Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral + Nicotine Patch | Experimental | Cognitive Behavioral Therapy + Nicotine Replacement Patch |
|
| Health Education + Nicotine Patch | Active Comparator | Health Education + Nicotine Replacement Patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Post-treatment (12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change | % Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100 | Post-treatment (12 weeks) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marney A White, PhD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Treatment + Nicotine Replacement | Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks |
| FG001 | Health Education + Nicotine Replacement | Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Behavioral Treatment + Nicotine Replacement | Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks |
| BG001 | Health Education + Nicotine Replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | participants | Post-treatment (12-weeks) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Treatment + Nicotine Replacement | Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marney A. White | Yale University School of Medicine | 203-785-4349 | marney.white@yale.edu |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent Weight Change | % Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100 | Posted | Mean | Standard Deviation | Percent weight change | Post-treatment (12 weeks) |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Health Education + Nicotine Replacement | Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks | 0 | 27 | 0 | 27 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |