Obesity Prevention After Smoking Cessation in Menopause
|ClinicalTrials.gov Identifier: NCT00064961|
Recruitment Status : Completed
First Posted : July 17, 2003
Last Update Posted : December 11, 2009
|Condition or disease||Intervention/treatment|
|Obesity Menopause||Behavioral: Individualized dietary-control and exercise program Behavioral: Weight-management and smoking cessation maintenance Behavioral: Smoking Cessation program|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||March 2000|
|Primary Completion Date :||February 2006|
|Study Completion Date :||February 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064961
|United States, Louisiana|
|LSU Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|