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Pregnancy RelatedNCT05328622

Rewarding Healthy Behaviors in Pregnancy and Postpartum

A study testing Aqueduct Contingency Management Platform in people with Pregnancy Related, run by Transcendent International, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 52 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related
What is being tested?
Aqueduct Contingency Management Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
12 Jul 2022to 8 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 52 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai Hospital OB-Gyn Clinic E-Level

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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.
Read the 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.

Being tested
Aqueduct Contingency Management Platform
Keywords
Postpartum, Adherence, Prenatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aqueduct Contingency Management PlatformBehavioural

    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.

Study groups in NCT05328622
Study groupRoleWhat they receive
Adherence Incentives ProgramExperimentalThe 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.
Receives: Behavioral: Aqueduct Contingency Management Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 4 months

  3. 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.

    Measured: 4 months

Secondary outcomes (3)

  1. 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).

    Measured: 4 months

  2. 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).

    Measured: 4 months

  3. 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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start12 Jul 2022
  3. Primary completion8 May 2023
  4. Study completion8 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05328622
Sponsor's protocol ID
HHS-1R44NR020320-01A1
Status last verified
Dec 2023
First submitted
24 Mar 2022
Last updated
2 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aqueduct Contingency Management Platform in people with Pregnancy Related, run by Transcendent International, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of prenatal appointments attended (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05328622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.

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