An interventional study of Individualized dietary-control and exercise program and Weight-management and smoking cessation maintenance in Obesity and Menopause, sponsored by National Institute on Aging (NIA). Completed at 1 site in United States. Open to female participants aged 45 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-11.
Sponsored by National Institute on Aging (NIA) · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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National Institute on Aging (NIA)