Rewarding Healthy Behaviors in Pregnancy and Postpartum

NCT ID: NCT05328622

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-05-08

Brief Summary

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This is a single-arm pilot clinical trial with two primary research goals:

1. To test the efficacy of a software's ability to profile eligible individuals who decline participation in a clinical trial ("non-consenters") so that research staff may improve recruitment strategies for subsequent waves of potential participants.
2. To test the feasibility of using the software's contingency management program in a population of pregnant persons in their third trimester of pregnancy.

Detailed Description

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The first aim of the study is to test the feasibility of using a software program to incentivize pregnant patients to adhere to their prescribed prenatal appointments, postnatal appointment, and healthy behaviors. Participants will receive daily text messages that encourage engagement with health behaviors, and then participants earn points when they attend their scheduled appointments, bring in prescribed monitoring logs, and take their medications as prescribed.

A related aim of the study is to examine the effectiveness of the software system in providing support to researchers in implementing targeted participant recruitment in a manner that is labor-efficient and sustainable. The study will determine the efficacy of the software for (1) using psycho-demographic data to achieve more representative enrollment vis-à-vis target populations and (2) iteratively tailoring outreach materials and communication techniques based on actionable insights about those who participate and those who decline to participate.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive daily text messages and incentives for medical adherence. Recruitment will occur on a rolling basis, with participants completing the protocol in multiple waves.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Adherence Incentives Program

The intervention administered to participants is an incentive program designed to motivate participants to attend to/adhere to their prescribed prenatal course of care via the Aqueduct platform.

Group Type EXPERIMENTAL

Aqueduct Contingency Management Platform

Intervention Type BEHAVIORAL

All individuals who consent to participate will engage with the Aqueduct contingency management system. Once participants are enrolled, they accumulate points in Aqueduct for each prenatal/postpartum appointment they attend. They also earn points for attending pregnancy and birth related classes, monitoring their health (e.g., blood sugar, blood pressure), and taking prescribed medications. Participants then redeem their points for money on a Visa gift card.

Enrolled participants also receive daily text messages that contain motivational and mini-educational content regarding pregnancy from trusted sources such as the American College of Obstetricians and Gynecologists, Evidence Based Birth, and Postpartum Support International. These texts serve as reminders to participants to remain engaged in their pregnancy care.

Interventions

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Aqueduct Contingency Management Platform

All individuals who consent to participate will engage with the Aqueduct contingency management system. Once participants are enrolled, they accumulate points in Aqueduct for each prenatal/postpartum appointment they attend. They also earn points for attending pregnancy and birth related classes, monitoring their health (e.g., blood sugar, blood pressure), and taking prescribed medications. Participants then redeem their points for money on a Visa gift card.

Enrolled participants also receive daily text messages that contain motivational and mini-educational content regarding pregnancy from trusted sources such as the American College of Obstetricians and Gynecologists, Evidence Based Birth, and Postpartum Support International. These texts serve as reminders to participants to remain engaged in their pregnancy care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant in third trimester of pregnancy
* Between 18 and 52 years of age
* Able to read and speak either English or Spanish
* A patient at Mount Sinai Hospital's OB-Gyn Ambulatory E-Level Clinic

Exclusion Criteria

* Not pregnant (or no longer pregnant)
* Outside of age range
* Unwilling or unable to complete surveys
* Not a patient at the clinic of interest
Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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MOUNT SINAI HOSPITAL

OTHER

Sponsor Role collaborator

Transcendent International, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aviva H Ariel-Donges, PhD, MPH

Role: STUDY_DIRECTOR

Transcendent Endeavors

Locations

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Mount Sinai Hospital OB-Gyn Clinic E-Level

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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HHS-1R44NR020320-01A1

Identifier Type: -

Identifier Source: org_study_id

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