NCT01923467

Brief Summary

This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance. In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are: Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program. Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer. Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
767

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 15, 2015

Completed
Last Updated

June 15, 2015

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

August 13, 2013

Results QC Date

May 29, 2015

Last Update Submit

May 29, 2015

Conditions

Keywords

smokingnicotine replacementinternet

Outcome Measures

Primary Outcomes (1)

  • Acceptance of Offer to Join Stop Smoking Program

    After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.

    1 Day of Enrollment

Study Arms (1)

Project Quit plus NRT patches

EXPERIMENTAL

All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.

Behavioral: Project Quit stop smoking programDrug: Nicotine patches 21 mg

Interventions

This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.

Project Quit plus NRT patches

Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.

Also known as: Nicoderm CQ Step 1 (21 mg)
Project Quit plus NRT patches

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current smoker

You may not qualify if:

  • Current participation in another stop-smoking program
  • Current use of stop smoking medications
  • Pregnant or breastfeeding
  • Limited internet or email access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Communications Research, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Larry An, MD
Organization
University of Michigan

Study Officials

  • Lawrence C An, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 15, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 15, 2015

Results First Posted

June 15, 2015

Record last verified: 2014-12

Locations