Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

• Sponsor: Stanford University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01469260
• Collaborator: Lucile Packard Children's Hospital (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity; Pregnancy	Other: Pedometer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 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
• Actual Study Start Date: Nov 30, 2012
• Actual Primary Completion Date: Nov 30, 2013
• Actual Study Completion Date: Nov 30, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Excessive gestational weight gain [At delivery]

   Gestational weight gain greater than Institute of Medicine recommendations

Secondary Outcome Measures

1. Postpartum weight [6 weeks postpartum]

2. Weight at 1 year postpartum [1 year postpartum]

3. Gestational diabetes [During pregnancy]

4. Hemoglobin A1c [24-28 weeks gestation]

5. Infant birth weight [At delivery]

6. Mode of delivery [At delivery]

7. Hypertensive disorders of pregnancy [During pregnancy]

8. Neonatal intensive care unit admission or neonatal complications [Up to 1 week after delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Lucile Packard Children's Hospital Obstetrics Clinic	Palo Alto	California	United States	94304

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susan D Crowe, Clinical Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT01469260
• Other Study ID Numbers: 22651
• First Posted: Nov 10, 2011
• Last Update Posted: Sep 21, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Susan D Crowe, Clinical Assistant Professor, Stanford University: Overweight; Obesity; Pregnancy; Weight gain; Pedometer; Exercise
• Additional relevant MeSH terms: Overweight; Weight Gain

Study Results

No Results Posted as of Sep 21, 2021