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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Protective Assets Reinforced With Integrated Care and Technology (PARITY): Protocol for a Randomized Controlled

Elizabeth Mollard1, Deirdre Cooper Owens2, Christina Bach1

  • 1College of Nursing, University of Nebraska Medical Center, Omaha, NE, United States.

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|August 8, 2024
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Summary
This summary is machine-generated.

This pilot study evaluates the PARITY program, combining a wellness technology platform and community doula support, to improve maternal health outcomes for Black women. Findings will inform a larger trial on reducing Black maternal health disparities.

Keywords:
African Americandoulahealth disparitiesmaternal healthmobile phone

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Area of Science:

  • Maternal Health
  • Health Disparities
  • Digital Health Interventions

Background:

  • Black women face disproportionately higher rates of severe maternal morbidity and mortality compared to White women.
  • The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program aims to address these disparities.
  • PARITY integrates a wellness technology platform with community doula support.

Purpose of the Study:

  • To determine the feasibility and acceptability of the PARITY intervention.
  • To investigate the preliminary efficacy of PARITY on clinical outcomes (blood pressure, weight gain, cesarean birth).
  • To assess changes in wellness behaviors and empowered strengths among participants.

Main Methods:

  • A pilot randomized controlled trial (RCT) with 60 Black pregnant individuals randomized 1:1 to intervention or control.
  • The intervention group receives a technology platform and doula support over 12 weeks.
  • Mixed methods evaluation including clinical and behavioral outcome measures from 20 weeks gestation to 12 weeks postpartum.

Main Results:

  • Recruitment, enrollment, and data collection are ongoing.
  • The study is funded by the National Institute of Nursing Research.
  • The estimated study completion date is October 2024.

Conclusions:

  • The study is expected to provide feasibility and preliminary efficacy data for the PARITY intervention.
  • Results will inform the design of a larger, 12-month PARITY program trial.
  • This research seeks to offer pragmatic solutions for Black maternal health disparities.