Treating Adults at Risk for Weight Gain With Interactive Technology

Smoking Clinical Trial

— TARGIT  

Official title:

Targeted Approaches to Weight Control for Young Adults

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01199185
• Other study ID #: 1U01HL096628
• Status: Unknown status
• Phase: Phase 3
• First received: September 9, 2010
• Last updated: June 17, 2013
• Start date: August 2009
• Est. completion date: October 2014

Study information

• Verified date: June 2013
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented.

Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults.

If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 330
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

The selection criteria for the clinical trial are designed to include a wide range of participants such that the study sample will be representative of the broader U.S. population of the Memphis metropolitan area. Those who might be at risk of adverse outcomes from the study interventions will be excluded (see exclusion criteria). All participants will give voluntary consent at the screening visit by signing an informed consent statement which has been approved by the Institutional Review Board (IRB). We will encourage the participation of women and minorities. The study will be open to all persons of any race or gender who are:

1. *18 to 35 years old

2. BMI > 22 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 email

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)

Exclusion Criteria:

Persons will be excluded from the TARGIT study for the following:

1. *Current participation in a commercial weight loss program (e.g. Weight Watchers, Jenny Craig, etc.), current use of a prescription weight loss medication, planned weight loss surgery within the next 24 months (e.g. gastric bypass, lap band, or liposuction), current or planned enrollment in another diet / physical activity / weight loss study

2. Currently meet recommendations for physical activity (i.e., 30 minutes or more of moderate physical activity per day on the majority of days each week - 150 minutes or more each week)

3. *History of cerebral, coronary, or peripheral vascular disease, or serious uncontrolled cardiac arrhythmia, revascularization procedure or uncontrolled congestive heart failure in the past 6 months

4. Current substance abuse (includes alcohol use in excess of 21 drinks a week)

5. Uncontrolled hypertension as defined as BP > 140/90 mm Hg

6. Presence of an unstable psychiatric condition or use of anti-psychotic drugs

7. History of significant kidney disease or liver disease

8. History of uncontrolled thyroid disease or pheochromocytoma

9. Current use of a medication that may interfere with primary study endpoints (e.g. a weight loss medication such as Orlistat, etc) or that may increase the risk of side effects from the study intervention that can not be discontinued

10. Severe uncontrolled asthma, bronchitis, or emphysema that precludes exercise

11. Resting heart rate > 100

12. *Malignancy in the last 5 years (except non-melanoma skin cancer)

13. Plans to move from the Memphis metropolitan area in the next two years

14. Current participation in another clinical trial

15. *Other medical or behavioral factors, that in the judgment of the Principal Investigator, may interfere with study participation or the ability to follow the intervention protocol

16. *History of diabetes treated with a medication that may cause hypoglycemia such as insulin or an oral hypoglycemic agent

17. Known allergy or sensitivity to the nicotine patch

18. *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

19. *BMI < 18.5 kg / m2 or > 40 kg / m2

20. *Have a household member on study staff

21. *Current treatment for an eating disorder

22. *Unable to provide informed consent

23. *Regular use of a systemic steroids defined as taking the medication most days of the week

24. *Use of medications to treat attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)

Related Conditions & MeSH terms

• Body Weight
• Smoking

Intervention

Behavioral:
• Smoking Cessation
All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT).
• Smoking Cessation plus Weight Loss
All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT). Participants in the Intervention Group will also receive a Behavioral Weight Loss/ Weight Gain Prevention Intervention delivered via interactive technology. The Intervention group will receive 16 weekly webinar sessions beginning 7 weeks after randomization via Cisco WebEx. The webinar sessions will present the behavioral weight loss/ weight gain prevention program. After the 16 weekly sessions, the webinar sessions will then be scheduled monthly for the next 6 months then quarterly thereafter for 12 months.

Locations

Country	Name	City	State
United States	Department of Preventive Medicine	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		24 months after randomization
Secondary	Smoking status		24 months after randomization

External Links

•   TARGIT study website