Rewarding Healthy Behaviors in Pregnancy and Postpartum

Transcendent International

Status: Completed

Conditions: Pregnancy Related

Treatments: Behavioral: Aqueduct Contingency Management Platform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05328622

HHS-1R44NR020320-01A1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Adherence Incentives Program

Experimental group

Description:

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.

Treatment:

Behavioral: Aqueduct Contingency Management Platform