Practical Approaches to Exercise in Moms | NCT02516865

Studies
Practical Approaches to Exercise in Moms

NCT02516865

Sponsor

Maxine Mendelson

Status

Unknown status

Last Update Posted

Aug 6, 2015Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Body Weight

Interventions

Fitbit activity tracker
Ankle weights

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

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2016Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

May 13, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 6, 2015Estimated

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

Aug 5, 2015

Last Update Posted Date

Aug 6, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maxine Mendelson, Clinical Research Coordinator, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Maxine MendelsonOTHER

Collaborators

Not provided

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

This project aims to test the feasibility of a practical physical activity intervention for postpartum women, incorporating the use of body weights worn during typical daily activities.

Detailed Description

We are piloting a 3-arm, unblinded, randomized controlled trial in postpartum women; with 10 participants in each study group. Women will be recruited at 2-6 months postpartum, with the intervention lasting through 12 months postpartum. Data collection will include:1) Physical activity; 2) Maternal body composition; 3) Questionnaires to assess:motivation to adopt healthy behaviors, body attitudes, infant feeding practices; 4) Process evaluation to assess: likes and dislikes about the intervention program, suggestions for improving the intervention, reasons for leaving the study. The proposed study time period is 6 months for study recruitment, 18 months to carry out the study, and 6 months for data analysis (total 2 years).

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1	Experimental	Device: Fitbit activity tracker
Group 2	Experimental	Device: Fitbit activity tracker Device: Ankle weights
Group 3	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fitbit activity tracker	Device	Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in baseline body weight at 12-months postpartum.		Baseline and 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

2-6 months postpartum women

Exclusion Criteria:

Premature birth
History of serious illness
Medically incapable of low-intensity exercise
Currently taking medications that cause weight loss

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

Name	Role	Phone	Extension	Email
Reena Oza-Frank, PhD	Contact	614-355-6625		reena.oza-frank@nationwidechildrens.org
Maxine Mendelson	Contact	614-355-6685		maxine.mendelson@nationwidechildrens.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital	Recruiting	Columbus	Ohio	43215	United States

Condition Browse Module

MeSH Terms

ID	Term
D001835	Body Weight
D009043	Motor Activity

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided