SmokingPhase 3NCT00040287
Theory-Based Interventions for Smoking and Obesity (Challenge) Trial
A Phase 3 study testing smoking cessation program in people with Smoking and Obesity, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- smoking cessation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,778 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to not given
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Division of Epidemiology, School of Public Health, Epidemiology Clinic Research Center, Suite 201, 1100 Washington Avenue South
Minneapolis, Minnesota, 55415
About this study
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.
Read the 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.
- Being tested
- smoking cessation program, weight control program
- Keywords
- smoking, obesity, weight loss, smoking cessation, weight control
- Medical subject headings
- Smoking, Obesity, Weight Loss, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation programBehavioural
weight control programBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2002 (estimated)
- Study startJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 1,778 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert Jeffery, Ph.D., Principal investigator, University of Minnesota, Division of Epidemiology, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040287
- Sponsor's protocol ID
- R01NS038441
- Status last verified
- May 2007
- First submitted
- 24 Jun 2002
- Last updated
- 17 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory-Based Interventions for Smoking and Obesity (Challenge) Trial
- ClinicalTrials.gov ID
- NCT00040287
- Acronym / sponsor ID
- R01NS038441
- Keywords
- smoking, obesity, weight loss, smoking cessation, weight control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,778 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 1999
- First posted
- 25 Jun 2002 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| smoking cessation program | Behavioural | – |
| weight control 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 17 May 2007.
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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.
Robert Jeffery, Ph.D. principal investigator
University of Minnesota, Division of Epidemiology, School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing smoking cessation program in people with Smoking and Obesity, run by National Institute of Neurological Disorders and Stroke (NINDS) 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?
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 17 May 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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 17 May 2007.