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

NCT00113074 | Completed Results DMC

• 2 other identifiers: 200611724R01HL072782
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking

  Change in systolic blood pressure in mmHg

  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 at Year 1

Secondary Outcomes (6)

• Changes in Body Weight

  Measured at Year 1

• Dietary Intake - Fruit and Vegetable Consumption

  Measured at Year 1

• Urinary Sodium Chloride Excretion

  Measured at Year 1

• Physical Activity: Leisure Time Physical Activity in METs

  Measured at Year 1

• Relapse to Smoking

  Measured at Year 1

Study Arms (3)

1

EXPERIMENTAL

Weight management and blood pressure control intervention

Drug: Nicotine Replacement Therapy; Behavioral: Diet

3

ACTIVE COMPARATOR

Self-help materials targeting lifestyle modification

Drug: Nicotine Replacement Therapy; Behavioral: Diet

2

EXPERIMENTAL

Weight management intervention

Drug: Nicotine Replacement Therapy; Behavioral: Diet

Interventions

Nicotine Replacement Therapy DRUG

Nicotine replacement therapy program

1; 2; 3

Diet BEHAVIORAL

Diet program

1; 2; 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Access to a telephone

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Vander Weg: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Iowa, Carver College of Medicine, Department of Internal Medicine, Division of General Internal Medicine

Iowa City, Iowa, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 17716953 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension

Interventions

Nicotine Replacement Therapy; Diet

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Mark Vander Weg
• Organization: University of Iowa

mark-vanderweg@uiowa.edu

319-338-0581

Study Officials

• Mark W. Vander Weg, PhD

  University of Iowa, Carver College of Medicine, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mark W. Vander Weg, PhD, University of Iowa

Study Record Dates

• First Submitted: June 3, 2005
• First Posted: June 6, 2005
• Study Start: September 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-03

Locations

US (2)