SmokingOKRCTNCT01162577
Oklahoma Weight Concerns Quitline: a Randomized Cessation Trial
A study testing Weight Concerns in people with Smoking, run by Consumer Wellness Solutions at 1 site in United States.
Trial summary
The purpose of the "Weigh2Quit" study was to test in a randomized trial, a "weight concerns" intervention designed to reduce weight concerns that might impact cessation, increase physical activity and adherence to tobacco treatment, increase confidence in quitting, improve tobacco quit rates and decrease weight gain… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Weight Concerns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals were eligible for the study if they were age 18 or older, smoked at least 5 cigarettes per day, were willing to quit within 30 days from enrollment in the Helpline, were not pregnant or nursing, agreed to be in the study and randomized, agreed to the follow-up interview, provided a workable phone number with a secondary back-up number, had a BMI of at least 23 and reported having significant concerns about gaining weight with quitting.
Who cannot join
- Individuals were not eligible for the study if they had a BMI lower than 23 or were pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the "Weigh2Quit" study was to test in a randomized trial, a "weight concerns" intervention designed to reduce weight concerns that might impact cessation, increase physical activity and adherence to tobacco treatment, increase confidence in quitting, improve tobacco quit rates and decrease weight gain post-quit.
Read the detailed description
Smoking and obesity are the two biggest contributors to preventable morbidity and mortality. They are usually thought of independently, but for many people are inter-related. Cessation-related weight gain and concerns about weight gain are common and negatively impact cessation efforts.
Between March 2008 and November 2008 smokers who called the OKHL were screened for the presence of weight concerns and asked if they would be interested in a study offering the chance to speak with a weight coach (WC). Interested individuals were transferred to a specially trained Quit Coach (QC) who provided informed verbal consent, collected additional baseline data, obtained a second verbal consent to be randomized and were then randomized using a pre-programmed automated randomization procedure. Groups were randomly assigned in blocks of 20 so that after every 20th person randomized, the cells would be balanced. Individuals were randomized into either the control group to receive the standard quitline only (the OKHL 5-call program), or into the intervention group to receive standard care with integrated weight content plus three calls with a weight coach. All participants were offered a total of five tobacco cessations calls, access to Web Coach, tailored emails with quitting tips, access to the inbound support line, mailed quit guides, and nicotine replacement therapy (NRT) for cessation as appropriate. For the intervention group, QCs and WCs integrated weight concerns topics and components of the tobacco treatments into their calls with the primary goal of smoking cessation. A 6-month follow-up survey was conducted by the Oklahoma Tobacco Research Center, University of Oklahoma Health Sciences Center to compare outcomes between intervention and control conditions. The primary outcome was the 30-day quit rate. Secondary outcomes were:
90 day abstinence, adherence to tobacco treatment, confidence in quitting or staying quit, confidence in controlling weight gain after quitting, change in physical activity, participant satisfaction, change in weight concerns, change in weight by quit outcomes
We hypothesized that relative to controls, the 'Weight2Quit' intervention would:
- increase cessation without excessive weight gain
- increase satisfaction with the OKHL
- increase call completion rate
- reduce weight concerns, and
- increase confidence in quitting without weight gain THE STANDARD QUITLINE CESSATION PROGRAM The 5 proactive calls provided to participants in the multiple call programs are scheduled by mutual agreement between each participant and his or her Quit Coach. The aim is to set a quit date within 15 days, schedule calls around that quit date, and complete all calls within three months of enrollment.
THE WEIGH2QUIT INTERVENTION The intervention was modeled on evidence-based methods to address maladaptive weight gain concerns that negatively impact quitting (Perkins, 2001). In this study, we adapted the original intensive, in-person group intervention described by Perkins for delivery via a telephone-based quitline. Participants randomized to the Weigh2Quit intervention were offered the standard OKHL cessation program (with integrated weight concerns content) plus 3 additional calls with a weight coach and specialized support materials. The mailed materials included a description of the rationale of the new program, educational information and worksheets (e.g. self-monitoring forms for tracking maladaptive thoughts about weight and body image and tracking alternative thoughts). Intervention counseling calls were designed to increase smoking cessation and
- Conditions
- Smoking
- Being tested
- Weight Concerns
- Keywords
- Weight, Smoking, Quitline
- Medical subject headings
- Smoking, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight ConcernsBehavioural
Also called Standard Quitline
Standard Quitline plus weight coaching
| Study group | Role | What they receive |
|---|---|---|
| Intervetion | Experimental | The intervention group received the 5 standard tobacco calls plus 3 weight calls with a weight coach to address weight concerns related to quitting smoking Receives: Behavioral: Weight Concerns |
| Control | No intervention | Participants in this arm received only the 5 standard tobacco calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day abstinence
No smoking in the past 30 days
Measured: 6 months
Secondary outcomes (1)
Change in weight
Change in weight (pounds)between baseline and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oklahoma Tobacco Settlement Endowment Trust (TSET)
- Investigators
- Terry Bush, PhD, Principal investigator, Free & Clear, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162577
- Sponsor's protocol ID
- 0001
- Acronym
- OKRCT
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bush T, Levine MD, Deprey M, Cerutti B, Zbikowski SM, McAfee T, Mahoney L, Beebe L. Prevalence of Weight Concerns and Obesity Among Smokers Calling a Quitline. J Smok Cessat. 2008 Dec 1;4(5):74-78. doi: 10.1375/jsc.4.2.74.
PubMed 20548969Bush T, Levine MD, Beebe LA, Cerutti B, Deprey M, McAfee T, Boeckman L, Zbikowski S. Addressing weight gain in smoking cessation treatment: a randomized controlled trial. Am J Health Promot. 2012 Nov-Dec;27(2):94-102. doi: 10.4278/ajhp.110603-QUAN-238.
PubMed 23113779
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oklahoma Weight Concerns Quitline: a Randomized Cessation Trial
- ClinicalTrials.gov ID
- NCT01162577
- Acronym / sponsor ID
- OKRCT / 0001
- Conditions
- Smoking
- Keywords
- Weight, Smoking, Quitline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Oklahoma Tobacco Settlement Endowment Trust (TSET)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Jul 2010 (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 the "Weigh2Quit" study was to test in a randomized trial, a "weight concerns" intervention designed to reduce weight concerns that might impact cessation, increase physical activity and adherence to tobacco treatment, increase confidence in quitting, improve tobacco quit rates and decrease weight gain post-quit.
Detailed description
Smoking and obesity are the two biggest contributors to preventable morbidity and mortality. They are usually thought of independently, but for many people are inter-related. Cessation-related weight gain and concerns about weight gain are common and negatively impact cessation efforts.
Between March 2008 and November 2008 smokers who called the OKHL were screened for the presence of weight concerns and asked if they would be interested in a study offering the chance to speak with a weight coach (WC). Interested individuals were transferred to a specially trained Quit Coach (QC) who provided informed verbal consent, collected additional baseline data, obtained a second verbal consent to be randomized and were then randomized using a pre-programmed automated randomization procedure. Groups were randomly assigned in blocks of 20 so that after every 20th person randomized, the cells would be balanced. Individuals were randomized into either the control group to receive the standard quitline only (the OKHL 5-call program), or into the intervention group to receive standard care with integrated weight content plus three calls with a weight coach. All participants were offered a total of five tobacco cessations calls, access to Web Coach, tailored emails with quitting tips, access to the inbound support line, mailed quit guides, and nicotine replacement therapy (NRT) for cessation as appropriate. For the intervention group, QCs and WCs integrated weight concerns topics and components of the tobacco treatments into their calls with the primary goal of smoking cessation. A 6-month follow-up survey was conducted by the Oklahoma Tobacco Research Center, University of Oklahoma Health Sciences Center to compare outcomes between intervention and control conditions. The primary outcome was the 30-day quit rate. Secondary outcomes were:
90 day abstinence, adherence to tobacco treatment, confidence in quitting or staying quit, confidence in controlling weight gain after quitting, change in physical activity, participant satisfaction, change in weight concerns, change in weight by quit outcomes
We hypothesized that relative to controls, the 'Weight2Quit' intervention would:
- increase cessation without excessive weight gain
- increase satisfaction with the OKHL
- increase call completion rate
- reduce weight concerns, and
- increase confidence in quitting without weight gain THE STANDARD QUITLINE CESSATION PROGRAM The 5 proactive calls provided to participants in the multiple call programs are scheduled by mutual agreement between each participant and his or her Quit Coach. The aim is to set a quit date within 15 days, schedule calls around that quit date, and complete all calls within three months of enrollment.
THE WEIGH2QUIT INTERVENTION The intervention was modeled on evidence-based methods to address maladaptive weight gain concerns that negatively impact quitting (Perkins, 2001). In this study, we adapted the original intensive, in-person group intervention described by Perkins for delivery via a telephone-based quitline. Participants randomized to the Weigh2Quit intervention were offered the standard OKHL cessation program (with integrated weight concerns content) plus 3 additional calls with a weight coach and specialized support materials. The mailed materials included a description of the rationale of the new program, educational information and worksheets (e.g. self-monitoring forms for tracking maladaptive thoughts about weight and body image and tracking alternative thoughts). Intervention counseling calls were designed to increase smoking cessation and
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervetion | Experimental | Behavioral: Weight ConcernsThe intervention group received the 5 standard tobacco calls plus 3 weight calls with a weight coach to address weight concerns related to quitting smoking |
| Control | No intervention | –Participants in this arm received only the 5 standard tobacco calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals were eligible for the study if they were age 18 or older, smoked at least 5 cigarettes per day, were willing to quit within 30 days from enrollment in the Helpline, were not pregnant or nursing, agreed to be in the study and randomized, agreed to the follow-up interview, provided a workable phone number with a secondary back-up number, had a BMI of at least 23 and reported having significant concerns about gaining weight with quitting.
Key exclusion criteria (1 listed)
- Individuals were not eligible for the study if they had a BMI lower than 23 or were pregnant
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 |
|---|---|---|
| Weight ConcernsAlso: Standard QuitlineStandard Quitline plus weight coaching | Behavioural | Intervetion |
Primary outcome
30 day abstinence
Time frame: 6 months
No smoking in the past 30 days
1 secondary outcome
Change in weight
Time frame: 6 months
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 14 Jul 2010.
- Results publication: PubMed 20548969Bush T, Levine MD, Deprey M, Cerutti B, Zbikowski SM, McAfee T, Mahoney L, Beebe L. Prevalence of Weight Concerns and Obesity Among Smokers Calling a Quitline. J Smok Cessat. 2008 Dec 1;4(5):74-78. doi: 10.1375/jsc.4.2.74.
- Derived from this study: PubMed 23113779Bush T, Levine MD, Beebe LA, Cerutti B, Deprey M, McAfee T, Boeckman L, Zbikowski S. Addressing weight gain in smoking cessation treatment: a randomized controlled trial. Am J Health Promot. 2012 Nov-Dec;27(2):94-102. doi: 10.4278/ajhp.110603-QUAN-238.
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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.
Terry Bush, PhD principal investigator
Free & Clear, Inc.
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 Concerns in people with Smoking, run by Consumer Wellness Solutions 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 1 inclusion and 1 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 14 Jul 2010. 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.
What does the primary outcome measure?
30 day abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162577, which also lists 2 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 14 Jul 2010.