Body WeightPhase 1PE MomsNCT02516865
Practical Approaches to Exercise in Moms
A Phase 1 study testing Fitbit activity tracker and Ankle weights in people with Body Weight, run by Maxine Mendelson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- What is being tested?
- Fitbit activity tracker and Ankle weights
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 2-6 months postpartum women
Who cannot join
- Premature birth
- History of serious illness
- Medically incapable of low-intensity exercise
- Currently taking medications that cause weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43215
Maxine Mendelson, 614-355-6685, maxine.mendelson@nationwidechildrens.org
About this study
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.
Read the 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).
- Conditions
- Body Weight
- Being tested
- Fitbit activity tracker, Ankle weights
- Keywords
- postpartum, physical activity
- Medical subject headings
- Body Weight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit activity trackerDevice
Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.
Ankle weightsDevice
Worn during typical daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Device: Fitbit activity tracker |
| Group 2 | Experimental | Not described Receives: Device: Fitbit activity tracker; Device: Ankle weights |
| Group 3 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline body weight at 12-months postpartum.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxine Mendelson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maxine Mendelson, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516865
- Sponsor's protocol ID
- IRB15-00117
- Acronym
- PE Moms
- Status last verified
- Aug 2015
- First submitted
- 13 May 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Approaches to Exercise in Moms
- ClinicalTrials.gov ID
- NCT02516865
- Acronym / sponsor ID
- PE Moms / IRB15-00117
- Conditions
- Body Weight
- Keywords
- postpartum, physical activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxine MendelsonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Fitbit activity tracker |
| Group 2 | Experimental | Device: Fitbit activity tracker, Device: Ankle weights |
| Group 3 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 2-6 months postpartum women
Key exclusion criteria (4 listed)
- Premature birth
- History of serious illness
- Medically incapable of low-intensity exercise
- Currently taking medications that cause weight loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit activity trackerTracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement. | Device | Group 1, Group 2 |
| Ankle weightsWorn during typical daily activities. | Device | Group 2 |
Primary outcome
Change in baseline body weight at 12-months postpartum.
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fitbit activity tracker and Ankle weights in people with Body Weight, run by Maxine Mendelson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reena Oza-Frank, PhD (614-355-6625, reena.oza-frank@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline body weight at 12-months postpartum. (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.