ObesityNCT00064961
Obesity Prevention After Smoking Cessation in Menopause
A study testing Weight-management and smoking cessation maintenance and Smoking Cessation program in people with Obesity and Menopause, run by National Institute on Aging (NIA) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 59 years, women onlyHealthy volunteers can take part
- What is being tested?
- Weight-management and smoking cessation maintenance and Smoking Cessation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Being tested
- Individualized dietary-control and exercise program, Weight-management and smoking cessation maintenance, Smoking Cessation program
- Keywords
- Smoking Cessation
- Medical subject headings
- Obesity, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized dietary-control and exercise programBehavioural
Weight-management and smoking cessation maintenanceBehavioural
Smoking Cessation programBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2003 (estimated)
- Study startMar 2000
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064961
- Sponsor's protocol ID
- AG0004
- Status last verified
- Dec 2009
- First submitted
- 16 Jul 2003
- Last updated
- 11 Dec 2009
- Results posted
- No
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. doi: 10.2105/ajph.82.9.1238.
PubMed 1503165Williamson 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. doi: 10.1056/NEJM199103143241106.
PubMed 1997840Hall 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. doi: 10.2105/ajph.82.6.799.
PubMed 1585959Heymsfield 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. doi: 10.1016/0531-5565(94)90018-3.
PubMed 7925757Geiselman 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. doi: 10.1016/s0031-9384(97)00542-8.
PubMed 9618017
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Prevention After Smoking Cessation in Menopause
- ClinicalTrials.gov ID
- NCT00064961
- Acronym / sponsor ID
- AG0004
- Keywords
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2000
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 17 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized dietary-control and exercise program | Behavioural | – |
| Weight-management and smoking cessation maintenance | Behavioural | – |
| Smoking Cessation program | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 1503165Pirie 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. doi: 10.2105/ajph.82.9.1238.
- Background: PubMed 1997840Williamson 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. doi: 10.1056/NEJM199103143241106.
- Background: PubMed 1585959Hall 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. doi: 10.2105/ajph.82.6.799.
- Background: PubMed 7925757Heymsfield 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. doi: 10.1016/0531-5565(94)90018-3.
- Background: PubMed 9618017Geiselman 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. doi: 10.1016/s0031-9384(97)00542-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-management and smoking cessation maintenance and Smoking Cessation program in people with Obesity and Menopause, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00064961, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.