Strategies to Reduce Weight Gain in Hypertensive Smokers
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|ClinicalTrials.gov Identifier: NCT00119821|
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Hypertension Obesity||Behavioral: Weight Reducing Diet Behavioral: Exercise Behavioral: Smoking Cessation||Not Applicable|
Obesity and smoking are major risk factors for a variety of health-related disorders, such as heart disease, stroke, certain forms of cancer, and diabetes. Recently, it has been reported that up to 65 percent of adults in the United States are overweight or obese. The increasing epidemic of obesity has led to many initiatives to treat obesity and to a number of recent initiatives to prevent weight gain. Similarly, the prevalence of smoking has not declined in the past few years, despite the availability of several clinically and cost-effective smoking cessation programs. One unwanted effect of smoking cessation is weight gain, which, in turn, may exacerbate weight-related health issues. Behavioral programs, and to a lesser degree pharmacological programs, designed to reduce post-cessation weight gain have been successful. However, given that this weight gain is typically cosmetic, it has been determined that such programs should be targeted to those at a higher medical risk as a result of the weight gain (e.g., individuals with hypertension). To our knowledge, no study has evaluated a smoking cessation program, followed by a lifestyle modification program, to prevent weight gain among those placed at medical risk by the post-cessation weight gain, including individuals with hypertension. Some studies find an increased prevalence of hypertension following smoking cessation. It is believed that this is largely (but not solely) due to weight gain following cessation. However, any weight gain in individuals with hypertension places them at risk. Body weight is the single best predictor of adult blood pressure, and blood pressure responds to very small changes in overall body weight.
This study will recruit 660 smokers with hypertension or elevated blood pressure. Given that African Americans are at high risk for both post-cessation weight gain and hypertension, the majority of participants recruited will be African American. Participants will be randomly assigned to either of the following: (a) a validated smoking cessation program followed by a validated weight control program (TONE), which consists of changes in dietary intake and physical activity; or (b) the same smoking cessation program followed by a general health education (contact-time control) program. A follow-up evaluation will occur 1 year following the end of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||459 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Weight Gain Prevention in Hypertensive Smokers|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2011|
Behavioral Weight Reduction
Behavioral: Weight Reducing Diet
Moderate exercise implemented plus behavioral intervention.
Behavioral: Smoking Cessation
Nicotine Patch in dosages given based on number of cigarettes per day smoked. 21 mg patch, 14 mg patch, 7 mg patch for total of 6 weeks duration of therapy.
NRT gum is being provided to assist with relapse prevention. At the randomization visit the participant is given one (1) box of 2mg NRT gum, which consists of (110) pieces. The participant may request up to two (2) more boxes, for a maximum of three (3) boxes per participant.
- Smoking cessation rates [ Time Frame: Measured at 1 year ]
- Body weight changes [ Time Frame: Measured at 1 year ]
- Changes in dietary intake [ Time Frame: Measured at 1 year ]
- Changes in physical activity [ Time Frame: Measured at 1 year ]
- Changes in blood pressure and hypertensive status [ Time Frame: Measured at 1 year ]
- Changes in blood pressure medication status [ Time Frame: Measured at 1 year ]
- Changes in salt intake [ Time Frame: Measured at 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119821
|Study Chair:||Robert C. Klesges, PhD||University of Tennessee Center for Health Sciences|