Study of a Smartphone-Based Alcohol Reduction Program

Trial feasibility is assessed with multiple measures of enrollment success; all are the percentage of potential participants that remain eligible after each pre-enrollment step.

1. The percent of potential participants who complete the online screening that are eligible for participation.
2. The percent of potential participants who complete the eligibility phone call that are eligible for participation.
3. The percent of potential participants who remain eligible after the screening call who consent and complete study enrollment (study enrollment includes: electronically signing the informed consent form, completing the baseline questionnaire, and completing registration in the app).

Trial feasibility is assessed with measuring the percent of enrolled participants who complete at least 80% of all study questionnaires.

Reported as the mean number of standard drinks per week over the past 7-28 days, based on the timeline follow-back (TLFB) calendar method.

Based on the average weekly alcohol consumption which is reported as the mean number of standard drinks per week over the past 7-28 days, based on the timeline follow-back (TLFB) calendar method.

Calculated as the number of participants with average drinks per day ≤ 2/day for men and ≤ 1/day for women over the specified time period, divided by the total number of enrolled participants.

The low-risk guideline for problematic drinking is defined as having consumed no more than 7 drinks per week and no more than 3 drinks on any single day (for women), or 14 drinks per week and no more than 4 drinks on any single day (for men).

Based on the average weekly alcohol consumption which is reported as the mean number of standard drinks per week over the past 7-28 days, based on the timeline follow-back (TLFB) calendar method.

Calculated as the number of participants meeting the above low-risk guideline criteria over the specified time period, divided by the total number of enrolled participants.

Reported as the mean number of standard drinks per day over the past 7-28 days, based on the timeline follow-back (TLFB) calendar method.

Reported as the mean number of standard drinks per drinking day (excluding days where no drinks were consumed) over the past 7-28 days, based on the timeline follow-back (TLFB) calendar method.

AUDIT-C = Alcohol Use Disorders Identification Test-Consumption (the first three questions from the 10-item AUDIT, a tool developed by the World Health Organization to evaluate a person's use of alcohol).

AUDIT-C scores range from 0 to 12 points, and are a sum of scores for each of its 3 questions. Lower scores indicate less alcohol use; higher scores indicate greater alcohol use. Unhealthy alcohol use in the U.S. is defined as a score greater than 4 for men, and a score greater than 3 for women.

The number of individuals that have AUDIT-C scores below these thresholds will be divided by the total number of participants to obtain this outcome proportion.

AUDIT-C = Alcohol Use Disorders Identification Test-Consumption.

AUDIT-C scores range from 0 to 12 points, and are a sum of scores for each of its 3 questions. Lower scores indicate less alcohol use; higher scores indicate greater alcohol use. Unhealthy alcohol use in the U.S. is defined as a score greater than 4 for men, and a score greater than 3 for women.

AUDIT-C scores can also be categorized into four risk levels: 0-4 indicates lower risk, 5-7 indicates increasing risk, 8-10 indicates higher risk, and 11 to 12 indicates possible dependence. An example of reducing by one risk level: a change from a score of 6, "increasing risk", at baseline to a score of 3, "lower risk", at follow-up.

The number of individuals that reduce their AUDIT-C score category by at least one risk level will be divided by the total number of participants to obtain this outcome proportion.

AUDIT = Alcohol Use Disorders Identification Test (10-items, a tool developed by the World Health Organization to evaluate a person's use of alcohol).

AUDIT scores range from 0 to 40 points. The score is a sum of scores for its 10 questions, each of which range from 0 to 4. Lower scores indicate less alcohol use; higher scores indicate greater alcohol use. Scores of 8 and greater are suggestive of an alcohol problem.

AUDIT scores can also be categorized into four risk levels: 0-7 indicates lower risk, 8-15 indicates increasing risk, 16-19 indicates higher risk, and 20+ indicates possible dependence. An example of reducing by one risk level: a change from a score of 9, "increasing risk", at baseline to a score of 5, "lower risk", at follow-up.

The number of individuals that have AUDIT scores of 7 or lower will be divided by the total number of participants to obtain this outcome proportion.

AUDIT = Alcohol Use Disorders Identification Test (10-items, a tool developed by the World Health Organization to evaluate a person's use of alcohol).

AUDIT scores range from 0 to 40 points. The score is a sum of scores for its 10 questions, each of which range from 0 to 4. Lower scores indicate less alcohol use; higher scores indicate greater alcohol use. Scores of 8 and greater are suggestive of an alcohol problem.

AUDIT scores can also be categorized into four risk levels: 0-7 indicates lower risk, 8-15 indicates increasing risk, 16-19 indicates higher risk, and 20+ indicates possible dependence. An example of reducing by one risk level: a change from a score of 9, "increasing risk", at baseline to a score of 5, "lower risk", at follow-up.

The number of individuals that reduce their AUDIT score category by at least one risk level will be divided by the total number of participants to obtain this outcome proportion.

Heavy drinking days are defined as days with ≥ 5 drinks for men and ≥ 4 drinks for women.

Based on the timeline follow-back (TLFB) calendar method; 7-day follow-back for weeks 1-12 and 28-day follow-back for weeks 26 and 52.

The number of heavy drinking days will be determined by counting the number of days of heavy drinking within each follow-back period.

Based on the timeline follow-back (TLFB) calendar method; 7-day follow-back for weeks 1-12 and 28-day follow-back for weeks 26 and 52.

The maximum number of drinks will be determined over the 7-day follow-back periods for weeks 1-12, and the 28-day follow-back periods for weeks 26 and 52.

Based on the timeline follow-back (TLFB) calendar method; 7-day follow-back for weeks 1-12 and 28-day follow-back for weeks 26 and 52.

Proportion of days abstinent will be calculated as number of days where 0 drinks were reported that day, out of the total number of days in that follow-back period (7 or 28).

Based on the timeline follow-back (TLFB) calendar method; 7-day follow-back for weeks 1-12 and 28-day follow-back for weeks 26 and 52.

Calculated as the average number of consecutive days where 0 drinks were reported on the timeline follow-back.

The WHO risk drinking levels are defined as follows:

low risk = 0 to 2.9 drinks/day (men) and 0 to 1.4 drinks/day (women) medium risk = 3.0 to 4.3 drinks/day (men) and 1.5 to 2.8 drinks/day (women) high risk = 4.4 to 7.1 drinks/day (men) and 2.9 to 4.3 drinks/day (women) very high risk = 7.2+ drinks/day (men) and 4.4+ drinks/day (women)

Based on the average daily alcohol consumption which is reported as the mean number of standard drinks per day over the past 7-28 days, based on the timeline follow-back (TLFB) calendar method. Example of reducing one drinking level: a woman decreasing from an average of 3 drinks per day (high risk) to an average of 2 drinks per day (medium risk).

The number of individuals that reduce their WHO risk drinking level by at least one level will be divided by the total number of participants to obtain this outcome proportion.

Adverse consequence related to alcohol are assessed via the short inventory of problems revised (SIP-R), a15-item measure. The 15 items are rated on a 4-point scale (from 0-3); 0 = Never, 1 = Once or a few times, 2 = Once or twice a week, 3 = Daily or almost daily.

Scores for the SIP-R range from 0 to 45, where a higher score indicates experience with greater adverse consequences related to alcohol.

Drinking motivations are assessed via the Drinking Motivation Questionnaire Revised (DMQR, 20 items). The 20 items are rated on a 5-point Likert scale (from 1-5); 1 = Almost Never/Never, 2 = Some of the time, 3 = Half of the time, 4 = Most of the time, 5 = Almost Always/Always.

This scale has 5 items each for reflecting the following four categories of motives: social, coping, enhancement, and external social pressures.

The DMQR yields four scale scores (between 5 and 25) reflecting each of these motives for drinking alcohol, where a higher score indicates greater frequency of the reason motivating them to drink alcohol.

Participants are asked: "Do you have any desire to change your drinking habits?"

With the following options to answer:

• No, I'm comfortable with my current habits
• No, I know I could drink a little less but I'm not motivated to change right now
• Yes, I'm interested in drinking a little less
• Yes, I'm interested in drinking a lot less
• Yes, I'm interested in stopping drinking for a short period of time
• Yes, I'm interested in stopping drinking for a long period of time

Participants are asked: "What are your reasons for wanting to change your drinking?" The following options are provided (participants select all that apply): physical health/disease prevention or disease management, physical wellness/fitness, spend less money, diet/reduce calorie intake, mental health, mindfulness goals, relationship improvement, work/career improvement, or other (please describe).

Participants are then asked to rank the selected options starting at 1 = Most important (ending at the number of reasons that were selected).

Participants are asked: "How ready are you to make changes to your drinking habits?" Answered on a range from 1-10; 1 = not at all ready, 10 = extremely ready. A higher score indicates greater readiness to change drinking habits.

Participants are asked: "If you were to change your drinking habits now, how successful would you be?" Answered on a range from 1-10; 1 = not at all successful, 10 = extremely successful. A higher score indicates greater expected success in changing drinking habits.

Participants are asked: "If you were to change your drinking habits now, how difficult do you think it would be to keep your new habits?" Answered on a range from 1-10; 1 = not difficult at all, 10 = extremely difficult. A higher score indicates greater expected difficulty to change drinking habits.

Participants are asked: "How satisfied are you with your current drinking behavior?" Answered on a range from 1-10; 1 = not at all satisfied, 10 = very satisfied. A higher score indicates greater satisfaction with current drinking behavior.

Assessed with the following question: "How easy or difficult was it to set-up and get started in the Pivot program?" Participants answer on a 1-10 scale; 1 = very difficult, 10 = very easy. A higher score indicates an easier time setting up and getting started with the program.

Specifically regarding likelihood to recommend to a friend or colleague, Net Promoter Score (NPS). Participants are asked: "How likely would you be to recommend the Pivot Clear program to a friend or colleague that had a desire to drink less?" Answered on a range from 1-10; 1 = not at all likely, 10 = very likely. A higher score indicates greater user satisfaction and promotion of the program.

Participants are asked: "How has using the Pivot program affected your alcohol consumption?"

Participants are provided with the following options to choose from:

• Using the program has increased my alcohol consumption
• Using the program has not affected my alcohol consumption
• Using the program has decreased my alcohol consumption

Participants are asked: "Did you find the Pivot Clear program effective so far?".

Participants are provided 4 choices to answer: very effective, somewhat effective, not really effective, not at all effective

Participants are presented with the following statement: "The program has helped me maintain a new drinking level where I drink less than when I started the study." Participants are asked to select True/False.

Participants are asked: "Which of the following best describes the Pivot Clear program's ability to help someone reduce or quit alcohol?"

Participants are provided the following options to choose from:

• The program is extremely helpful
• The program is helpful
• The program does not affect being able to reduce or quit alcohol
• The program makes reducing or quitting alcohol more difficult

Participants are asked: "Which of the following best describes your need for the Pivot Clear program".

Participants are provided the following options to choose from:

• I really need this program
• I somewhat need this program
• I don't need this program
• I am not at all interested in this program

Participants are asked: "How has using the Pivot program affected your motivation to change your drinking habits?"

Participants are provided with the following options to choose from:

• Using the program has increased my motivation to change my drinking habits
• Using the program has not affected my motivation to change my drinking habits
• Using the program has decreased my motivation to change my drinking habits

Participants are asked: "What best describes your initial reaction to finding out a [breathalyzer; coach; drink tracker] was a part of this program?"

Participants are provided the following to choose from:

• I thought it was out of place in the program as I think it is [a legal/compliance/negative tool for; a substance abuse counselor for; only used by] those with a severe drinking problem
• I don't think it is necessary or helpful
• I was curious about it and didn't have strong feelings
• Made sense to me as this was a program related to [alcohol, behavior change, alcohol consumption behavior]
• I was very interested to use it

Participants are asked various questions regarding program features and design.

Participants are asked: "Have you gained any insights from your [initial use of the breathalyzer; initial interactions with the drink tracker in the Pivot app; initial interactions with the coach; interactions with the lessons]? Check all that apply."

Participants are provided the following options to choose:

• Not applicable
• Not really
• It confirmed what I already thought
• It was motivating
• It was demotivating
• It triggered me to drink more
• It triggered me to drink less

Participants are asked: "What aspect of the program do you enjoy the most so far?" and "What aspect of the program do you enjoy the least so far?".

For both questions they are provided the following to choose from:

• Coaching
• Tracker
• Lessons
• Breathalyzer
• Other app contents/features (please specify)

Participants are asked about potential future program features (small interest groups, breathalyzer connected to the app, text-based community, coaching via phone calls).

They are provided the following to choose from:

• Very interested
• Somewhat interested
• Probably not interested
• Definitely not interested
• Comments (optional)

Assessed via self-report. Participants are asked about other alcohol reduction or abstinence tools they have used throughout the last 6 months. Tools asked about include: apps (other than Pivot), counseling, medications, acupuncture, hypnotherapy, etc. Participants can report other tools not included in the list provided. Outcome reported as the number of participants who have used each other alcohol reduction or abstinence tools.

Collected via back-end app data collection. Engagement is specifically assessed with number of times the Pivot app was opened (number of app openings), number of days the app was opened, and the number of weeks the app was opened. All are assessed over the first 26 weeks of study enrollment.

Collected via back-end app data collection. Engagement is specifically assessed with the number of days over which the app was opened by participants over the first 26 weeks of study enrollment.

Collected via back-end app data collection. Engagement is specifically assessed with the number of weeks over which the app was opened by participants over the first 26 weeks of study enrollment.

Collected via back-end app data collection. Engagement is specifically assessed with the average duration of app sessions completed by participants over the first 26 weeks of study enrollment. Outcome unit of measure = duration in minutes.

Collected via back-end app data collection. Engagement is specifically assessed with the use of app features (Lessons, Drink Logging, Crush a Craving, Challenges/Triggers, Goal Setting) by participants over the first 26 weeks of study enrollment. Reported as the number of times each app feature was used.

Collected via back-end app data collection. Engagement is specifically assessed with average number of messages sent by coach to participant per week and average number of messages sent by participant to coach per week, over the first 26 weeks of study enrollment.

Collected via back-end app data collection. Specifically, the average number of weeks with at least one message sent from participant to coach over the first 26 weeks of study enrollment.

The following health indicators are assessed: sleep quality, nutrition/diet quality, weight management, ability to manage stress, physical fitness, mental health (anxiety, depression, bipolar as applicable), and chronic diseases (cardiovascular disease, diabetes, high blood pressure, asthma, COPD, acid reflux as applicable).

COPD = chronic obstructive pulmonary disease

Participants are asked to rate each of the above health indicators on a scale of 1-5; 1 = poor, 5 = excellent.

Ratings at each timepoint are compared to the baseline score to determine their change.

The following health indicators are assessed: sleep quality, nutrition/diet quality, weight management, ability to manage stress, physical fitness, mental health (anxiety, depression, bipolar as applicable), and chronic diseases (cardiovascular disease, diabetes, high blood pressure, asthma, COPD, acid reflux as applicable).

Participants are asked to rate each based on if they experienced any positive change in that area due to reduced drinking; scale 1-5; 1 = not at all, 5 = very much. Greater scores on the scale indicate greater positive change experienced in that area of health.

The ratings for each health indicator are averaged across participants to generate the average rating.

Assessed via the Center of Epidemiological Studies Depression Scale (CES-D) screening questionnaire, 10 items. A score is calculated from a sum of the 10 items. Possible scores on the scale range from 0-30. Higher scores indicate greater severity of depressive symptoms, a worse outcome.

Anxiety is assessed via Generalized Anxiety Disorder 7-item scale (GAD-7). The following is asked regarding the 7 items: "Over the last two weeks, how often have you been bothered by the following problems?". The 7 items are rated on a 4-point scale (from 0-3); 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day.

Scores for the GAD-7 range from 0 to 21, where a higher score indicates greater severity of anxiety, a worse outcome. The following are score ranges and their associated anxiety severity: 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.

Resilience is assessed via The Brief Resilience Scale (6-item, self-report measure).

The 6 items are rated on a 5-point scale (from 1-5); 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree.

Scores for the Brief Resilience Scale range are a result of adding the scores for the 6 items together and dividing that total by 6 (this is the average score for the items). Scores range from 1 to 5, where a higher score indicates greater resilience, a better outcome.

Well-being is assessed via the WHO-5 Well-being Index (5 items) score.

The 5 items are rated on a 6-point scale (from 5-0); 5 = All of the time, 4 = Most of the time, 3 = More than half the time, 2 = Less than half the time, 1 = Some of the time, 0 = At no time.

Scores for the WHO-5 Well-being Index result from adding the scores for the 5 items together. The score ranges from 0 to 25, where a higher score indicates greater well-being and quality of life, a better outcome.