Try our beta test site

Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amanda L. Graham, PhD, Truth Initiative
ClinicalTrials.gov Identifier:
NCT01544153
First received: February 28, 2012
Last updated: December 19, 2016
Last verified: December 2016
Results First Received: October 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Behavioral: WEB
Behavioral: Social Network
Behavioral: Nicotine Replacement Therapy (NRT)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
WEB Only

Control group receiving no additional intervention

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

WEB+SN

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

WEB+NRT

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.

WEB+SN+NRT

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.


Participant Flow:   Overall Study
    WEB Only   WEB+SN   WEB+NRT   WEB+SN+NRT
STARTED   1337   1324   1314   1317 
COMPLETED   1337   1323   1313   1317 
NOT COMPLETED   0   1   1   0 
Under 18                0                1                0                0 
Non-smoker                0                0                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes baseline characteristics of participants who completed participation in the full study.

Reporting Groups
  Description
WEB Only

Control group receiving no additional intervention

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

WEB+SN

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

WEB+NRT

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.

WEB+SN+NRT

WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.

Total Total of all reporting groups

Baseline Measures
   WEB Only   WEB+SN   WEB+NRT   WEB+SN+NRT   Total 
Overall Participants Analyzed 
[Units: Participants]
 1337   1323   1313   1317   5290 
Age, Customized 
[Units: Participants]
Count of Participants
         
< 18 years   0   0   0   0   0 
18-24 years old   131   128   140   149   548 
25-44 years old   573   615   601   606   2395 
45-64 years old   567   522   522   510   2121 
>=65 years   66   58   50   52   226 
Gender, Customized 
[Units: Participants]
Count of Participants
         
Female      822  61.5%      809  61.1%      788  60.0%      798  60.6%      3217  60.8% 
Male      515  38.5%      514  38.9%      525  40.0%      519  39.4%      2073  39.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      34   2.5%      18   1.4%      29   2.2%      33   2.5%      114   2.2% 
Asian      14   1.0%      25   1.9%      17   1.3%      26   2.0%      82   1.6% 
Native Hawaiian or Other Pacific Islander      13   1.0%      14   1.1%      14   1.1%      14   1.1%      55   1.0% 
Black or African American      216  16.2%      193  14.6%      209  15.9%      184  14.0%      802  15.2% 
White      1060  79.3%      1073  81.1%      1044  79.5%      1060  80.5%      4237  80.1% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      80   6.0%      82   6.2%      61   4.6%      71   5.4%      294   5.6% 
Not Hispanic or Latino      1257  94.0%      1241  93.8%      1252  95.4%      1246  94.6%      4996  94.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   1337   1323   1313   1317   5290 
Education 
[Units: Participants]
Count of Participants
         
Some High School or Less   66   57   59   65   247 
High School Graduate   319   279   293   309   1200 
Some College   643   672   658   658   2631 
College Graduate   309   315   303   285   1212 
Unknown or Not Reported   0   0   0   0   0 
Employment 
[Units: Participants]
Count of Participants
         
Employed Full-Time   597   614   608   583   2402 
Not Employed Full-Time   740   709   705   734   2888 
Unkown or Not Reported   0   0   0   0   0 
Marital Status 
[Units: Participants]
Count of Participants
         
Has a Partner   695   714   665   661   2735 
No Partner   642   609   648   656   2555 
Unknown or Not Reported   0   0   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-reported 30-day Point Prevalence Abstinence   [ Time Frame: 9 months post-randomization ]

2.  Secondary:   Self-reported 30-day Point Prevalence Abstinence   [ Time Frame: 3 months post-randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Amanda L. Graham, PhD
Organization: Truth Initiative
phone: 202-454-5938
e-mail: agraham@truthinitiative.org


Publications:

Responsible Party: Amanda L. Graham, PhD, Truth Initiative
ClinicalTrials.gov Identifier: NCT01544153     History of Changes
Other Study ID Numbers: 1R01CA155489 ( US NIH Grant/Contract Award Number )
Study First Received: February 28, 2012
Results First Received: October 25, 2016
Last Updated: December 19, 2016