Smoking Clinical Trial
Official title:
Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity
NCT number | NCT02873754 |
Other study ID # | Pro00074576 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | July 2017 |
Verified date | June 2018 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and increase physical activity among low-income persons. The intervention is called Smoking Treatment and Exercise Program for Underserved Populations (STEP UP).
Status | Completed |
Enrollment | 11 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - current household income less than twice the federal poverty guidelines (Finer & Henshaw, 2006; for instance, someone from a family of 4 must have a household income less than $48,500 to be eligible) - currently smoke >10 cigarettes a day - smoking for at least the past year - can speak and write fluent conversational English - are 18-70 years of age - are willing to make an attempt to quit smoking and increase physical activity Exclusion Criteria: - inability to walk - expected to have unstable medication regimen during the study - currently receiving non-study behavioral treatment for smoking - myocardial infarction in the past 6 months - contraindication to nicotine replacement therapy (NRT) or bupropion with no medical clearance - exclusive use of other forms of nicotine such as cigars, pipes, e-cigarettes, or chewing tobacco - current pregnancy - current imprisonment or psychiatric hospitalization |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Who Self-report Prolonged Abstinence From Smoking | Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit. | 6 month follow up | |
Primary | Number of Participants Whose Prolonged Abstinence is Bio-verified | Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit. | 6 month follow up | |
Primary | Number of Participants Who Self-report Prolonged Abstinence From Smoking | Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit. | 3 month follow up | |
Primary | Number of Participants Whose Prolonged Abstinence is Bio-verified | Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit. | 3 month follow up | |
Secondary | Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking | 7-day point prevalence abstinence is defined as no smoking in the prior 7 days. | 6 month follow up | |
Secondary | Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking | 30-day point prevalence abstinence is defined as no smoking in the prior 30 days. | 6 month follow up | |
Secondary | Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking | 7-day point prevalence abstinence is defined as no smoking in the prior 7 days. | 3 month follow up | |
Secondary | Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking | 30-day point prevalence abstinence is defined as no smoking in the prior 30 days. | 3 month follow up | |
Secondary | Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale. | Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline). | baseline and 3 month follow up | |
Secondary | Change in the Number of Days in Which Smoked Compared to Pre-quit Use | Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit. | 3 month follow up | |
Secondary | Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit | Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date | 3 month follow up | |
Secondary | Number of Quit Smoking Attempts | Participants will self-report the number of quit attempts they've had since baseline. | 3 month follow up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02649556 -
A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2
|
N/A | |
Completed |
NCT03901066 -
Smoking Dependence and Periodontitis
|
||
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT03170752 -
Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)
|
N/A | |
Completed |
NCT03305978 -
Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.
|
N/A | |
Completed |
NCT00000437 -
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
|
Phase 4 | |
Completed |
NCT06105424 -
BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
|
N/A | |
Active, not recruiting |
NCT02752022 -
Monitoring the Transition From Smoking to E-cigarettes
|
||
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02901171 -
The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation
|
N/A | |
Completed |
NCT04340830 -
The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants
|
N/A | |
Completed |
NCT02912000 -
TEACH: Technology Evaluation to Address Child Health
|
N/A | |
Completed |
NCT02949648 -
Electronic Cigarette Use and Quitting in Youth
|
N/A | |
Completed |
NCT02246114 -
Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women
|
N/A | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT02008292 -
Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors
|
N/A | |
Completed |
NCT01898507 -
Nicotine Metabolism and Low Nicotine Cigarettes
|
N/A | |
Completed |
NCT01954407 -
Young Adults' Responses to Anti-smoking Messages
|
N/A |