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OpenTrials
Completed

NCT Number: NCT00064961

Obesity Prevention After Smoking Cessation in Menopause

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.

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Key information

Age range

45 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

LSU Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized dietary-control and exercise program

Behavioral

Weight-management and smoking cessation maintenance

Behavioral

smoking cessation program

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Jul 17, 2003
Registry last updated
Dec 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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