NCT00064961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2000

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 11, 2009

Status Verified

December 1, 2009

Enrollment Period

5.9 years

First QC Date

July 16, 2003

Last Update Submit

December 9, 2009

Conditions

ObesityMenopause

Keywords

Smoking Cessation

Interventions

Individualized dietary-control and exercise programBEHAVIORAL
Weight-management and smoking cessation maintenanceBEHAVIORAL
Smoking Cessation programBEHAVIORAL

Eligibility Criteria

Age45 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (5)

  • 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.

    PMID: 1503165BACKGROUND

  • 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. doi: 10.1056/NEJM199103143241106.

    PMID: 1997840BACKGROUND

  • 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. doi: 10.2105/ajph.82.6.799.

    PMID: 1585959BACKGROUND

  • 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. doi: 10.1016/0531-5565(94)90018-3.

    PMID: 7925757BACKGROUND

  • 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. doi: 10.1016/s0031-9384(97)00542-8.

    PMID: 9618017BACKGROUND

MeSH Terms

Conditions

ObesitySmoking Cessation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 16, 2003

First Posted

July 17, 2003

Study Start

March 1, 2000

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

December 11, 2009

Record last verified: 2009-12

Locations

US(1)