Cardiovascular DiseasesNCT00113074
Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers
A study testing Nicotine Replacement Therapy and Diet in people with Cardiovascular Diseases and Heart Diseases, run by Mark Vander Weg at 2 sites in United States.
Trial summary
The purpose of this study is to develop effective interventions that assist individuals with high blood pressure to quit smoking and prevent weight gain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Nicotine Replacement Therapy and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Smoke at least 5 cigarettes/day (or have quit within the last 6 weeks to enter the study for the weight gain prevention and BP control interventions)
- Pre-hypertensive or Stage I hypertension (systolic BP from 120 to 159 and/or diastolic BP from 80 to 99 mm Hg). Antihypertensive medications are not criteria for exclusion provided that BP is not over 160/100 mm Hg)
- Access to a telephone
Who cannot join
- History of unstable cardiovascular disease, including myocardial infarction, stroke, and unstable angina within three months of study start
- Coronary artery bypass grafting or angioplasty/stent within three months of study start
- Cardiac dysrhythmia treated with anti-arrhythmia medication, except stable atrial fibrillation
- Untreated hyperthyroidism or pheochromocytoma
- History of congestive heart failure (NYHA Class III or IV)
- ECG evidence of 2nd or 3rd degree atrioventricular block
Show all 20Show fewer
- Uncontrolled or Stage II Hypertension as defined as BP consistently above 160/100 mm Hg
- History of severe liver or kidney failure
- Current substance abuse (includes alcohol use in excess of 21 drinks a week)
- Presence of an unstable psychiatric condition
- Severe chronic obstructive pulmonary disease
- Symptomatic peripheral vascular disease
- Pulmonary hypertension with shortness of breath
- Congenital or valvular heart disease with shortness of breath
- Current use of a medication that may interfere with primary study endpoints or that may increase the risk of side effects from study medication that cannot be discontinued
- Pregnant or plans to become pregnant within the next year
- Planning to move out of the area or travel extensively during the intervention
- Any medical condition that would preclude any additional changes in diet
- Unable to further modify physical activity routine
- Cannot engage in moderate intensity exercise (e.g., walking)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa, Carver College of Medicine, Department of Internal Medicine, Division of General Internal Medicine
Iowa City, Iowa
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
About this study
Official title: Blood Pressure Control in Hypertensive Smokers
The purpose of this study is to develop effective interventions that assist individuals with high blood pressure to quit smoking and prevent weight gain.
Read the detailed description
BACKGROUND:
High blood pressure (BP), or hypertension, is a major risk factor for cardiovascular morbidity and mortality. Hypertension is associated with an elevated risk for several cardiovascular complications, including coronary heart disease, peripheral vascular disease, congestive heart failure, and stroke, as well as an increased risk for renal disease. Although there have been significant advances in the detection and treatment of high BP, approximately one in four adults in the United States is hypertensive. Cigarette smoking accounts for more than 400,000 premature deaths each year in this country alone, making it the leading cause of morbidity and mortality. Evidence from several epidemiological studies has demonstrated that, at any level of BP, smoking substantially increases the risk for all cardiovascular complications associated with hypertension. While cigarette smoking and hypertension both increase the risk of cardiovascular disease, these two risk factors act synergistically to produce a greater risk than their combined independent effects. Despite the considerable health risks, smoking among people with hypertension is very common, with a prevalence approaching that observed among those with normal BP. Unfortunately, although quitting smoking is especially important for patients with high BP, smoking cessation produces a nontrivial weight gain, averaging 5 kg, which may exacerbate hypertension in many patients with the disorder. Several studies have documented significant elevations in BP following smoking cessation, as well as increases in the prevalence of hypertension after quitting smoking. As such, it is important to develop effective interventions that assist in quitting smoking and preventing weight gain.
DESIGN NARRATIVE:
The objective of the trial is to recruit 750 smokers with Stage 1 hypertension or prehypertension (based on JNC VII criteria). The trial will provide all participants with a brief, validated, combined behavioral and pharmacologic smoking cessation intervention. Additionally, the study will randomly assign participants who are abstinent from smoking upon completing the cessation intervention to either a 12-week weight management and BP control program or self-help materials targeting lifestyle modification. The primary endpoint is change in BP among quit smokers at a one-year follow-up. Secondary endpoints include changes in body weight, dietary intake, urinary sodium excretion, physical activity, and relapse to smoking. Exploratory endpoints include changes in hypertensive status (e.g., movement from prehypertensive to hypertensive by JNC VII criteria) and changes in BP medication status. This is a multi-site clinical trial, with study locations in Rochester, Minnesota, and Iowa City, IA. The Rochester, MN site is currently closed for recruitment.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Being tested
- Nicotine Replacement Therapy, Diet
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyDrug
Nicotine replacement therapy program
DietBehavioural
Diet program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Weight management and blood pressure control intervention Receives: Drug: Nicotine Replacement Therapy; Behavioral: Diet |
| 3 | Active comparator | Self-help materials targeting lifestyle modification Receives: Drug: Nicotine Replacement Therapy; Behavioral: Diet |
| 2 | Experimental | Weight management intervention Receives: Drug: Nicotine Replacement Therapy; Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking
Change in systolic blood pressure in mmHg
Measured: Measured at Year 1
Change in Diastolic Blood Pressure at One Year Among People Who Have Quit Smoking
Change in diastolic blood pressure in mmHg
Measured: Measured at Year 1
Secondary outcomes (6)
Changes in Body Weight
Change in body weight in pounds from randomization to 12 months.
Measured: Measured at Year 1
Dietary Intake - Fruit and Vegetable Consumption
Change in self-reported daily fruit and vegetable consumption from randomization to 12 months. Fruit and vegetable consumption was measured by self-report using a dietary screener, which provides results in the form of number of servings per day.
Measured: Measured at Year 1
Urinary Sodium Chloride Excretion
Percent change in urinary sodium chloride (NaCL) from randomization to one-year
Measured: Measured at Year 1
Physical Activity: Leisure Time Physical Activity in METs
Change in leisure time physical activity in metabolic equivalents (METs) from randomization to one-year. METs reflect the ratio of working metabolic rate relative to resting metabolic rate, and are expressed as the energy expended per unit of time. For this study, METs were measured based on self-reported physical activity using the International Physical Activity Questionnaire (IPAQ) and are reported in the form of MET minutes.
Measured: Measured at Year 1
Relapse to Smoking
Number of participants who self-reported tobacco use during the last seven-days.
Measured: Measured at Year 1
Dietary Intake - Dietary Fat Consumption
Change in daily dietary fat consumption from randomization to 12 months.
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2005 (estimated)
- Study startSep 2004
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Vander Weg
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Mark Vander Weg, University of Iowa
- Investigators
- Mark W. Vander Weg, PhD, Principal investigator, University of Iowa, Carver College of Medicine, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113074
- Sponsor's protocol ID
- 200611724
- Other IDs
- R01HL072782
- Status last verified
- Mar 2024
- First submitted
- 3 Jun 2005
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vander Weg MW, Klesges RC, Ebbert JO, Lichty EJ, DeBon M, North F, Schroeder DR, Dubbert PM. Trial design: blood pressure control and weight gain prevention in prehypertensive and hypertensive smokers: the treatment and prevention study. Contemp Clin Trials. 2008 Mar;29(2):281-92. doi: 10.1016/j.cct.2007.07.003. Epub 2007 Jul 19.
PubMed 17716953
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control in Hypertensive Smokers
- ClinicalTrials.gov ID
- NCT00113074
- Acronym / sponsor ID
- 200611724
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Mark Vander WegUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Jun 2005 (estimated)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop effective interventions that assist individuals with high blood pressure to quit smoking and prevent weight gain.
Detailed description
BACKGROUND:
High blood pressure (BP), or hypertension, is a major risk factor for cardiovascular morbidity and mortality. Hypertension is associated with an elevated risk for several cardiovascular complications, including coronary heart disease, peripheral vascular disease, congestive heart failure, and stroke, as well as an increased risk for renal disease. Although there have been significant advances in the detection and treatment of high BP, approximately one in four adults in the United States is hypertensive. Cigarette smoking accounts for more than 400,000 premature deaths each year in this country alone, making it the leading cause of morbidity and mortality. Evidence from several epidemiological studies has demonstrated that, at any level of BP, smoking substantially increases the risk for all cardiovascular complications associated with hypertension. While cigarette smoking and hypertension both increase the risk of cardiovascular disease, these two risk factors act synergistically to produce a greater risk than their combined independent effects. Despite the considerable health risks, smoking among people with hypertension is very common, with a prevalence approaching that observed among those with normal BP. Unfortunately, although quitting smoking is especially important for patients with high BP, smoking cessation produces a nontrivial weight gain, averaging 5 kg, which may exacerbate hypertension in many patients with the disorder. Several studies have documented significant elevations in BP following smoking cessation, as well as increases in the prevalence of hypertension after quitting smoking. As such, it is important to develop effective interventions that assist in quitting smoking and preventing weight gain.
DESIGN NARRATIVE:
The objective of the trial is to recruit 750 smokers with Stage 1 hypertension or prehypertension (based on JNC VII criteria). The trial will provide all participants with a brief, validated, combined behavioral and pharmacologic smoking cessation intervention. Additionally, the study will randomly assign participants who are abstinent from smoking upon completing the cessation intervention to either a 12-week weight management and BP control program or self-help materials targeting lifestyle modification. The primary endpoint is change in BP among quit smokers at a one-year follow-up. Secondary endpoints include changes in body weight, dietary intake, urinary sodium excretion, physical activity, and relapse to smoking. Exploratory endpoints include changes in hypertensive status (e.g., movement from prehypertensive to hypertensive by JNC VII criteria) and changes in BP medication status. This is a multi-site clinical trial, with study locations in Rochester, Minnesota, and Iowa City, IA. The Rochester, MN site is currently closed for recruitment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: DietWeight management and blood pressure control intervention |
| 3 | Active comparator | Drug: Nicotine Replacement Therapy, Behavioral: DietSelf-help materials targeting lifestyle modification |
| 2 | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: DietWeight management intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Smoke at least 5 cigarettes/day (or have quit within the last 6 weeks to enter the study for the weight gain prevention and BP control interventions)
- Pre-hypertensive or Stage I hypertension (systolic BP from 120 to 159 and/or diastolic BP from 80 to 99 mm Hg). Antihypertensive medications are not criteria for exclusion provided that BP is not over 160/100 mm Hg)
- Access to a telephone
Key exclusion criteria (20 listed)
- History of unstable cardiovascular disease, including myocardial infarction, stroke, and unstable angina within three months of study start
- Coronary artery bypass grafting or angioplasty/stent within three months of study start
- Cardiac dysrhythmia treated with anti-arrhythmia medication, except stable atrial fibrillation
- Untreated hyperthyroidism or pheochromocytoma
- History of congestive heart failure (NYHA Class III or IV)
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 |
|---|---|---|
| Nicotine Replacement TherapyNicotine replacement therapy program | Drug | 1, 2, 3 |
| DietDiet program | Behavioural | 1, 2, 3 |
Primary outcome
Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking
Time frame: Measured at Year 1
Change in systolic blood pressure in mmHg
Change in Diastolic Blood Pressure at One Year Among People Who Have Quit Smoking
Time frame: Measured at Year 1
Change in diastolic blood pressure in mmHg
6 secondary outcomes
Changes in Body Weight
Time frame: Measured at Year 1
Dietary Intake - Fruit and Vegetable Consumption
Time frame: Measured at Year 1
Urinary Sodium Chloride Excretion
Time frame: Measured at Year 1
Physical Activity: Leisure Time Physical Activity in METs
Time frame: Measured at Year 1
Relapse to Smoking
Time frame: Measured at Year 1
Dietary Intake - Dietary Fat Consumption
Time frame: Measured at Year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17716953Vander Weg MW, Klesges RC, Ebbert JO, Lichty EJ, DeBon M, North F, Schroeder DR, Dubbert PM. Trial design: blood pressure control and weight gain prevention in prehypertensive and hypertensive smokers: the treatment and prevention study. Contemp Clin Trials. 2008 Mar;29(2):281-92. doi: 10.1016/j.cct.2007.07.003. Epub 2007 Jul 19.
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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.
Mark W. Vander Weg, PhD principal investigator
University of Iowa, Carver College of Medicine, Department of Internal Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Replacement Therapy and Diet in people with Cardiovascular Diseases and Heart Diseases, run by Mark Vander Weg at 2 sites in United States.
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 3 inclusion and 20 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking (time frame: Measured at Year 1). 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?
On the ClinicalTrials.gov record for NCT00113074, which also lists 1 linked publication.
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 29 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.