Pregnancy RelatedNCT03085875
POWERMOM, A Healthy Pregnancy Research Community
An observational study of Pregnancy Related and Weight Change, Body, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Weight Change, Body, Health Problems in Pregnancy
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2017to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women, 16 years or older, who currently live in the United States, and own a smartphone.
Who may be able to join
- Adults, 16 years of age or older
- Pregnant women or within 8 weeks postpartum
- Currently live within the United States
- Own, and comfortable using, a smartphone or tablet
Who cannot join
- Inability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Scripps Research Translational Institute
La Jolla, California, 92037
Gail Ebner, 858-554-5717, gsebner@scripps.edu
Lauren Ariniello, laurena@scripps.edu
About this study
This study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world health research to answer questions important to a broad population.
Read the detailed description
- Eligibility determined, Individuals enrolled and consented to join study
- Short Intake Survey (demographic and baseline health information collected)
- Health History Survey (two days after participant enrolls in the study)
- Survey questions about current health and medical history will be sent to participants weekly. If participants had a prenatal visit during the week, a few additional questions will be asked.
- Twins / Multiples survey will begin appearing when a participant indicates they are having more than one baby
- Participants can submit home measurements of, weight and blood pressure as frequently as they want through HealthKit.
- Pregnancy outcome variables. (Miscarriage, stillbirth, birth of healthy baby, or pregnancy ended) will also be asked weekly.
- If the baby is born, questions about labor and delivery, as well as weight, size and birth date of the baby will be asked. A reminder to fill out the outcome survey will be given 4 weeks after a user's due date.
- Keywords
- Weight Change, Healthy Pregnancy, Physiologic Sensors
- Medical subject headings
- Body Weight Changes, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve our understanding of healthy pregnancy weight gain for all women.
Weight (lbs.) will be collected using surveys and measured with home and medical office scales.
Measured: Up to 46 weeks.
Improve our understanding of how different factors impact pregnancy complications.
Pregnancy complications will be collected using surveys.
Measured: Up to 46 weeks.
Improve our understanding how different factors impact the birth of the baby.
Birth outcomes will be collected using surveys.
Measured: Up to 46 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start16 Mar 2017
- Primary completion13 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lase Ajayi, MD, Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085875
- Sponsor's protocol ID
- IRB-17-6924
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2017
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ajayi T, Kueper J, Ariniello L, Ho D, Delgado F, Beal M, Waalen J, Baca Motes K, Ramos E. Digital Health Platform for Maternal Health: Design, Recruitment Strategies, and Lessons Learned From the PowerMom Observational Cohort Study. JMIR Form Res. 2025 Apr 7;9:e70149. doi: 10.2196/70149.
PubMed 40194282
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POWERMOM, A Healthy Pregnancy Research Community
- ClinicalTrials.gov ID
- NCT03085875
- Acronym / sponsor ID
- IRB-17-6924
- Keywords
- Weight Change, Healthy Pregnancy, Physiologic Sensors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 13 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 21 Mar 2017 (actual)
- 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 study will take advantage of the open source framework of ResearchKit developed by Apple to bring research directly to participants. Using the ResearchKit platform as well as a stand alone app available for Android and HTML, it makes it easier to enroll large numbers of participants and carry out real-world health research to answer questions important to a broad population.
Detailed description
- Eligibility determined, Individuals enrolled and consented to join study
- Short Intake Survey (demographic and baseline health information collected)
- Health History Survey (two days after participant enrolls in the study)
- Survey questions about current health and medical history will be sent to participants weekly. If participants had a prenatal visit during the week, a few additional questions will be asked.
- Twins / Multiples survey will begin appearing when a participant indicates they are having more than one baby
- Participants can submit home measurements of, weight and blood pressure as frequently as they want through HealthKit.
- Pregnancy outcome variables. (Miscarriage, stillbirth, birth of healthy baby, or pregnancy ended) will also be asked weekly.
- If the baby is born, questions about labor and delivery, as well as weight, size and birth date of the baby will be asked. A reminder to fill out the outcome survey will be given 4 weeks after a user's due date.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women, 16 years or older, who currently live in the United States, and own a smartphone.
Key inclusion criteria (4 listed)
- Adults, 16 years of age or older
- Pregnant women or within 8 weeks postpartum
- Currently live within the United States
- Own, and comfortable using, a smartphone or tablet
Key exclusion criteria (1 listed)
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improve our understanding of healthy pregnancy weight gain for all women.
Time frame: Up to 46 weeks.
Weight (lbs.) will be collected using surveys and measured with home and medical office scales.
Improve our understanding of how different factors impact pregnancy complications.
Time frame: Up to 46 weeks.
Pregnancy complications will be collected using surveys.
Improve our understanding how different factors impact the birth of the baby.
Time frame: Up to 46 weeks.
Birth outcomes will be collected using surveys.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 40194282Ajayi T, Kueper J, Ariniello L, Ho D, Delgado F, Beal M, Waalen J, Baca Motes K, Ramos E. Digital Health Platform for Maternal Health: Design, Recruitment Strategies, and Lessons Learned From the PowerMom Observational Cohort Study. JMIR Form Res. 2025 Apr 7;9:e70149. doi: 10.2196/70149.
- This study is being conducted online through the MyDataHelps app, study code PWRMOMLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lase Ajayi, MD principal investigator
The Scripps Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Weight Change, Body, run by Scripps Translational Science Institute 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 1 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: looking for participants now, as of the sponsor's last update on 17 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lase Ajayi, MD ((858) 554-5734, tajayi@scripps.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve our understanding of healthy pregnancy weight gain for all women. (time frame: Up to 46 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03085875, which also lists 1 linked publication.
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 17 Apr 2024.