Rewarding Healthy Behaviors in Pregnancy and Postpartum

NCT05328622 | Completed

• 1 other identifier: HHS-1R44NR020320-01A1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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.

Conditions

Pregnancy Related

Keywords

Postpartum; Adherence; Prenatal

Outcome Measures

Primary Outcomes (3)

• Percentage of prenatal appointments attended

  Using data from Mt. Sinai's electronic medical record appointment tracking system, the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased attendance at scheduled prenatal visits compared with baseline data in the clinic about attendance rates.

  4 months

• Percentage of postpartum appointments attended

  Using data from Mt. Sinai's electronic medical record appointment tracking system, the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased attendance at scheduled postpartum visits compared with baseline data in the clinic about attendance rates.

  4 months

• Percentage of eligible target population who consent to participate

  Using descriptive statistics from recruitment, the investigators will determine whether the percentage (%) of eligible individuals from the population of pregnant women in their third trimester receiving prenatal care at the Mt. Sinai E-Level OB Clinic who elected to participate in the study increases between Wave 1 and Wave 2 of recruitment based upon changes in recruitment language.

  4 months

Secondary Outcomes (3)

• Changes in healthy eating between baseline and follow-up

  4 months

• Changes in exercise habits between baseline and follow-up

  4 months

• Changes in self-efficacy between baseline and follow-up

  4 months

Study Arms (1)

Adherence Incentives Program

EXPERIMENTAL

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.

Behavioral: Aqueduct Contingency Management Platform

Interventions

Aqueduct Contingency Management Platform 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.

Adherence Incentives Program

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Transcendent International, LLC: lead
• MOUNT SINAI HOSPITAL: collaborator

Study Sites (1)

Mount Sinai Hospital OB-Gyn Clinic E-Level

New York, New York, 10029, United States

Location

Study Officials

• Aviva H Ariel-Donges, PhD, MPH

  Transcendent Endeavors

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 14, 2022
• Study Start: July 12, 2022
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)