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Sponsored by: |
National Institute on Aging (NIA) |
Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00064961 |
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 |
MedlinePlus related topics: | Menopause Obesity Smoking Smoking Cessation |
Study Type: | Interventional |
Study Design: | Prevention, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 100 |
Study Start Date: | March 2000 |
Estimated Study Completion Date: | February 2006 |
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.
Ages Eligible for Study: | 45 Years to 59 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria
Study ID Numbers: | AG0004 |
First Received: | July 16, 2003 |
Last Updated: | February 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00064961 |
Health Authority: | United States: Federal Government |
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