Obesity, Overweight, Smoking Cessation
Conditions
Keywords
Smoking cessation, Overweight, Obesity, Internet treatment
Brief summary
This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.
Interventions
DRUGNicotine patch
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
Sponsors
American Heart Association
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Smoking 10 or more cigarettes per day * Regular access to the internet * BMI\>=25
Exclusion criteria
* Type I diabetes or Type II diabetes requiring medication * Alcohol or drug dependence within the past year * Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months * Uncontrolled hypertension * Severe chronic obstructive pulmonary disease * Use of an investigational drug within 30 days or current participation in another clinical trial * Current use of tobacco products other than cigarettes or use of marijuana * Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment * Use of a medication that might affect weight or appetite * History of allergic reactions to adhesives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Verified Smoking Cessation (Abstinence) | Post-treatment (12-weeks) | Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change | Post-treatment (12 weeks) | % Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) \* 100 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Treatment + Nicotine Replacement Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks | 27 |
| Health Education + Nicotine Replacement Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 9 |
Baseline characteristics
| Characteristic | Health Education + Nicotine Replacement | Cognitive Behavioral Treatment + Nicotine Replacement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 54 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 9.6 | 46.4 years STANDARD_DEVIATION 11.6 | 45.9 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
Number of Participants With Verified Smoking Cessation (Abstinence)
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level \<10ppm)
Time frame: Post-treatment (12-weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitive Behavioral Treatment + Nicotine Replacement | Number of Participants With Verified Smoking Cessation (Abstinence) | 7 participants |
| Health Education + Nicotine Replacement | Number of Participants With Verified Smoking Cessation (Abstinence) | 5 participants |
Secondary
Percent Weight Change
% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) \* 100
Time frame: Post-treatment (12 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Treatment + Nicotine Replacement | Percent Weight Change | 1.47 Percent weight change | Standard Deviation 2.9 |
| Health Education + Nicotine Replacement | Percent Weight Change | 1.79 Percent weight change | Standard Deviation 2.8 |