Protocol

The GeoSmoking Study investigates the causal effects of exposure to tobacco retail environments on smoking behavior and neural reactivity among daily cigarette smokers.

Study Setting and Design

🏛️ Study Overview

The GeoSmoking Study was conducted at the University of Pennsylvania. Adults who smoked cigarettes daily were recruited across PA, DE, and NJ to complete a multi-part remote study.

The study consisted of three main components:

Phase 1

Baseline Period

2 weeks - EMA reporting, geolocation tracking, tobacco retail exposure assessment

Phase 2

Intervention Period

4 weeks - Randomized store visits, continued EMA and geolocation tracking

Phase 3

fMRI Session

Optional - On-campus neural reactivity assessment

During the two-week baseline period, participants reported craving and smoking via EMA (Ecological Momentary Assessment) using the LifeData RealLife Exp app multiple times per day while their geolocation was tracked to calculate tobacco retail exposure. The following four-week intervention period was designed to assess causal effects of exposure to tobacco retail.

Participants were randomly assigned to enter a tobacco retail store or a non-tobacco retail store once per day, or to follow their normal routines, while EMA and geolocation continued to be collected. Following the intervention period, eligible participants could opt into a fMRI session conducted at the University of Pennsylvania, designed to investigate neural reactivity to tobacco marketing cues.

Eligibility Criteria

Baseline Phase

✅ Inclusion Criteria

  • Ages 21-65 years
  • Smoke ≥5 cigarettes daily for past 6 months (urine cotinine concentration greater than 200 ng/mL)
  • Own iPhone or Android smartphone for daily use
  • Residents of Pennsylvania, New Jersey, or Delaware
  • Able to read and speak English fluently
  • Fully vaccinated against COVID-19

❌ Exclusion Criteria

  • Concurrent enrollment in smoking cessation programs
  • Plans to use nicotine substitutes within 3 months
  • Urine cotinine concentration below 200 ng/mL
  • Pregnancy
  • Refusal to install required mobile applications
  • Phone functionality inadequate for study tasks
  • Inability to upload Google Timeline data
  • Planned extended trips outside PA, NJ, DE during study

Intervention Phase

📊 Participation Requirements

Participants needed to respond to ≥75% of EMA prompts during the baseline period to continue to the intervention phase, and be willing to complete store visits.

Study Protocol Evolution: From study start until October 13, 2022, participants were excluded during the intervention period for non-compliance. On October 13, 2022, the study team moved to an intent-to-treat approach and did not exclude participants due to non-compliance once they began the intervention period.

fMRI Component

🧠 Neuroimaging Session

Participants who completed the baseline and intervention study components were eligible for the optional fMRI component, subject to additional screening criteria:

Medical & Substance Use Exclusions

  • Urine cotinine concentration below 200 ng/mL at scanning session
  • Current or recent (within 5 years) medical treatment for substance use disorder
  • Use of specified drugs within 2 weeks or plans to use within 6 weeks: Benzodiazepines, Amphetamines, Methamphetamines, Cocaine, MDMA, Methadone, Barbiturates, PCP, Heroin, Oxycodone, Opiates, Buprenorphine
  • Positive drug test at scan appointment

Neurological & Psychiatric Exclusions

  • Schizophrenia or psychosis (regardless of treatment status)
  • History of stroke or neurological disorder affecting cognition
  • Psychiatric hospitalization within the past year

MRI Safety & Scheduling Exclusions

  • Propensity to experience claustrophobia
  • Ferromagnetic metal in the body
  • Metal in the body of unverifiable origin
  • Non-removable piercings or dental work incompatible with fMRI
  • Orthopedic implants above the neck
  • Weight exceeding 350 pounds
  • Any medical condition compromising participant safety
  • Must be able to schedule scan within 6 months after completing the third Online Session

Recruitment

📢 Primary Recruitment Strategy

Recruitment materials for this study were primarily distributed by BuildClinical, utilizing study advertisements to engage participants on digital platforms such as Facebook, Google, and WebMD.

Recruitment Process

All recruitment materials included links (e.g., URLs, QR codes) directing potential participants to the study landing page at buildclinical.com/study/upenn-falk-smoking, which then directed them to complete the initial screening survey (Screen A) on the BuildClinical platform.

Screenshot from BuildClinical's website
Screenshot of a portion of BuildClinical's page for the study with a link to Screen A

🔄 Data Flow Process

  • Information collected via BuildClinical
  • Transferred securely to REDCap
  • Eligible participants automatically identified
  • Participants notified via text and email
  • Invited to schedule phone screening

👥 Referral Process

  • Some participants requested referral links
  • Direct link provided: redcap.link/georemote
  • Participants asked not to discuss study details
  • Privacy maintained until both completed participation

fMRI Recruitment: Enrolled or completed participants who were potentially eligible for the optional fMRI session were contacted to screen them for interest in and eligibility for the scan session.

📋 Multi-Stage Consent Process

Informed consent was collected at multiple stages throughout the study to ensure participants were fully informed at each phase of their involvement.

Stage 1

Screening Consent

Electronic consent form for screening collected during 'Screen B'

Stage 2

Full Study Consent

Electronic consent for full study participation collected during Online Session 1

Stage 3

fMRI Consent

Electronic consent for fMRI component collected at beginning of fMRI screening survey and scan session

Screening Phase: Participants eligible following Screen B were directed to Online Session 1, where they provided electronic consent to participate in the full study.

fMRI Component: Participants who completed the baseline and intervention components and who were interested in the fMRI component provided electronic consent at the beginning of the fMRI screening survey. Eligible participants who completed the fMRI scan provided additional consent at the beginning of the session.

Screening and Enrollment Process

Graphic of study timeline described below
The screening steps (top row) were all completed before participants consented to participate in the main study at the start of Online Survey Session 1, after which eligible participants continued to the main study tasks (bottom row).

📝 Screen A

Those who expressed interest in the study were directed toward an online screening survey (Screen A), administered via BuildClinical or REDCap.

Screen A Components:

Follow-up Process:

Initial Screening Call

📞 Call Preparation

  • Participants emailed copy of consent form
  • Study timeline provided for review
  • Scheduled via Calendly appointment system

🗣️ Call Components

  • Detailed study information provided
  • Risks and benefits discussion
  • Q&A opportunity
  • Eligibility criteria confirmation

Next Steps: Eligible and interested participants were invited via email to complete Screen B within 1 month of the initial call.

🔐 Screen B

Screen B began with an electronic consent form for the online screening survey and included several technical and verification components.

Required Components

Documentation:

Technical Setup:

COVID-19 Precautions: Vaccination was required because the pandemic was classified as a federal public health emergency when the study began, with extra precautions implemented to reduce risks during retail store visits.

Verification Process

Location Verification:

Vaccination Verification:

Exclusion Criteria at Screen B:

Data Protection: If individuals were found ineligible, the team informed them of ineligibility, deleted their geolocation data, and provided instructions for turning off location tracking and uninstalling Google Maps if desired.

📦 Mailing Materials

Eligible individuals were mailed a comprehensive box containing all necessary study materials.

Mailed Materials Included:

Upon Receipt: Participants received instructions to enroll in the study and begin participation by completing Online Session 1.

🖥️ Online Session 1

Comprehensive session administered over REDCap and Qualtrics, expected to take 30-60 minutes.

Session Components

Consent and Payment:

Assessments:

EMA Training:

Cotinine Verification

Final Eligibility Check: Participants uploaded a photograph of their urine cotinine test result. If results were not above the required threshold, participants were excluded from continuing in the study.

Screen A

Initial Interest

Online screening survey (<5 min)

Initial Call

Detailed Screening

Phone consultation with researcher

Screen B

Technical Setup

Location tracking, vaccination verification

Materials

Study Kit

Cotinine test, payment card, masks

Session 1

Full Enrollment

Consent, training, final verification

Baseline Period

📊 Baseline Data Collection

The baseline period began 2 days after completion of Online Session 1, and lasted for 14 days. During this period, participants completed EMA and location tracking to establish baseline smoking patterns.

Baseline Requirements

Duration: 14 days starting 2 days after Online Session 1

Data Collection:

Quality Assurance

📞 Participant Support

  • Participants contacted if no EMA surveys completed in first few days
  • Regular updates of % of surveys completed
  • Technical support as needed

🎯 Compliance Requirements

  • ≥75% EMA response rate required
  • Geolocation tracking must be active (verified through location history files)

Flexibility: Participants were able to pause their participation as needed (for example, due to significant illness or disruptive life events) at any point during the study.

Online Session 2

🖥️ Pre-Intervention Session

Participants completed Online Session 2 after the baseline period, with encouragement to complete within 1 week of invitation.

Session Components

Duration: 30-60 minutes via Qualtrics

Tasks Completed:

Image Rating Task

🖼️ Smoking Cue Reactivity Assessment

Participants viewed photographs and rated their craving response to assess reactivity to different types of smoking and retail cues.

Task Structure:

7 Categories each repeated 5 times

Categories 1-2: Standard Cues

1. Smoking cues: Cigarettes in a pack, in an ashtray, or alongside a lighter

2. Non-smoking cues: Pencils in a pack, with sharpener, or sitting on a table

Categories 3-4: Retail Environments

3. Non-tobacco retailers: Cash register areas at non-tobacco retailer stores

4. Tobacco retailers: Cash register and power wall area at tobacco retailer stores

Categories 5-7: Product Images

5. Cigarette packs: Close-up photographs of single brand cigarette packs

6. Promoted cigarettes: Single brand cigarette packs with price promotion features

7. Control products: Close-up photographs of gum packs with price promotion features

Personalization Features:

Pre-Task Assessment:

Additional Eligibility Screening

Store Visit Capability: Starting 10/06/2023, participants were asked if they could complete store visits (before knowing their assignment). Those unable to complete visits were excluded and compensated for completed tasks.

Random Condition Assignment

🎲 Randomization Procedure

Participants who completed baseline requirements were randomized using a blocked design to ensure balanced group assignment.

Randomization Strategy

Blocking Variables:

Implementation Timeline:

Study Conditions

Tobacco Retailer

Enter 7-11 stores that sell tobacco within study area (PA, DE, NJ)

Non-Tobacco Retailer

Enter CVS stores that do not sell tobacco within study area

Control

No store entry required, equal compensation, same other tasks

Intervention Period

🏪 4-Week Intervention Phase

The intervention period began after Online Session 2 completion, involving 4 weeks of condition-specific store visits alongside continued EMA and location tracking.

Universal Tasks (All Participants)

Duration: 4 weeks

Required Activities:

Store Visit Conditions

🏪 Store Visit Requirements

  • Frequency: 5 times per week for 4 weeks
  • Purchase requirement: Small purchase (excluding tobacco)
  • Budget: $3 per visit via Greenphire Clincard
  • Documentation: Receipt photo via RealLife Exp app

🎯 Store Assignments

  • Tobacco Retailer: Convenience stores selling tobacco
  • Non-Tobacco Retailer: Pharmacy stores not selling tobacco
  • Control: No store visits required
  • Compensation: Equal across all conditions

Online Session 3

📋 Post-Intervention Assessment

Following the Intervention Period, participants completed Online Session 3, encouraged to complete within 1 week of invitation. Two participants completed after longer delays.

Session Components

Tasks Completed:

Study Completion Procedures

📱 App Removal Instructions

  • Smartphone application uninstallation guidance
  • Location tracking deactivation instructions
  • Participant choice for data retention

📧 Non-Responder Protocol

  • Final payment sent after several contact attempts
  • Smoking cessation information provided
  • Study debriefing materials sent

Debriefing and Resources

Study Completion: Participants not interested in or eligible for fMRI received debriefing forms detailing study procedures and research goals, plus smoking cessation assistance information.

fMRI-Eligible Participants: Debriefing and cessation resources provided after scan completion or upon determination of scan ineligibility.

fMRI Session

🧠 Optional Neuroimaging Component

Participants who completed Online Session 3 and met eligibility criteria were invited for an optional 2-hour in-person fMRI session at the University of Pennsylvania.

Pre-Scan Procedures

Eligibility Confirmation:

Day of Scan Protocol:

Check-In

COVID-19 & Safety

University/hospital screening requirements, consent review

Pre-Scan

Final Verification

Urine sample, forms completion, surveys

Scanning

fMRI Session

Instructions, training, 1-hour scan protocol

fMRI Image Rating Task

🖼️ Neuroimaging Task Parameters

Enhanced version of the online image rating task, optimized for fMRI data collection.

Task Structure:

Image Categories (Same 7 as Online Task):

Repetition Structure

10 repetitions per category (vs. 5 in online task)

Each image repeated twice (vs. unique images online)

Categories 1-4

1. Smoking cues
2. Non-smoking cues
3. Non-tobacco retailers
4. Tobacco retailers

Categories 5-7

5. Cigarette packs
6. Promoted cigarettes
7. Control products (gum)

Additional Scanning Components

Anatomical Scans:

Technical Details: Complete scanning parameters can be found in Appendix: fMRI Scanning Parameters.

Session Summary

Session Breakdown: