Integrating Financial Coaching and Smoking Cessation Coaching
- Conditions
- Smoking
- Interventions
- Registration Number
- NCT05154669
- Lead Sponsor
- NYU Langone Health
- Brief Summary
This study conduct a two-arm, parallel-group randomized controlled trial. The study will recruit and randomize 900 smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling.
- Detailed Description
The study is a two-arm, parallel-group RCT. The study will recruit and randomize 900 low-income smokers (n=450 per arm) to either: (1) Control: Standard Smoking Cessation Counseling or (2) Intervention: Integrated Financial-Smoking Cessation Counseling. Both groups will receive 8 weeks of nicotine replacement therapy. The study will survey participants at baseline, 6 months, and 12 months to assess outcomes and mechanisms, and biochemically verify self-reported abstinence at 12 months (our primary outcome). The study will assess and compare the costs and cost-per-quit in the two treatment arms.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 299
- age ≥18 years,
- smokes ≥5 cigarettes per day,
- interested in receiving smoking and financial counseling,
- self-reported income below 200% of the current federal poverty level,
- New York City resident,
- speaks English or Spanish language (the interventions and measures have not been validated in other languages),
- able to provide informed consent, and
- does not have a representative who manages his/her funds.
Exclusion Criteria
- people who know a current past study participant (to avoid intervention contamination)
- People who have a medical contraindication to using nicotine replacement therapy:
- allergy to nicotine patch
- pregnancy or intention to become pregnant over the next 12 months
- breastfeeding
- heart attack in the past 2 months
- underlying arrhythmia
- ongoing or worsening angina.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Smoking Cessation Coaching Nicotine Replacement Therapy Agent - Patches Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). Integrated Financial-Smoking Cessation Coaching Nicotine Replacement Therapy Agent - Patches The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). Integrated Financial-Smoking Cessation Coaching Nicotine Replacement Therapy Agent - Lozenges The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). Standard Smoking Cessation Coaching Nicotine Replacement Therapy Agent - Gum Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). Standard Smoking Cessation Coaching Nicotine Replacement Therapy Agent - Lozenges Participants will receive 5 counseling sessions over approximately 8 weeks as per standard smoking cessation programs. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). Integrated Financial-Smoking Cessation Coaching Financial counseling The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges). Integrated Financial-Smoking Cessation Coaching Nicotine Replacement Therapy Agent - Gum The integrated intervention will provide 5 counseling sessions over approximately 8 weeks that integrates financial coaching into the smoking cessation program. Participants will receive 8 weeks of nicotine replacement therapy (patches, gum, and/or lozenges).
- Primary Outcome Measures
Name Time Method Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (salivary cotinine) 12 months The study will collect salivary cotinine from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a saliva collection kit supplied by Salimetrics Inc. Participants will be classified as negative for salivary cotinine if their concentration is \<10ng/ml,
Effectiveness of the integrated intervention to standard cessation counseling on long-term abstinence (CO concentration) 12 months The study will collect exhaled CO from participants reporting 7-day abstinence from cigarettes on the 12-month survey. The study will use a coVita Co monitor that provides an immediate CO concentration reading in single parts per million (ppm). Participants will be classified as negative for exhaled CO if their concentration is \<8 ppm.
- Secondary Outcome Measures
Name Time Method Change in quit attempts 6 and 12 months Measured with self reported survey regarding attempts to quit smoking at 6 months and at 12 months
Change in self-reported abstinence from cigarettes 6 and 12 months Measured with self-reported abstinence from cigarettes at 6 months and at 12 months
Change in self-reported use of electronic nicotine delivery systems use 6 and 12 months Measured with self-reported use of electronic nicotine delivery systems use at 6 months and at 12 months
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States