Pedometer Use to Prevent Excessive Pregnancy Weight Gain... | NCT01469260

Studies
Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women

NCT01469260

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Sep 21, 2021Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Overweight
Obesity
Pregnancy

Interventions

Pedometer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

resources

Expanded Access Info

Start Date

Nov 30, 2012Actual

Primary Completion Date

Nov 30, 2013Actual

Completion Date

Nov 30, 2014Actual

First Submitted Date

Nov 8, 2011

First Submission Date that Met QC Criteria

Nov 8, 2011

First Posted Date

Nov 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Name	Class
Lucile Packard Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Excessive gestational weight gain	Gestational weight gain greater than Institute of Medicine recommendations	At delivery

Secondary Outcomes

Measure	Description	Time Frame
Postpartum weight		6 weeks postpartum
Weight at 1 year postpartum		1 year postpartum
Gestational diabetes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Crowe, MD	Stanford University	Principal Investigator
Joyce Sung, MD	Stanford University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lucile Packard Children's Hospital Obstetrics Clinic		Palo Alto	California	94304	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity
D015430	Weight Gain
D009043	Motor Activity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided