Promoting Smoking Cessation and Reducing Weight Gain

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00113711
First received: June 9, 2005
Last updated: June 23, 2005
Last verified: June 2005
  Purpose

To test whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Behavioral: smoking cessation
Behavioral: reducing diet

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: January 1995
Estimated Study Completion Date: August 1999
Detailed Description:

BACKGROUND:

When the study began in 1995, more females were initiating cigarette smoking, and a growing proportion cited fear of gaining weight as a major reason for refusing to even attempt quitting smoking. It had not yet been possible, however, to prevent post- cessation weight gain through dieting or behavioral treatment without undermining abstinence from smoking. The investigators proposed that prior interventions had been unsuccessful because: (a) their weight management interventions were too complex; (b) the programs thwarted a need of the patient in nicotine withdrawal to eat hedonically appealing, high-carbohydrate snacks; and (c) the programs heightened patients' emphasis on weight control at the expense of their emphasis on smoking cessation by asking them to initiate weight control before or simultaneously with quitting smoking.

DESIGN NARRATIVE:

The investigators collected pilot data on a promising 16-week intervention that they called the LATE WEIGHT PLAN because it emphasized smoking cessation for the first half of treatment and integrated weight management for the last half. The weight management module included a pre-packaged meal plan; high-carbohydrate, low-fat snacks; and low-intensity aerobic exercise. All patients continued in the weight management phase of treatment, regardless of whether they had succeeded in quitting smoking or were preparing to make new quit attempts. Based on pilot findings, the investigators estimated the point prevalence of smoking cessation for the LATE WEIGHT PLAN group to be 74% at the end of treatment, with weight gain less than 5 lb. An EARLY WEIGHT PLAN group controlled for the timing of the intervention, using the same target quit smoking date and 16 week program but integrating the weight management module into the first 8 weeks of treatment. Like others, they found that EARLY weight management efforts, while they may have prevented weight gain, apparently did so at some cost to smoking cessation, which they estimated to be 42% at 4 months. Finally, a CESSATION ONLY group controlled for the presence of a weight management intervention, by dealing exclusively with smoking cessation for the entire 16 week program. The CESSATION ONLY group had attained the worst outcome in terms of weight control and an intermediate outcome in terms of abstinence at the end of treatment (50%). By randomizing 315 female smokers to the three treatments and comparing abstinence and weight gain after 4 months of treatment and 6 month follow-up (10 months), they tested whether a behavioral intervention could indeed achieve the dual goals of promoting smoking cessation and minimizing weight gain.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

A total of 315 female smokers.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113711

Sponsors and Collaborators
Investigators
Investigator: Bonnie Spring University of Illinois at Chicago
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00113711     History of Changes
Other Study ID Numbers: 184
Study First Received: June 9, 2005
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on April 21, 2014