Promoting Smoking Cessation and Reducing Weight Gain

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00113711
Collaborator
(none)
55

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: smoking cessation
  • Behavioral: reducing diet
N/A

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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Prevention
Study Start Date :
Jan 1, 1995
Actual Study Completion Date :
Aug 1, 1999

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 100 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    A total of 315 female smokers.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • : Bonnie Spring, University of Illinois at Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00113711
    Other Study ID Numbers:
    • 184
    • R01HL052577
    First Posted:
    Jun 10, 2005
    Last Update Posted:
    May 13, 2016
    Last Verified:
    Jun 1, 2005
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2016