SCH: INT: Harnessing the Power of Technology: MOMBA for Postpartum Smoking
Phase: PHASE1
Conditions: Smoking Cessation
Sponsor: Yale University

Harnessing the Power of Technology: MOMBA for Postpartum Smoking 
 
NCT02237898 
 
09/07/2017

Overview: Through a pilot, randomized control trial tested the effectiveness of Momba Live 
Long (the Momba Live Long application and sensor) on 7-day point prevalence of smoking 
abstinence rates i) at the end of the trial and ii) at 3-month follow-up as determined by the 
Timeline Follow Back instrument and number of negative breath tests. 
The randomized controlled trial of Momba Live Long utilized a control group which received 
financial incentives at an in-person office/clinic visit based on expired CO levels obtained 
through the piCO+™ CO sensor compared to the MoMba Livelong application. We used results 
from frequently administered assessment instruments over the course of an 3-month period and  
subsequent 6- and 12-month follow ups to assess outcomes and to examine the reliability and 
validity of assessment measures, and key methodological parameters, such as effect size, 
proportion of eligible and willing study participants, attrition rate, time necessary for data 
collection, and necessary skill sets for CMHAs. The RCT involved an intervention arm (10 
women who receive Momba Live Long) and “control” arm (10 women who receive financial 
incentives delivered in-person in the office). Participants were randomized using a number 
generation mechanism provided to the CMHAs who are screening and enrolling women. 
 
Intervention Group (Momba Live Long): The intervention group received a smartphone, data 
plan, Momba Live Long, including the Bluetooth enabled CO sensor, and training from a CMHA 
on its use. The intervention group did most of its CO tests remotely, outside of a baseline, 3-
month end point assessment, and 6-month and 12-month follow-ups.  However, participants also 
came n for the first 5 days of week 1 to be trained on how to use the Sensordrone and Momba 
Live Long app.  As part of this training, we showed the intervention group participants a 
Demonstration Video and a Powerpoint Presentation about how to use the Momba Live Long 
Application.  Intervention group participants came to the office for a visit in Week 4 and Week 8 
to calibrate the Sensordrone and to submit a urine specimen.  
 
Control Group: Control group mothers received traditional, in-office contingency management 
to prevent smoking relapse. Financial incentives were delivered according to the same schedule 
at the same frequency as those delivered to mothers on Momba Live Long. The exception was 
that mothers in Momba Live Long will also receive payment for completing tasks that promote 
abstinence. Overall, the amount of Contingency Management incentives in the two groups were 
similar. Thus, we were not directly comparing the effectiveness of contingency management that 
has already been well established, but rather we assess the effectiveness of contingency 
management delivered over a smartphone application vs. traditional contingency 
management in an office setting. Women in each condition were provided with the Staying 
Smoke Free curriculum.  Mothers in the control condition completed the same assessment 
battery and according to the same schedule as participants in the Momba Live Long application 
group and were compensated similarly.  During the first 3 months, control group participants 
completed assessments with staff during office visits. In months 4-12, surveys were administered 
via Qualtrics links on personal smartphones, over the phone with research staff, or by mailing the 
surveys to and from participants’ homes.  Control group CM breath tests were conducted with 
the piCO+™, considered as “traditional” Contingency Management. They also completed 
Sensordrone CO tests for comparison purposes with the Intervention Group.    Control 
participants were also be compensated for attending each scheduled CO test office visit. 
 

Participants: Women who were smoking in the second or third trimester of pregnancy, with no 
complicating general medical or psychiatric conditions (including other substance use disorder) 
were eligible. Women were not receiving other smoking cessation medication. Mothers were not 
eligible to participate if they were planning to move out of the New Haven area in the next 15 
months after study enrollment, had medical complications that would interfere with testing the 
Sensordrone, or were actively suicidal, psychotic or unable to provide informed consent. 
 
Screening and Enrollment: We used rolling enrollment (over a 
2-month period) and women were followed up to 15 months after study start date. Following a 
brief description of the study by the Community Mental Health Ambassadors (CMHAs), 
mothers who live in New Haven and have been trained as research assistants, at a woman’s 
prenatal visit at YNHH or at a community hub visit, women were screened in person or over the 
phone for smoking status using the Fagerstrom Test for Nicotine Dependence (FTND), a six-
item self-report form that gives a quantitative measure of the severity of nicotine 
dependence.(37) The study screening form collected personal contact information and significant 
other contact information as well as demographics and health history. An abbreviated version of 
the Mental Test Score (33) was used to determine any cognitive impairment or inability to 
provide informed consent.  The CMHAs performed a brief in-person or phone screening, a more 
complete in-office screening for those still eligible (including submitting a urine specimen to 
confirm pregnancy and cotinine and to exclude other drug use), and obtained written informed 
consent.  
 
The screening consent also included a Release of Information (ROI) from YNHH and other local 
medical providers to obtain medical records about pregnancy and smoking status, pregnancy 
complications and medical exclusion criteria.  These records were reviewed to confirm medical 
conditions which may interfere with the results of the Sensordrone.  A second Release of 
Information was completed with the consent to participate requesting information about 
pregnancy and delivery status. 
  
All women were approached until the target enrollment has been reached.  
 
Delivery of the Momba Live Long Intervention: After completion of screening, consents and 
intake interview, women were provided with a smartphone and data plan, a carbon monoxide 
sensor compatible with their phone, access to the Momba Live Long application, and training on 
its use by the CMHAs. This exchange of equipment and training occured at our office at the end 
of week 1 of study start date.  Testing of CM lasted 12 weeks. 
 
In office monitoring: Women were required to come into the office to perform in-person CO 
breath tests using the Sensorcon Sensordrone™ and Bedfont piCO+™ in order for us to continue 
to compare data on the reliability and validity of the Sensordrone. At each office visit women 
completed additional questionnaires and urine tests to measure cotinine levels to provide 
additional data on the validity of the Sensordrone™ and other drug use (to see if these other 
drugs affect how well the Sensordrone performs).   
 
Financial incentives were delivered based on the CO breath test. We followed standard protocols 
for in office monitoring of smoking abstinence and the delivery of financial incentives in 

pregnant and postpartum women. These included the provision to all participants of the Smoke 
Free curriculum in addition to the financial incentives to promote abstinence. We required 
women to report to our clinical office for 5 consecutive days for abstinence monitoring the first 
week of study enrollment. The frequency of in-office abstinence monitoring decreased to twice 
weekly in week 2.  Frequency of visits in weeks 3-12 depended on accuracy of the Sensordrone; 
at most, in weeks 3-8 it was twice per week and in weeks 9-12 it was once per week.   In-office 
visits for breath tests were not required after week 12.  
 
 
Administration of Standardized Measures: All follow-up measures, with the exception of 
baseline, post, and 6-month post CM and 12-month post CM follow-ups (administered in-office 
by research assistants, and mostly on a laptop computer) were administered via the Momba Live 
Long application. Mothers were prompted by the Momba Live Long application upon login and 
push notifications, to complete the questionnaires at specified intervals. The outcome measures 
we assessed were: (1) acceptability of the smartphone application to low-income, pregnant 
women (as defined by the percentage of women who would recommend the site to a friend); (2) 
point and 7-day smoking prevalence as determined by the Timeline Follow Back assessment, and 
# of negative breath tests, (secondary outcome); and (3) correlation coefficients between the 
piCO+™ and the Sensordrone™ specific to expired CO measurement and verified through urine 
cotinine levels. 
 
The Phen-X was used to generate diagnoses of depression, anxiety disorders (including trauma 
and stress disorders), and substance use disorders at baseline and 6-month follow-up. We will 
collect detailed information about enrolled mothers from the eligibility screening interview and 
baseline and outcome assessments. Specific instruments utilized and delivered via the Momba 
Live Long application and the in-person office visits included:  
Smoking cessation outcome assessments- In addition to the results of the CO monitor (which 
only can detect nicotine levels up to 2 to 3 hours after a cigarette), urine will be tested in the 
office with a qualitative cotinine cassette test from Redwood Toxicology Laboratory and sent to 
the Dept. Laboratory Medicine, at Yale School of Medicine for confirmation and cotinine levels.  
Other drugs tested in the office using cassette and dip tests from Redwood Toxicology 
Laboratory will be for amphetamines, barbiturates, benzodiazepines, cocaine, methadone, 
Methamphetamine, opiates, PCP, THC and Oxycodone.Self-report of cigarette smoking history 
was collected with the timeline follow-back (TLFB) for the past 28 days. Measures at post,  6M 
post CM and 12M post CM included the Fagerstrom Test for Nicotine Dependence,  and the self-
report of cigarette smoking history using the timeline follow-back (TLFB) for the past 28 days. 
 
 
Proposed Analytic Plan:  The goal of the proposed analysis is to determine the feasibility of 
the web-based intervention and acceptability and perceived value of the Momba Live Long 
smartphone-based system. We will evaluate progress toward these goals looking specifically at: 
(1) ensuring a process exists to assess best practices and participant opinion and integrate them 
into Momba Live Long and (2) ensuring procedures exist to support and monitor intervention 
delivery and dissemination. 
 

We will develop Momba Live Long, test it, observe the results, and provide feedback, tracking 
relevant process measures and repeatedly assessing: 
  time burden, sensor functionality (including the establishment of validity of the reading with 
the traditional expired CO monitor), integration into daily lifestyle, requirements for 
additional training for women on the hardware (phone and sensor) and smartphone 
application, women’s reactions to Momba Live Long’s immediate incentive system, and 
unexpected or potentially adverse events (including loss/sale of equipment); 
  number of women approached, consented, and # of logins to the application, time of 
logon, modules visited, time per module, time per sensor challenge, # of training sessions 
delivered by the CMHAs, # of contacts made by women to the CMHAs; 
 
To quantitatively evaluate the feasibility and acceptability of Momba Live Long to 
postpartum women we will begin by calculating the number of women screened and eligible 
and enrolled.  We will collect data on reasons women are not enrolled.  We will consider a 
participation rate of > 60% for eligible women between screening and enrollment as 
supportive of feasibility. We will evaluate retention and set a threshold of 80% for the 
Momba Live Long group. Since feasibility also depends upon compliance to the challenges 
or office visits through which contingency management is delivered, we will use challenge 
completion and in-office visit attendance to assess compliance. Mixed-effects regression 
models will be conducted as outlined above for group comparisons. Because number of 
visits attended is a count variable, random effects regression with a negative binomial model 
will be used which is appropriate for count data.(45)  Additional procedures to evaluate 
abstinence from smoking are described below.  
 
 
Data Analysis for Pilot RCT: Descriptive statistics will summarize the data on all screened and 
randomized subjects. Baseline demographic and clinical characteristics for the randomized 
groups will be compared using chi-square tests for categorical variables and analysis of variance 
for continuous variables. All continuous variables will be examined for adherence to the normal 
distribution using normal probability plots and Kolmogorov-Smirnov tests. Dropouts and 
completers will also be compared on baseline characteristics using the same approach. Data 
analyses will be conducted using the intent-to-treat principle. We will use mixed-effects 
regression models  to compare the two groups (Momba Live Long vs. in-office contingency 
management) using SAS PROC MIXED version 9.3. These models allow for different numbers 
of observations per subject, use all available data on each subject, and are unaffected by 
randomly missing data. They are flexible in modeling the correlation structure of the data. In 
each model, we will include fixed effects of time, group (Momba vs. in-office) and time by 
group, and random subject effects. If there are concerns of informative dropout and/or 
informative intermittent missing data, we will use pattern mixture models to perform sensitivity 
analyses to our main analyses.  
For the RCT dependent variables are the 7-day point prevalence of smoking abstinence 
rates i) at the end of the trial and ii) at 3-month follow-up. We will also compare 2-week 
continuous smoking abstinence rates at these time points. Smokers are considered abstinent 
based on self-reported smoking abstinence verified by CO levels <6 ppm and self-report 
abstinence based on the Timeline Follow Back. (50) Because abstinence is categorical, a binary 
random effects logit model will be used. (51) As a secondary analysis, we will add an indicator 
variable for intensity of utilization for Momba Live Long application to the model in order to 
determine if it contributes significantly to response. Given that this is a pilot, we are not powered 

to detect a significant difference on our outcomes. However, we will develop effect sizes to 
estimate power for a larger study and we will evaluate the direction and consistency of effects.  
We use guidelines for Stage 1b studies, which suggest 15-30 participants per cell. (52) For the 
outcome of 7-day point prevalence for smoking abstinence at the end of the trial, and 15 subjects 
per condition, a 2-tailed alpha of .05 we will have power of 90% if we have the same effect size 
found in other studies of contingency management with perinatal women smokers. (34)  In all 
likelihood, the effect will be smaller for the 3-month outcomes.  However, these results will 
provide a reasonable estimate with which to power a larger study.