: N/A
• Start date: November 30, 2012
• Est. completion date: November 30, 2014

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: November 30, 2014
• Est. primary completion date: November 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Obstetrics Clinic	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Lucile Packard Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excessive gestational weight gain	Gestational weight gain greater than Institute of Medicine recommendations	At delivery
Secondary	Postpartum weight		6 weeks postpartum
Secondary	Weight at 1 year postpartum		1 year postpartum
Secondary	Gestational diabetes		During pregnancy
Secondary	Hemoglobin A1c		24-28 weeks gestation
Secondary	Infant birth weight		At delivery
Secondary	Mode of delivery		At delivery
Secondary	Hypertensive disorders of pregnancy		During pregnancy
Secondary	Neonatal intensive care unit admission or neonatal complications		Up to 1 week after delivery