Harnessing the Power of Technology: MOMBA for Postpartum Smoking

NCT02237898 | Completed Phase 1 Results

• 2 other identifiers: 14070143265R01CA195654
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

Tobacco cessation

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Primary Outcome - Acceptability of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Acceptability of the smartphone application to low-income, pregnant women defined by the percentage of women who would recommend the site to a friend. Question: "How likely is it that you would recommend MoMba LiveLong to a friend who wants to stop smoking?"

  3 and 9 months

• Enrollment Rate

  Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: participation rate of \> 60% for eligible women between screening and enrollment. Number of women who were eligible from screening that completed an intake.

  15 months

• Remote Detection

  Primary outcome is the correlation coefficient. The correlation coefficient was calculated between the piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine cotinine levels. Data for all three instruments was collected during week 1 visits 1-5, 3 month, 9 month and 15 month assessments.

  15 months

• Retention: Number of Participants Remaining in Study at 12 Weeks

  Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: retention set at 80% for the Momba Smoking group. Number of participants in the intervention group (MoMba Contingency Management) and number of participants in the control group (office contingency management) who remained in the study at the end of contingency management (12 weeks).

  15 months

• Visit Attendance / Challenge Completion

  Primary Outcome - Feasibility of the delivery of financial incentives for smoking abstinence in postpartum women through a smartphone platform as compared to traditional, in office contingency management. Feasibility: challenge completion and in-office visit attendance to assess compliance. MoMba Contingency Management: Number of breath tests completed among participants who remained enrolled at the end of 12 weeks. Office Contingency Management: Number of breath tests (corresponds to office visits) completed among participants who remained enrolled at the end of 12 weeks.

  15 months

Secondary Outcomes (3)

• Number of Participants With Short Term Abstinence From Smoking

  3 months

• Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up

  9 months

• Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up

  15 months

Study Arms (2)

MoMba Contingency Management

EXPERIMENTAL

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.

Behavioral: MoMba Live Long app & Sensordrone™ carbon-monoxide sensor; Device: Sensordrone™ carbon-monoxide sensor; Device: MoMba Live Long Smartphone application

Office contingency management

ACTIVE COMPARATOR

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

Behavioral: Office contingency management; Device: Sensordrone™ carbon-monoxide sensor

Interventions

MoMba Live Long app & Sensordrone™ carbon-monoxide sensor BEHAVIORAL

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

MoMba Contingency Management

Office contingency management 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.

Office contingency management

Sensordrone™ carbon-monoxide sensor 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 Contingency Management; Office contingency management

MoMba Live Long Smartphone application 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.

MoMba Contingency Management

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 33231550 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Megan Smith
• Organization: Yale School of Medicine

megan.smith@yale.edu

(203) 764-8655

Study Officials

• Megan V Smith, DrPH

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 11, 2014
• Study Start: February 10, 2017
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)