Cardiovascular DiseasesNCT00119821
Strategies to Reduce Weight Gain in Hypertensive Smokers
A study testing Weight Reducing Diet, Exercise and Smoking Cessation in people with Cardiovascular Diseases and Heart Diseases, run by University of Tennessee.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Weight Reducing Diet, Exercise and Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoke cigarettes
- Hypertension or elevated blood pressure (a "high normal" designation by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC VI] criteria)
Who cannot join
- Inability to understand consent procedures
- History of an allergic reaction to nicotine replacement therapy
- History of atopic or eczematous dermatitis
- Chronic or severe dermatosis
- History of unstable heart disease, including heart attack, stroke, and unstable angina in the 6 months prior to study entry
- Coronary artery bypass grafting or angioplasty/stent in the 3 months prior to study entry
Show all 28Show fewer
- Cardiac dysrhythmia (except atrial fibrillation) treated with anti-arrhythmia medication
- History of congestive heart failure (NYHA Class III or IV)
- ECG evidence of 2nd or 3rd degree AV block
- Uncontrolled or stage II hypertension, defined as blood pressure typically greater than 160/100 mm Hg
- History of severe kidney or liver failure
- Current substance abuse (includes alcohol use in excess of 21 drinks a week)
- Severe COPD
- Insulin-dependent diabetes mellitus
- Fasting blood sugar greater than 160 mg/dl
- Hemoglobin less than 11 g/dl
- Untreated hyperthyroidism
- Severe peripheral vascular disease
- Pheochromocytoma
- Pulmonary hypertension
- Valvular heart disease
- Presence of an unstable psychiatric condition
- Current use of a medication that may interfere with study participation or that may increase the risk of side effects from study medication
- Pregnant or plan to become pregnant within the year following study entry
- Planning to move out of the area or travel extensively during the study
- Current medical condition that would preclude any additional changes in diet; dieters and individuals on a special diet will not be excluded from the study
- Unable to modify physical activity, or cannot engage in moderate intensity exercise (e.g., walking); participants who regularly engage in physical activity will not be excluded from the study
- No access to a telephone
About this study
Official title: Weight Gain Prevention in Hypertensive Smokers
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.
Read the detailed description
BACKGROUND:
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.
DESIGN NARRATIVE:
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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Being tested
- Weight Reducing Diet, Exercise, Smoking Cessation
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Reducing DietBehavioural
Behavioral intervention
ExerciseBehavioural
Moderate exercise implemented plus behavioral intervention.
Smoking CessationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Behavioral Weight Reduction Receives: Behavioral: Weight Reducing Diet |
| II | Other | Exercise Receives: Behavioral: Exercise |
| III | Other | Smoking Cessation Receives: Behavioral: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rates
Measured: Measured at 1 year
Body weight changes
Measured: Measured at 1 year
Secondary outcomes (5)
Changes in dietary intake
Measured: Measured at 1 year
Changes in physical activity
Measured: Measured at 1 year
Changes in blood pressure and hypertensive status
Measured: Measured at 1 year
Changes in blood pressure medication status
Measured: Measured at 1 year
Changes in salt intake
Measured: Measured at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startSep 2004
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert C. Klesges, University of Tennessee
- Investigators
- Robert C. Klesges, PhD, Study chair, University of Tennessee Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119821
- Sponsor's protocol ID
- 225
- Other IDs
- R01HL074845
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2005
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Gain Prevention in Hypertensive Smokers
- ClinicalTrials.gov ID
- NCT00119821
- Acronym / sponsor ID
- 225
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
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.
DESIGN NARRATIVE:
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Weight Reducing DietBehavioral Weight Reduction |
| II | Other | Behavioral: ExerciseExercise |
| III | Other | Behavioral: Smoking CessationSmoking Cessation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smoke cigarettes
- Hypertension or elevated blood pressure (a "high normal" designation by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC VI] criteria)
Key exclusion criteria (28 listed)
- Inability to understand consent procedures
- History of an allergic reaction to nicotine replacement therapy
- History of atopic or eczematous dermatitis
- Chronic or severe dermatosis
- History of unstable heart disease, including heart attack, stroke, and unstable angina in the 6 months prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Reducing DietBehavioral intervention | Behavioural | I |
| ExerciseModerate exercise implemented plus behavioral intervention. | Behavioural | II |
| Smoking CessationNicotine 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. | Behavioural | III |
Primary outcome
Smoking cessation rates
Time frame: Measured at 1 year
Body weight changes
Time frame: Measured at 1 year
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Klesges, PhD study chair
University of Tennessee Center for Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Weight Reducing Diet, Exercise and Smoking Cessation in people with Cardiovascular Diseases and Heart Diseases, run by University of Tennessee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rates (time frame: Measured at 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.