Status:
UNKNOWN
Treating Adults at Risk for Weight Gain With Interactive Technology
Lead Sponsor:
University of Tennessee
Conditions:
Smoking
Body Weight
Eligibility:
All Genders
18-35 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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:
- \*18 to 35 years old
- BMI \> 22 kg / m2
- Self report smoking \> 10 cigarettes each day
- Have access to a telephone and the internet
- Demonstrate ability to access a specific web site
- Demonstrate ability to receive and respond to email
- Willing to accept random assignment
- \*Intending to be available for a 24 month intervention
- \*At risk for weight gain (e.g. plan to quit smoking)
Exclusion
- Persons will be excluded from the TARGIT study for the following:
- \*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
- 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)
- \*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
- Current substance abuse (includes alcohol use in excess of 21 drinks a week)
- Uncontrolled hypertension as defined as BP \> 140/90 mm Hg
- Presence of an unstable psychiatric condition or use of anti-psychotic drugs
- History of significant kidney disease or liver disease
- History of uncontrolled thyroid disease or pheochromocytoma
- 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
- Severe uncontrolled asthma, bronchitis, or emphysema that precludes exercise
- Resting heart rate \> 100
- \*Malignancy in the last 5 years (except non-melanoma skin cancer)
- Plans to move from the Memphis metropolitan area in the next two years
- Current participation in another clinical trial
- \*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
- \*History of diabetes treated with a medication that may cause hypoglycemia such as insulin or an oral hypoglycemic agent
- 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 or \> 40 kg / m2
- \*Have a household member on study staff
- \*Current treatment for an eating disorder
- \*Unable to provide informed consent
- \*Regular use of a systemic steroids defined as taking the medication most days of the week
- \*Use of medications to treat attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01199185
Start Date
August 1 2009
End Date
October 1 2014
Last Update
June 18 2013
Active Locations (1)
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1
Department of Preventive Medicine
Memphis, Tennessee, United States, 38163