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POWERMOM, A Healthy Pregnancy Research Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03085875
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Scripps Translational Science Institute

Brief 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 health research to answer questions important to a broad population.

Condition or disease
Pregnancy Related Weight Change, Body Health Problems in Pregnancy Behavior

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.

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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: POWERMOM, A Healthy Pregnancy Research Community
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : March 13, 2027
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. Improve our understanding of how different factors impact pregnancy complications. [ Time Frame: Up to 46 weeks. ]
    Pregnancy complications will be collected using surveys.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women, 16 years or older, who currently live in the United States, and own a smartphone.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Inability to consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085875


Contacts
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Contact: Lase Ajayi, MD (858) 554-5734 tajayi@scripps.edu
Contact: Lauren M Ariniello, BS 858-784-2253 laurena@scripps.edu

Locations
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United States, California
Scripps Research Translational Institute Recruiting
La Jolla, California, United States, 92037
Contact: Gail Ebner    858-554-5717    gsebner@scripps.edu   
Contact: Lauren Ariniello       laurena@scripps.edu   
Principal Investigator: Steven R. Steinhubl         
Sponsors and Collaborators
Scripps Translational Science Institute
Investigators
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Principal Investigator: Lase Ajayi, MD The Scripps Research Institute
Additional Information:
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Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT03085875    
Other Study ID Numbers: IRB-17-6924
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scripps Translational Science Institute:
Weight Change
Healthy Pregnancy
Physiologic Sensors
Additional relevant MeSH terms:
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Body Weight Changes
Body Weight