Obesity and Obesity-related Medical Conditions, Smoking Cessation
Conditions
Keywords
obesity, electronic cigarettes, harm reduction
Brief summary
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
Detailed description
The purpose of this study is to provide preliminary information on the effect of electronic cigarettes (EC) and nicotine replacement therapy (NRT) among SWO. This study will randomize up to 60 individuals who smoke cigarettes with comorbid obesity (SWO) to receive (1) electronic cigarettes (EC), (2) nicotine replacement therapy (NRT), or 3) a no-product control (CON) condition for 8 weeks. Assessments will occur at baseline, and 1, 2, and 3-months follow-up, aiming: 1) To compare EC, NRT, and CON on smoking, exhaled carbon monoxide, and number of quit attempts; 2) To compare EC and NRT on acceptability and adherence; 3) To compare EC, NRT, and CON effects on weight, central adiposity, glucose regulation, inflammation, cotinine, and blood pressure at follow-up.
Interventions
OTHERElectronic Cigarettes (EC)
Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to EC for 8 weeks, with EC provided.
OTHERNicotine replacement therapy (NRT)
Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to combination NRT (transdermal + oral) for 8 weeks, with NRT provided.
Sponsors
Brown University
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will not know the outcome of randomized assignment.
Intervention model description
A 3-group design.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* body mass index (BMI) ≥ 30 kg/m2 (i.e., obese) * smoked ≥ 5 cigarettes/day during the past year * 21 or older (due to minimum legal age EC restrictions) * exhaled breath carbon monoxide (CO) level \> 6 ppm at Baseline (BL) (to confirm self-reported smoking) * willing to use EC or NRT for 8 weeks * access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)
Exclusion criteria
* received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking), * currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products) * hospitalized for mental illness in past 30 days * heart-related event (e.g., heart attack, severe angina) in past 30 days * residing with another person currently enrolled in the study * pregnant, nursing, or planning to become pregnant in the next 6 months * medical contraindication for study or product use (e.g., allergy to adhesives) * taken prescription weight loss medication in the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of cigarettes per day | 2 months | Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments. |
| carbon monoxide (CO) | 2 months | Exhaled breath sample used to measure carbon monoxide |
| number of quit attempts | 2 months | Number of attempts to quit smoking during the experimental period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| product acceptability | 2 months | Self-rated acceptability (e.g., satisfaction) of the alternative nicotine product assigned (if applicable) |
| product adherence | 2 months | Percentage of days using the alternative nicotine product assigned (if applicable) |
| change in weight | 2 months | change in body weight (lbs) from baseline to 2 months |
| change in waist circumference | 2 months | change in waist circumference, a measure of central adiposity, from baseline to 2 months |
| A1c | 2 months | level of A1c, measured via blood sample, as a measure of glucose regulation |
| interleukin-6 (IL-6) | 2 months | level of IL-6, measured via blood sample, as a measure of inflammation |
| cotinine | 2 months | level of cotinine, measured via blood sample, as a measure of nicotine exposure |
| diastolic blood pressure | 2 months | diastolic blood pressure measured using a cuff |
| systolic blood pressure | 2 months | systolic blood pressure measured using a cuff |
Countries
United States
Contacts
CONTACTCRESCENT Study Research Staff
Outcome results
None listed