Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers

Blood Pressure Control in Hypertensive Smokers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113074

Enrollment

139

Registered

2005-06-06

Start date

2004-09-30

Completion date

2011-06-30

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Hypertension

Brief 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.

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.

Interventions

DRUGNicotine Replacement Therapy

Nicotine replacement therapy program

BEHAVIORALDiet

Diet program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

Measure	Time frame	Description
Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking	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	Measured at Year 1	Change in diastolic blood pressure in mmHg

Secondary

Measure	Time frame	Description
Urinary Sodium Chloride Excretion	Measured at Year 1	Percent change in urinary sodium chloride (NaCL) from randomization to one-year
Physical Activity: Leisure Time Physical Activity in METs	Measured at Year 1	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.
Changes in Body Weight	Measured at Year 1	Change in body weight in pounds from randomization to 12 months.
Dietary Intake - Dietary Fat Consumption	Measured at Year 1	Change in daily dietary fat consumption from randomization to 12 months.
Relapse to Smoking	Measured at Year 1	Number of participants who self-reported tobacco use during the last seven-days.
Dietary Intake - Fruit and Vegetable Consumption	Measured at Year 1	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
1 - Weight Management and Blood Pressure Control Intervention Weight management and blood pressure control intervention Nicotine Replacement Therapy: Nicotine replacement therapy program Diet: Diet program	49
3 - Self-help Materials Targeting Lifestyle Modification Self-help materials targeting lifestyle modification Nicotine Replacement Therapy: Nicotine replacement therapy program Diet: Diet program	43
2 - Weight Management Intervention Weight management intervention Nicotine Replacement Therapy: Nicotine replacement therapy program Diet: Diet program	47
Total	139

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	10	10	14

Baseline characteristics

Characteristic	1 - Weight Management and Blood Pressure Control Intervention	3 - Self-help Materials Targeting Lifestyle Modification	2 - Weight Management Intervention	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	4 Participants	5 Participants	5 Participants	14 Participants
Age, Categorical Between 18 and 65 years	45 Participants	38 Participants	41 Participants	124 Participants
Age, Continuous	46.0 years STANDARD_DEVIATION 13.8	46.6 years STANDARD_DEVIATION 13.1	47.3 years STANDARD_DEVIATION 14.2	46.6 years STANDARD_DEVIATION 13.6
Body Mass Index	30.6 kg/m^2 STANDARD_DEVIATION 7.6	29.5 kg/m^2 STANDARD_DEVIATION 6.2	30.0 kg/m^2 STANDARD_DEVIATION 6.1	30.1 kg/m^2 STANDARD_DEVIATION 6.6
Diastolic Blood Pressure	79.3 mmHg STANDARD_DEVIATION 8.4	79.1 mmHg STANDARD_DEVIATION 8.7	77.9 mmHg STANDARD_DEVIATION 9.5	78.8 mmHg STANDARD_DEVIATION 8.8
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	0 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants	41 Participants	46 Participants	134 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	3 Participants	0 Participants	6 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	44 Participants	39 Participants	45 Participants	128 Participants
Region of Enrollment United States	49 participants	43 participants	47 participants	139 participants
Sex: Female, Male Female	19 Participants	13 Participants	18 Participants	50 Participants
Sex: Female, Male Male	30 Participants	30 Participants	28 Participants	88 Participants
Systolic Blood Pressure	130.3 mmHg STANDARD_DEVIATION 11.3	131.6 mmHg STANDARD_DEVIATION 11.5	128.8 mmHg STANDARD_DEVIATION 12.2	130.2 mmHg STANDARD_DEVIATION 11.6

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 49	0 / 43	0 / 47
other Total, other adverse events	24 / 49	19 / 43	24 / 47
serious Total, serious adverse events	0 / 49	1 / 43	1 / 47