OverweightNCT01469260
Pedometer Use to Prevent Excessive Pregnancy Weight Gain in Overweight Women
A study testing Pedometer in people with Overweight and Obesity, run by Stanford University at 1 site in United States.
Trial 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. 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
- Overweight, Obesity, Pregnancy
- What is being tested?
- Pedometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2012to 30 Nov 2014
- Phase
- Interventional
- 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
- Age 18 years or older
- Pregnant
- Less than 16 weeks gestation
- Body mass index 25 or greater at first prenatal visit
Who cannot join
- History of spontaneous preterm delivery between 20-32 weeks gestation
- Medical contraindication to exercise or walking during pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Obstetrics Clinic
Palo Alto, California, 94304
About this study
Official title: Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women
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.
- Conditions
- Overweight, Obesity, Pregnancy
- Being tested
- Pedometer
- Keywords
- Overweight, Obesity, Pregnancy, Weight gain, Pedometer, Exercise
- Medical subject headings
- Overweight, Obesity, Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedometerOther
Pedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive gestational weight gain
Gestational weight gain greater than Institute of Medicine recommendations
Measured: At delivery
Secondary outcomes (8)
Postpartum weight
Measured: 6 weeks postpartum
Weight at 1 year postpartum
Measured: 1 year postpartum
Gestational diabetes
Measured: During pregnancy
Hemoglobin A1c
Measured: 24-28 weeks gestation
Infant birth weight
Measured: At delivery
Mode of delivery
Measured: At delivery
Hypertensive disorders of pregnancy
Measured: During pregnancy
Neonatal intensive care unit admission or neonatal complications
Measured: Up to 1 week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study start30 Nov 2012
- Primary completion30 Nov 2013
- Study completion30 Nov 2014
Why it stopped: resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Lucile Packard Children's Hospital
- Responsible party
- Principal investigator, Susan D Crowe, Stanford University
- Investigators
- Susan Crowe, MD, Principal investigator, Stanford UniversityJoyce Sung, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469260
- Sponsor's protocol ID
- 22651
- Status last verified
- Sep 2021
- First submitted
- 8 Nov 2011
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Pedometer Use to Prevent Excessive Gestational Weight Gain in Overweight/Obese Women
- ClinicalTrials.gov ID
- NCT01469260
- Acronym / sponsor ID
- 22651
- Conditions
- Overweight, Obesity, Pregnancy
- Keywords
- Overweight, Obesity, Pregnancy, Weight gain, Pedometer, Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: resources
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Lucile Packard Children's Hospital
- Study start
- 30 Nov 2012 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 10 Nov 2011 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | No intervention | –ACOG Exercise in Pregnancy pamphlet |
| Pedometer | Experimental | Other: PedometerACOG Exercise in Pregnancy pamphlet, pedometer use, ultimate goal of 10,000 steps per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Pregnant
- Less than 16 weeks gestation
- Body mass index 25 or greater at first prenatal visit
Key exclusion criteria (2 listed)
- History of spontaneous preterm delivery between 20-32 weeks gestation
- Medical contraindication to exercise or walking during pregnancy
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 |
|---|---|---|
| PedometerPedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise | Other | Pedometer |
Primary outcome
Excessive gestational weight gain
Time frame: At delivery
Gestational weight gain greater than Institute of Medicine recommendations
8 secondary outcomes
Postpartum weight
Time frame: 6 weeks postpartum
Weight at 1 year postpartum
Time frame: 1 year postpartum
Gestational diabetes
Time frame: During pregnancy
Hemoglobin A1c
Time frame: 24-28 weeks gestation
Infant birth weight
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Hypertensive disorders of pregnancy
Time frame: During pregnancy
Neonatal intensive care unit admission or neonatal complications
Time frame: Up to 1 week after delivery
Results and safety
The study was stopped early (reason given: resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
Susan Crowe, MD principal investigator
Stanford University
Joyce Sung, MD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer in people with Overweight and Obesity, run by Stanford University 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 21 Sep 2021. 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.
Are results available for this study?
The study was stopped early (reason given: resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excessive gestational weight gain (time frame: At delivery). 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 21 Sep 2021.