Strategies to Reduce Weight Gain in Hypertensive Smokers
NCT00119821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 459
Last updated 2015-12-02
Summary
To evaluate the effectiveness of lifestyle modification following a smoking cessation program in preventing weight gain among hypertensive smokers placed at medical risk by the post-cessation weight gain.
Conditions
- Cardiovascular Diseases
- Heart Diseases
- Hypertension
- Obesity
Interventions
- BEHAVIORAL
-
Weight Reducing Diet
Behavioral intervention
- BEHAVIORAL
-
Exercise
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.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
University of Tennessee
lead OTHER
Principal Investigators
-
Robert C. Klesges, PhD · University of Tennessee Center for Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2011-05-31
- Completion
- 2011-06-30
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