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Recruiting NCT03085875

POWERMOM, A Healthy Pregnancy Research Community

Observational Pregnancy Related Weight Change, Body Health Problems in Pregnancy Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnancy Related, Weight Change, Body, Health Problems in Pregnancy, Behavior. Basic parameters: from 16 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Improve our understanding of healthy pregnancy weight gain for all women. [Time frame: Up to 46 weeks.]
  • Improve our understanding of how different factors impact pregnancy complications. [Time frame: Up to 46 weeks.]
  • Improve our understanding how different factors impact the birth of the baby. [Time frame: Up to 46 weeks.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Scripps Research Translational Institute — La Jolla

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. PMID 40194282

Identifiers

NCT: NCT03085875 · IRB-17-6924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗