NCT02516865

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

May 13, 2015

Last Update Submit

August 5, 2015

Conditions

Body Weight

Keywords

postpartumphysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in baseline body weight at 12-months postpartum.

    Baseline and 12 months

Study Arms (3)

Group 1

EXPERIMENTAL
Device: Fitbit activity tracker

Group 2

EXPERIMENTAL
Device: Fitbit activity trackerDevice: Ankle weights

Group 3

NO INTERVENTION

Interventions

Fitbit activity trackerDEVICE

Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.

Group 1Group 2
Ankle weightsDEVICE

Worn during typical daily activities.

Group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • months postpartum women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

RECRUITING

MeSH Terms

Conditions

Body WeightMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Reena Oza-Frank, PhD

CONTACT

614-355-6625reena.oza-frank@nationwidechildrens.org

Maxine Mendelson

CONTACT

614-355-6685maxine.mendelson@nationwidechildrens.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Coordinator

Study Record Dates

First Submitted

May 13, 2015

First Posted

August 6, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

US(1)