Practical Approaches to Exercise in Moms

NCT ID: NCT02516865

Last Updated: 2015-08-06

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-04-30

Brief Summary

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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

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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).

Conditions

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Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type EXPERIMENTAL

Fitbit activity tracker

Intervention Type DEVICE

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

Group 2

Group Type EXPERIMENTAL

Fitbit activity tracker

Intervention Type DEVICE

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

Ankle weights

Intervention Type DEVICE

Worn during typical daily activities.

Group 3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fitbit activity tracker

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

Intervention Type DEVICE

Ankle weights

Worn during typical daily activities.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maxine Mendelson

OTHER

Sponsor Role lead

Responsible Party

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Maxine Mendelson

Clinical Research Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Reena Oza-Frank, PhD

Role: CONTACT

614-355-6625

Maxine Mendelson

Role: CONTACT

614-355-6685

Facility Contacts

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Maxine Mendelson

Role: primary

614-355-6685

Other Identifiers

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IRB15-00117

Identifier Type: -

Identifier Source: org_study_id

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