Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064961
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2003-07-16
Brief Title:
Obesity Prevention After Smoking Cessation in Menopause
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 300 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None