NCT00119821

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 2, 2015

Status Verified

July 1, 2011

Enrollment Period

6.7 years

First QC Date

July 6, 2005

Last Update Submit

November 30, 2015

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionObesity

Outcome Measures

Primary Outcomes (2)

  • Smoking cessation rates

    Measured at 1 year

  • Body weight changes

    Measured at 1 year

Secondary Outcomes (5)

  • Changes in dietary intake

    Measured at 1 year

  • Changes in physical activity

    Measured at 1 year

  • Changes in blood pressure and hypertensive status

    Measured at 1 year

  • Changes in blood pressure medication status

    Measured at 1 year

  • Changes in salt intake

    Measured at 1 year

Study Arms (3)

I

EXPERIMENTAL

Behavioral Weight Reduction

Behavioral: Weight Reducing Diet

II

OTHER

Exercise

Behavioral: Exercise

III

OTHER

Smoking Cessation

Behavioral: Smoking Cessation

Interventions

Weight Reducing DietBEHAVIORAL

Behavioral intervention

I
ExerciseBEHAVIORAL

Moderate exercise implemented plus behavioral intervention.

II
Smoking CessationBEHAVIORAL

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.

III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionObesity

Interventions

Diet, ReducingExercise

Condition Hierarchy (Ancestors)

Vascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert C. Klesges, PhD

    University of Tennessee Center for Health Sciences

    STUDY CHAIR

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

December 2, 2015

Record last verified: 2011-07