Rewarding Healthy Behaviors in Pregnancy and Postpartum

Pregnancy Related Clinical Trial

Official title:

Rewarding Healthy Behaviors in Pregnancy and Postpartum With Aqueduct

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05328622
• Other study ID #: HHS-1R44NR020320-01A1
• Status: Completed
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: May 8, 2023

Study information

• Verified date: December 2023
• Source: Transcendent International, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 8, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital OB-Gyn Clinic E-Level	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Transcendent International, LLC	MOUNT SINAI HOSPITAL

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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