Rewarding Healthy Behaviors in Pregnancy and Postpartum

Rewarding Healthy Behaviors in Pregnancy and Postpartum With Aqueduct

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: Aqueduct Contingency Management Platform

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital OB-Gyn Clinic E-Level

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in healthy eating between baseline and follow-up	Using self-reported frequency of eating fruits, vegetables, and fried foods (measured as average number of days per week over the past month), the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased frequency in consumption of fruits and vegetables, as well as decreased fried food consumption, from baseline (start of third trimester) to follow-up (postpartum appointment ~6 weeks after giving birth).	4 months
Changes in exercise habits between baseline and follow-up	Using self-reported number of minutes of moderate intensity physical activity (measured as average minutes per week over the past month), the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased minutes of physical activity from baseline (start of third trimester) to follow-up (postpartum appointment ~6 weeks after giving birth).	4 months
Changes in self-efficacy between baseline and follow-up	Using the General Self-Efficacy questionnaire, the investigators will determine whether participants who received the Aqueduct system intervention demonstrate increased self-efficacy from baseline (start of third trimester) to follow-up (postpartum appointment ~6 weeks after giving birth). Respondents use a 5-point rating scale (1= strongly disagree; 3 = neither agree nor disagree; 5 = strongly agree). Total scores range from 8 - 40, with higher total scores indicating better/stronger self-efficacy. Instrument citation: Chen, G., Gully, S. M., & Eden, D. (2001). Validation of a new general self-efficacy scale. Organizational Research Methods, 4(1), 62-83. Accessed via https://sparqtools.org/mobility-measure/new-general-self-efficacy-scale/#all-survey-questions	4 months

Collaborators and Investigators

• Sponsor: Transcendent International, LLC
• Collaborators: MOUNT SINAI HOSPITAL
• Investigators: Study Director: Aviva H Ariel-Donges, PhD, MPH, Transcendent Endeavors

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 8, 2023

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Postpartum; Prenatal
• Other Study ID Numbers: HHS-1R44NR020320-01A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No