Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

NCT01469260 | Terminated

• 1 other identifier: 22651
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Pregnancy

Keywords

Overweight; Obesity; Pregnancy; Weight gain; Pedometer; Exercise

Outcome Measures

Primary Outcomes (1)

• Excessive gestational weight gain

  Gestational weight gain greater than Institute of Medicine recommendations

  At delivery

Secondary Outcomes (8)

• Postpartum weight

  6 weeks postpartum

• Weight at 1 year postpartum

  1 year postpartum

• Gestational diabetes

  During pregnancy

• Hemoglobin A1c

  24-28 weeks gestation

• Infant birth weight

  At delivery

Study Arms (2)

Routine care

NO INTERVENTION

ACOG Exercise in Pregnancy pamphlet

Pedometer

EXPERIMENTAL

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

Other: Pedometer

Interventions

Pedometer OTHER

Pedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise

Pedometer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Pregnant
• Less than 16 weeks gestation
• Body mass index 25 or greater at first prenatal visit

You may not qualify if:

• History of spontaneous preterm delivery between 20-32 weeks gestation
• Medical contraindication to exercise or walking during pregnancy

Sponsors & Collaborators

• Stanford University: lead
• Lucile Packard Children's Hospital: collaborator

Study Sites (1)

Lucile Packard Children's Hospital Obstetrics Clinic

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Gain; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Susan Crowe, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Joyce Sung, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: November 30, 2012
• Primary Completion: November 30, 2013
• Study Completion: November 30, 2014
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)