Clinical trial NCT02237898: Harnessing the Power of Technology: MOMBA for Postpartum Smoking
Official title: SCH: INT: Harnessing the Power of Technology: MOMBA for Postpartum Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: Tobacco cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-11
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 3 and 9 months
measure: Enrollment Rate
timeFrame: 15 months
measure: Remote Detection
timeFrame: 15 months
measure: Retention: Number of Participants Remaining in Study at 12 Weeks
timeFrame: 15 months
measure: Visit Attendance / Challenge Completion
timeFrame: 15 months
Secondary outcomes:
measure: Number of Participants With Short Term Abstinence From Smoking
timeFrame: 3 months
measure: Number of Participants With Long Term Abstinence From Smoking at 9 Month Follow-Up
timeFrame: 9 months
measure: Number of Participants With Long Term Abstinence From Smoking at 15 Month Follow-Up
timeFrame: 15 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Center for Wellbeing of Women and Mothers, 40 Temple Street, Ste 6B, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Megan V Smith, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.