Clinical trial NCT05328622: Rewarding Healthy Behaviors in Pregnancy and Postpartum
Official title: Rewarding Healthy Behaviors in Pregnancy and Postpartum With Aqueduct
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Postpartum
Adherence
Prenatal
Lead sponsor: Transcendent International, LLC
Sponsor class: INDUSTRY
Collaborators: name: MOUNT SINAI HOSPITAL
First posted: 2022-04-14
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of prenatal appointments attended
timeFrame: 4 months
measure: Percentage of postpartum appointments attended
timeFrame: 4 months
measure: Percentage of eligible target population who consent to participate
timeFrame: 4 months
Secondary outcomes:
measure: Changes in healthy eating between baseline and follow-up
timeFrame: 4 months
measure: Changes in exercise habits between baseline and follow-up
timeFrame: 4 months
measure: Changes in self-efficacy between baseline and follow-up
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital OB-Gyn Clinic E-Level
state: New York
Study officials:
affiliation: Transcendent Endeavors
name: Aviva H Ariel-Donges, PhD, MPH
role: STUDY_DIRECTOR
References: