Theory-Based Interventions for Smoking and Obesity (Challenge) Trial - Full Text View

Purpose

The purpose of this study is to examine a new theory for understanding the processes that govern behavior change by observing how people’s beliefs and feelings about smoking cessation or weight loss change as they participate in smoking cessation or weight control programs. This study also seeks to improve the ability of treatment programs to help people maintain changes in their behavior.

Condition	Intervention	Phase
Smoking Obesity	Behavioral: smoking cessation program Behavioral: weight control program	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Smoking

U.S. FDA Resources

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):


Estimated Enrollment:	1778
Study Start Date:	January 1999

Detailed Description:

The goal of this clinical trial is to examine a new theory for understanding the processes that govern short-term versus long-term behavior change. The study will examine how people’s beliefs and feelings about smoking cessation or weight loss change as they participate in either a smoking cessation program or a weight control program. Also, the study will improve the ability of treatment programs to help people maintain changes in their behavior. The project involves a series of two parallel investigations.

Study 1 tests the hypothesis that intervention methods that influence cost/benefit expectations related to quitting smoking and losing weight will have different effects on long-term smoking cessation and weight loss. The participants are randomly selected to treatment programs that induce heightened or realistic outcome expectations.

Study 2 tests the hypothesis that intervention methods that influence perceived satisfaction with behavior change will have different effects on long-term smoking cessation and weight loss. The participants are randomly selected to treatment programs that induce them to evaluate the consequences of behavior change either in comparison to past or ideal outcomes.

All of the intervention programs used in these studies are based on highly effective treatment procedures. The programs differ in how information about weight loss and smoking cessation is presented, how the participants are encouraged to think about their achievements during the treatment programs, and how much help is given to the participants in organizing their thoughts during the programs.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Eligibility criteria for the smoking cessation studies were: between 18 and 60 years old, a minimum 2-year history of smoking, a current level of smoking > 10 cigarettes per day, and agreement to participate in the study.

Eligibility requirements for the weight loss studies were: between 18 and 60 years old, body mass index (weight/height2) > 27.0, 20 percent or more above desirable weight according to medical standards, and consent to participate.

Smokers and overweight persons were excluded if currently being treated by a physician for a serious physical or psychological disorder (e.g., heart disease, cancer, depression). Women were excluded if currently pregnant, pregnant in the last 6 months, or intending to become pregnant in the next 18 months. People who were overweight and who also smoked were considered eligible for participation in either weight loss or smoking cessation programs. However, they received treatment only for the particular behavior problem targeted by the study they chose to participate in.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040287

Locations


United States, Minnesota
University of Minnesota, Division of Epidemiology, School of Public Health, Epidemiology Clinic Research Center, Suite 201, 1100 Washington Avenue South
Minneapolis, Minnesota, United States, 55415

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators


Principal Investigator:	Robert Jeffery, Ph.D.	University of Minnesota, Division of Epidemiology, School of Public Health

More Information


ClinicalTrials.gov Identifier:	NCT00040287 History of Changes
Other Study ID Numbers:	R01NS038441 ( US NIH Grant/Contract Award Number )
Study First Received:	June 24, 2002
Last Updated:	May 16, 2007

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):


smoking obesity weight loss smoking cessation weight control

Additional relevant MeSH terms:


Obesity Overnutrition Nutrition Disorders	Overweight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on June 26, 2017