Obesity Prevention After Smoking Cessation in Menopause - Tabular View

Tracking Information
First Received Date ^ICMJE	July 16, 2003
Last Updated Date	December 9, 2009
Start Date ^ICMJE	March 2000
Primary Completion Date	February 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00064961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Obesity Prevention After Smoking Cessation in Menopause
Official Title ^ICMJE
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 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.
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Condition ^ICMJE	Obesity Menopause
Intervention ^ICMJE	Behavioral: Individualized dietary-control and exercise program Behavioral: Weight-management and smoking cessation maintenance Behavioral: Smoking Cessation program
Study Arms / Comparison Groups
Publications *	Pirie PL, McBride CM, Hellerstedt W, Jeffery RW, Hatsukami D, Allen S, Lando H. Smoking cessation in women concerned about weight. Am J Public Health. 1992 Sep;82(9):1238-43. Williamson DF, Madans J, Anda RF, Kleinman JC, Giovino GA, Byers T. Smoking cessation and severity of weight gain in a national cohort. N Engl J Med. 1991 Mar 14;324(11):739-45. Hall SM, Tunstall CD, Vila KL, Duffy J. Weight gain prevention and smoking cessation: cautionary findings. Am J Public Health. 1992 Jun;82(6):799-803. Heymsfield SB, Gallagher D, Poehlman ET, Wolper C, Nonas K, Nelson D, Wang ZM. Menopausal changes in body composition and energy expenditure. Exp Gerontol. 1994 May-Aug;29(3-4):377-89. Review. Geiselman PJ, Anderson AM, Dowdy ML, West DB, Redmann SM, Smith SR. Reliability and validity of a macronutrient self-selection paradigm and a food preference questionnaire. Physiol Behav. 1998 Mar;63(5):919-28.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	February 2006
Primary Completion Date	February 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	45 Years to 59 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00064961
Responsible Party
Study ID Numbers ^ICMJE	AG0004
Study Sponsor ^ICMJE	National Institute on Aging (NIA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Aging (NIA)
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP