Presentation is loading. Please wait.

Presentation is loading. Please wait.

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,

Similar presentations


Presentation on theme: "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,"— Presentation transcript:

1 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

2 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

3  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

4  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 Background

5 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/m 2. Primary Aim

6 To assess at baseline and follow ups: Biochemically verified smoking cessation Eating behavior Physical activity and sedentary behavior Secondary Aims

7  TARGIT is a randomized clinical trial  TARGIT is part of a cooperative group called EARLY (Early Adult Reduction of weight through LifestYle intervention)

8 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. Inclusion Criteria

9 Persons will be excluded from the TARGIT study for the following:  *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 Exclusion Criteria

10 MEDIA COVERAGE PRINT INTERNET COMMUNITY EVENTS WORD OF MOUTH Recruitment Strategies

11 Print materials Business Card Recruitment

12 Rack Card

13 Postcard

14 Flyer

15 TV Advertisement

16 Screening Visit (SV) Randomization Visit (RV) Group 1 (Intervention) Group 2 (Comparison) 1 wk technology visit (1 wk)6 month follow-up visit (6 m)12 month follow-up visit (12 m)24 month follow-up visit (24 m) Clinic Visit Schedule

17 Tobacco Quitline - Proactive Nicotine Patches Ipod Touch  Apps Website http://www.targitstudy.orghttp://www.targitstudy.org  Smoking Cessation Comparison Group

18 Tobacco QuitlineWebinar Group Sessions Nicotine PatchesInterventionist Contact  Phone, e-mail, texts Ipod Touch  Apps Website  Smoking Cessation  Weight Loss Intervention Group

19 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

20 Study Measures Physical Activity* –Paffenbarger –Sedentary Behavior Other Questionnaires* –Neighorhood Environment –Alcohol –CES-D –Sleep *Denotes common measures for all Early Sites

21 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

22 iPod Touch Internet Calendar Email Podcast Apps

23 TARGIT Apps for Both Groups iRelax TARGIT

24 TARGIT Apps for Intervention Group Lose It! Cisco WebEx Restaurants I Workout Lite All Recipes

25 Lose It! App

26 Restaurants App

27 All Recipes App

28

29 Cisco WebEx

30 TARGIT Smoking Cessation App

31 iRelax Lite iRelax Lite App

32

33

34

35

36

37 Sample Podcast

38 Targit Website and Study DBMS Data Collection & Processing Information submitted online through Targit website is stored in uthsc.edu Oracle DBMS Web information pulled from Oracle into study DBMS hosted on FileMaker Server Research staff uses participant submitted information for recruitment and study intervention Research staff collects participant data during clinic visits & intervention delivery & enters into study DBMS Visit & intervention information pushed to Oracle from study DBMS Visit information pushed to uthsc.edu Oracle DBMS is available for participants to view at personalized myTargit website

39 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

40 Safety Monitoring Informed Consent On call system Manual of Operations Computerized tracking Adverse event questionnaire Institutional Review Board Data Safety Monitoring Board

41 Timeline Phase II Clinical Trial Recruitment 08/2010 – 02/2012 Intervention Delivery 08/2010 – 02/2014 Clinic Follow-up Visits02/2011 – 02/2014 Close-out, Analysis of Data, Manuscript Preparation, Dissemination of Results03/2014 – 08/2014

42 Dissemination Plans Newsletter to participants Publication and presentation of results Press release Group cooperative publications De-identified dataset for public release Intervention documentation

43 Questions

44


Download ppt "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,"

Similar presentations


Ads by Google