Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

NCT ID: NCT01469260

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Obesity Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine care

ACOG Exercise in Pregnancy pamphlet

Group Type NO_INTERVENTION

No interventions assigned to this group

Pedometer

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

Group Type EXPERIMENTAL

Pedometer

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pedometer

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lucile Packard Children's Hospital

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Susan D Crowe

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susan Crowe, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Joyce Sung, MD

Role: STUDY_CHAIR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lucile Packard Children's Hospital Obstetrics Clinic

Palo Alto, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22651

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.