Harnessing the Power of Technology: MOMBA for Postpartum Smoking

NCT ID: NCT02237898

Last Updated: 2020-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2019-05-13

Brief Summary

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Through a smartphone platform, financial incentives for smoking abstinence in postpartum women can be delivered remotely, thus minimizing the need for participants to come to the office to receive traditional contingency management.

Detailed Description

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The specific aims of the proposal are:

1. To develop through a 15-month pilot study, a novel smartphone-based system, Momba Smoking, that can be used in further relapse prevention trials for postpartum smokers.
2. To determine, through a pilot randomized controlled trial, the potential feasibility, acceptability, and methodological parameters that are necessary to design a subsequent, appropriately powered, randomized controlled trial of the Momba Smoking smartphone-based system.
3. To advance discovery and understanding on the use of technology to translate smoking cessation interventions from clinical to community settings through the training of the next generation of scientists.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MoMba Contingency Management

Study will provide access to the web-based MoMba Live Long application \& Sensodrone™ carbon-monoxide sensor for purposes of researching the acceptability of the smartphone application, operating and functioning of it, and providing remote contingency management for smoking cessation to postpartum women.

Group Type EXPERIMENTAL

MoMba Live Long app & Sensordrone™ carbon-monoxide sensor

Intervention Type BEHAVIORAL

MoMba Live Long application \& Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely

Sensordrone™ carbon-monoxide sensor

Intervention Type DEVICE

A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.

MoMba Live Long Smartphone application

Intervention Type DEVICE

The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.

Office contingency management

Traditional contingency management with financial incentives delivered in-person in the office for smoking cessation to postpartum women

Group Type ACTIVE_COMPARATOR

Office contingency management

Intervention Type BEHAVIORAL

A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.

Sensordrone™ carbon-monoxide sensor

Intervention Type DEVICE

A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.

Interventions

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MoMba Live Long app & Sensordrone™ carbon-monoxide sensor

MoMba Live Long application \& Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely

Intervention Type BEHAVIORAL

Office contingency management

A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.

Intervention Type BEHAVIORAL

Sensordrone™ carbon-monoxide sensor

A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.

Intervention Type DEVICE

MoMba Live Long Smartphone application

The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women who are over the age of 18
* Speak English
* Second or third trimester of pregnancy
* Smoking in the third trimester of pregnancy
* No complicating general medical or psychiatric conditions (including marijuana use).

Exclusion Criteria

* Receiving other smoking cessation medication
* Planning to move out of New Haven in the next 15 months
* Actively suicidal, psychotic or unable to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan V Smith, DrPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Valencia S, Callinan L, Shic F, Smith M. Evaluation of the MoMba Live Long Remote Smoking Detection System During and After Pregnancy: Development and Usability Study. JMIR Mhealth Uhealth. 2020 Nov 24;8(11):e18809. doi: 10.2196/18809.

Reference Type DERIVED
PMID: 33231550 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R01CA195654

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1407014326

Identifier Type: -

Identifier Source: org_study_id

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