Karen C. Johnson, MD, MPH
Phyllis Richie, PhD
Mace Coday, PhD
Fran Tylavsky, PhD
Robert Klesges, PhD
Fridtjof Thomas, PhD
Catherine Womack, MD
August 25, 2011
University of Tennessee Health Science Center
Department of Preventive Medicine
Margaret Sularin, Project Manager
Margaret Caufield, Recruitment Manager
Sarah Terrell, Nutrition, Tech Support
Christie White, Behavioral Counseling
Jenn Fournier, Exercise Science
Caiquin Liu, Data Base
Aron Katz, PhD candidate in Psychology
John Sawyer, PhD in Psychology
Kate Flynn, PhD candidate
Jan Elam and Beate Griffin, Administrative
University of Tennessee Health Science Center
Department of Preventive Medicine
Background
 Prevalence of overweight and obesity in Tennessee
Tennessee > 67%
African Americans > 79%
Persons age 18-24 > 42%
Persons age 25-34 > 65%
 Memphis, TN is often rated as one of the most obese
and most sedentary cities in the United States.
 Prevalence of Cigarette Smoking
24.3% in Tennessee v. to 19.8% in the US
Background
 Average post-cessation weight gain is 5-6 kg
 9.7 kg weight gain over five years
 Concerns about body weight often predict smoking relapse
 Fear about weight gain can diminished interest in
smoking cessation
Primary Aim
To test whether an efficacious proactive tobacco
quit line plus a behavioral weight loss intervention
delivered through interactive technology
(Intervention Group) will significantly attenuate or
prevent weight gain associated with smoking
cessation at 2 years after enrollment compared to a
tobacco quit line alone (Comparison Group) in
young adult smokers with a BMI > 20 kg/m2.
Secondary Aims
To assess at baseline and follow ups:
• Biochemically verified smoking cessation
• Eating behavior
• Physical activity and sedentary behavior
TARGIT is a randomized clinical trial
TARGIT is part of a cooperative group
called EARLY (Early Adult Reduction of weight through
LifestYle intervention)
Inclusion Criteria
TARGIT will be open to all persons of any gender or race
who are:
1) *18 to 35 years old
2) BMI > 20 kg / m2
3) Self report smoking > 10 cigarettes each day
4) Have access to a telephone and the internet
5) Demonstrate ability to access a specific web site
6) Demonstrate ability to receive and respond to e-mail
7) Willing to accept random assignment
8) *Intending to be available for a 24 month intervention
9) *At risk for weight gain (e.g. plan to quit smoking)
* Denotes eligibility criteria that are common among Early Sites.
Exclusion Criteria
Persons will be excluded from the TARGIT study for the following:
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*Current participation in a commercial weight loss program
Currently meet recommendations for physical activity
Current substance abuse
Presence of an unstable psychiatric condition or use of anti- psychotic drugs
Current use of a medication that may interfere with primary study endpoints
or that may increase the risk of side effects from the study intervention that
can not be discontinued
Plans to move from the Memphis metropolitan area in next two yrs.
Current participation in another clinical trial
Known allergy or sensitivity to the nicotine patch
*Currently pregnant or gave birth within the last 6 months, currently lactating
or breast feeding within the last 3 months, actively planning pregnancy
within the next 24 months
*BMI < 18.5 kg / m2
*Current treatment for an eating disorder
*Unable to provide informed consent
Recruitment Strategies
MEDIA COVERAGE
PRINT
INTERNET
COMMUNITY EVENTS
WORD OF MOUTH
Recruitment
Print materials
Business Card
Rack Card
Postcard
Flyer
TV Advertisement
Clinic Visit Schedule
Screening Visit (SV)
Randomization Visit (RV)
Group 1 (Intervention)
Group 2 (Comparison)
1 wk technology visit (1 wk)
1 wk technology visit (1 wk)
6 month follow-up visit (6 m)
6 month follow-up visit (6 m)
12 month follow-up visit (12 m)
12 month follow-up visit (12 m)
24 month follow-up visit (24 m)
24 month follow-up visit (24 m)
Comparison Group
Tobacco Quitline - Proactive
Nicotine Patches
Ipod Touch
 Apps
Website http://www.targitstudy.org
 Smoking Cessation
Intervention Group
Tobacco Quitline
Webinar Group Sessions
Nicotine Patches
Interventionist Contact
 Phone, e-mail, texts
Ipod Touch
 Apps
Website
 Smoking Cessation
 Weight Loss
Study Measures
• Weight / Height*
• Smoking
– Self Report*
– Exhaled Carbon Monoxide
– Salivary Cotinine
• Diet*
– Diet History Questionnaire
– Eating Away from Home
– Daily Meal Patterns
– Dieting Behaviors
*Denotes common
measures for all Early Sites
Study Measures
• Physical Activity*
– Paffenbarger
– Sedentary Behavior
• Other Questionnaires*
– Neighorhood Environment
– Alcohol
– CES-D
– Sleep
*Denotes common
measures for all Early Sites
Study Measures
• Vital Signs (BP, etc)*
• Waist / Hip Circumference*
• Adverse Events*
• Sociodemographics*
• Medication Use
• Contact information
• Urine Pregnancy Test
*Denotes common
measures for all Early Sites
iPod Touch
Internet
Calendar
Email
Podcast
Apps
TARGIT Apps for Both Groups
TARGIT
iRelax
TARGIT Apps for Intervention Group
Cisco WebEx
Lose It!
Restaurants
I Workout Lite
All Recipes
Lose It! App
Restaurants App
All Recipes App
All Recipes App
Cisco WebEx
TARGIT Smoking Cessation App
iRelax Lite App
iRelax Lite
Sample Podcast
Targit Website and Study DBMS Data
Collection & Processing
Visit information pushed to
Information submitted
uthsc.edu Oracle DBMS is
online through Targit
available for participants to
website is stored in
view at personalized
uthsc.edu Oracle DBMS
myTargit website
Web information pulled from
Oracle
study DBMS
Visit &into
intervention
hosted
on FileMaker
information
pushedServer
to
Oracle from study DBMS
Research staff uses
participantstaff
submitted
Research
collects
information
for recruitment
participant data
during
and study
clinic
visitsintervention
& intervention
delivery & enters into
study DBMS
Automated Participant Interface (API)
Data Processing
Participant questionnaire data
completed & submitted online
via web-based API is stored in
uthsc.edu Oracle DBMS
API data pulled from Oracle into
Data Review DBMS hosted on
FileMaker Server
Research staff reviews
participant data for
completeness in Review DBMS
Research staff approves
reviewed participant data
and submits to Targit DBMS
Safety Monitoring
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Informed Consent
On call system
Manual of Operations
Computerized tracking
Adverse event questionnaire
Institutional Review Board
Data Safety Monitoring Board
Timeline
Phase II Clinical Trial
Recruitment
Intervention Delivery
Clinic Follow-up Visits
08/2010 – 02/2012
08/2010 – 02/2014
02/2011 – 02/2014
Close-out, Analysis of Data,
Manuscript Preparation,
Dissemination of Results
03/2014 – 08/2014
Dissemination Plans
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Newsletter to participants
Publication and presentation of results
Press release
Group cooperative publications
De-identified dataset for public release
Intervention documentation
Questions