Obesity Prevention After Smoking Cessation in Menopause

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00064961
First received: July 16, 2003
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

This study addresses the high risk of weight gain associated with smoking cessation in women. The obesity prevention pilot study is designed for the primary prevention of weight gain that can lead to overweight in normal-weight women, that can progress to obesity in women who are already overweight, and for the prevention of additional weight gain in obese women with BMI greater than or equal to 30.0. Fat and other macronutrient intake, specifically, sugar, complex carbohydrates, and protein, are analyzed as a target for individually tailored, weight control intervention following smoking cessation in Caucasian and African American women.


Condition Intervention
Obesity
Menopause
Behavioral: Individualized dietary-control and exercise program
Behavioral: Weight-management and smoking cessation maintenance
Behavioral: Smoking Cessation program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 100
Study Start Date: March 2000
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Middle-aged women, especially African Americans, who quit smoking are at high risk for weight gain, overweight, and obesity. Postcessation weight gain has been attributed to increased food intake, which in turn, has been ascribed to a selective increase in high-sugar and other high-carbohydrate foods with a high-fat content. This study compares the relative effectiveness, for postmenopausal Caucasian and African American women, of following an empirically validated smoking cessation program with either 1) a group cessation maintenance program with standard exercise advice and food pyramid instructions for healthy eating or 2) an individually tailored, dietary-control, exercise, weight-management and cessation-maintenance program. Effectiveness is assessed by weight change from baseline to postcessation months 6, 12, and 20.

The second aim is to assess overall fat and other specific macronutrient intake (sugar, complex carbohydrates, and protein) and total caloric intake with the use of a novel macronutrient self-selection paradigm in Caucasian and African-American postmenopausal women at baseline prior to smoking cessation, after being abstinent for one week, and again at 6, 12, and 20 months postcessation.

The third aim is to assess whether there is differential responsiveness on the above measures in postmenopausal Caucasian vs. African-American women.

  Eligibility

Ages Eligible for Study:   45 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female aged 45 - 59 at time of enrollment
  • African-American or Caucasian; able to confirm racial heritage of past two generations in family
  • Postmenopausal
  • Smokers (more than 10 cigarettes per day for 1 year or more)
  • Written physician approval to participate in program and medical clearance that use of over-the-counter nicotine replacement is not contraindicated based on patient's medical status

Exclusion Criteria

  • Men
  • Age below 45 or above 59
  • Nonsmokers
  • Currently in a standardized weight-reduction program or taking medications for weight loss
  • History or presence of significant psychiatric illness (e.g., eating disorders, psychosis, psychoactive substance abuse, major depression)
  • History of presence of severe physical illness (e.g., renal failure, hepatic failure, cancer, immunological disease)
  • Unable to complete long-term study commitment, including anticipating moving out of study area prior to completion of the study
  • Unable to confirm racial heritage of past two generations in family.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064961

Locations
United States, Louisiana
LSU Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators