Cigarette SmokingNCT01867983
Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines
A study testing Weight gain prevention and smoking cessation and Smoking cessation in people with Cigarette Smoking and Overweight, run by Consumer Wellness Solutions at 1 site in United States.
Trial summary
This randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Overweight, Obesity
- What is being tested?
- Weight gain prevention and smoking cessation and Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,540 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2016
- 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
- Participating Client
- Not Re-Enrolling
- USA Resident
- Wants to quit in the next 30 days
- Use Cigarettes (other types ok, but must use cigarettes)
- 18 years or older
Show all 12Show fewer
- Speak English
- Provide Phone
- Provide Email Address
- Use 10 cigarettes per day or more
- BMI of 18.5 or above
- No history of anorexia or bulimia
Who cannot join
- Pregnant or Planning Pregnancy within 3 months
- Diabetic
- Previous weight loss surgery or planning weight loss surgery in next 12 months
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially.
Read the detailed description
Cigarette smoking and obesity are the leading causes of preventable morbidity and mortality in the U.S. Quitting smoking can lead to weight gain and obesity-related co-morbidities. Quitlines provide a natural population-based laboratory to test innovative approaches to help people quit smoking and control their weight. However, there is a lack of understanding of the effectiveness of intervening on both smoking and weight at the same time. Thus, we propose to test the impact on abstinence and weight control of adding an evidence-based weight control intervention simultaneously with or sequentially (following) cessation treatment via telephone quitlines.
This study, modeled on Co-I Dr. Bonnie Springs successful efficacy trial, is the first attempt to replicate the findings using widely available phone and web-based programs. The cessation program will be the effective and cost effective Quit For Life® quitline operated by Alere Wellbeing. The weight management program will be the Weight Talk program operated by Alere Wellbeing, also shown to be feasible, acceptable and effective in producing positive changes in weight, eating behaviors and physical activity. We will be using 5 calls from the Weight Talk program for the intervention content for the simultaneous and sequential arms.
The proposed randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially. We propose to recruit 2550 smokers who call a quitline and randomly assign them to one of three groups: (a) Standard Care (STD): cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls); (b) Simultaneous: weight control treatment simultaneous with cessation treatment (5 proactive calls with a quit coach combined with weight coach/nutritionist followed by 5 'contact control calls'), or (c) Sequential: weight control treatment added after cessation treatment (5 proactive calls with a quit coach followed by 5 weight coach/nutritionist calls). All three interventions include a total of 10 phone counseling calls, interactive web, mailed support materials, access to nicotine replacement therapy (NRT) and unlimited participant-initiated calls.
Significance: This study is novel. Combining two phone/web based behavior change programs together has never been tested. A cost-effective, population-based strategy for delivering a combined smoking cessation and weight control intervention stands to make a significant impact. The option of new telephone counseling that helps smokers quit and control their weight could encourage smokers to call quitlines who otherwise might not because they are concerned about gaining weight. Combined smoking and weight treatment could also increase abstinence rates over current best-practice treatment and do so without weight gained its adverse consequences. Moreover, if effective, the intervention could rapidly be disseminated to the 500,000 smokers who use quitlines annually in the U.S., a large proportion of whom are obese.
- Conditions
- Cigarette Smoking, Overweight, Obesity
- Being tested
- Weight gain prevention and smoking cessation, Smoking cessation
- Keywords
- Tobacco cessation, Weight gain prevention
- Medical subject headings
- Cigarette Smoking, Overweight, Obesity, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight gain prevention and smoking cessationBehavioural
Also called Tobacco cessation quitline, Weight management treatment
The two intervention groups will receive weight gain prevention either:
Simultaneous: weight control treatment simultaneous with cessation treatment (5 proactive calls with a quit coach combined with weight coach/nutritionist followed by 5 'contact control calls'), or Sequential: weight control treatment added after cessation treatment (5 proactive calls with a quit coach followed by 5 weight coach/nutritionist calls). All three study arms will include a total of 10 phone counseling calls, interactive web, mailed support materials, access to nicotine replacement therapy (NRT) and unlimited participant initiated calls.
Smoking cessationBehavioural
Also called Tobacco cessation quitline
The control group will receive cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Behavioral: Smoking cessation Receives: Behavioral: Smoking cessation |
| Simultaneous | Experimental | Behavioral: Weight gain prevention and smoking cessation Receives: Behavioral: Weight gain prevention and smoking cessation |
| Sequential | Experimental | Behavioral: Weight gain prevention and smoking cessation Receives: Behavioral: Weight gain prevention and smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day point prevalence tobacco abstinence
Measured: 6 months
Change in weight
Measured: 6 months
Secondary outcomes (3)
Other abstinence effectiveness (7-day, continuous abstinence, reduction in amount)
Measured: 6 and 12 months
Cost-effectiveness (cost per quit)
Measured: 6 and 12 months
Weight control cost-effectiveness (cost per pound not gained)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
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 Cigarette 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SRI International, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Terry Bush, PHD, Principal investigator, Consumer Wellness Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867983
- Sponsor's protocol ID
- 1R01DA031147
- Status last verified
- Apr 2016
- First submitted
- 30 May 2013
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902Javitz HS, Bush TM, Lovejoy JC, Torres AJ, Wetzel T, Wassum KP, Tan MM, Alshurafa N, Spring B. Six Month Abstinence Heterogeneity in the Best Quit Study. Ann Behav Med. 2019 Nov 9;53(12):1032-1044. doi: 10.1093/abm/kaz014.
PubMed 31009528Bush T, Lovejoy J, Javitz H, Torres AJ, Wassum K, Tan MM, Spring B. Simultaneous vs. sequential treatment for smoking and weight management in tobacco quitlines: 6 and 12 month outcomes from a randomized trial. BMC Public Health. 2018 May 31;18(1):678. doi: 10.1186/s12889-018-5574-7.
PubMed 29855294Bush T, Lovejoy J, Javitz H, Magnusson B, Torres AJ, Mahuna S, Benedict C, Wassum K, Spring B. Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial. BMC Public Health. 2016 Jul 22;16:615. doi: 10.1186/s12889-016-3231-6.
PubMed 27443485
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines
- ClinicalTrials.gov ID
- NCT01867983
- Acronym / sponsor ID
- 1R01DA031147
- Conditions
- Cigarette Smoking, Overweight, Obesity
- Keywords
- Tobacco cessation, Weight gain prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,540 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- SRI International, Northwestern University
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Jun 2013 (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 randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially.
Detailed description
Cigarette smoking and obesity are the leading causes of preventable morbidity and mortality in the U.S. Quitting smoking can lead to weight gain and obesity-related co-morbidities. Quitlines provide a natural population-based laboratory to test innovative approaches to help people quit smoking and control their weight. However, there is a lack of understanding of the effectiveness of intervening on both smoking and weight at the same time. Thus, we propose to test the impact on abstinence and weight control of adding an evidence-based weight control intervention simultaneously with or sequentially (following) cessation treatment via telephone quitlines.
This study, modeled on Co-I Dr. Bonnie Springs successful efficacy trial, is the first attempt to replicate the findings using widely available phone and web-based programs. The cessation program will be the effective and cost effective Quit For Life® quitline operated by Alere Wellbeing. The weight management program will be the Weight Talk program operated by Alere Wellbeing, also shown to be feasible, acceptable and effective in producing positive changes in weight, eating behaviors and physical activity. We will be using 5 calls from the Weight Talk program for the intervention content for the simultaneous and sequential arms.
The proposed randomized controlled trial compares the effectiveness for both smoking cessation and weight control of two alternative combined interventions offered via telephone quitline, as compared to standard of care quitline treatment addressing cessation alone. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially. We propose to recruit 2550 smokers who call a quitline and randomly assign them to one of three groups: (a) Standard Care (STD): cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls); (b) Simultaneous: weight control treatment simultaneous with cessation treatment (5 proactive calls with a quit coach combined with weight coach/nutritionist followed by 5 'contact control calls'), or (c) Sequential: weight control treatment added after cessation treatment (5 proactive calls with a quit coach followed by 5 weight coach/nutritionist calls). All three interventions include a total of 10 phone counseling calls, interactive web, mailed support materials, access to nicotine replacement therapy (NRT) and unlimited participant-initiated calls.
Significance: This study is novel. Combining two phone/web based behavior change programs together has never been tested. A cost-effective, population-based strategy for delivering a combined smoking cessation and weight control intervention stands to make a significant impact. The option of new telephone counseling that helps smokers quit and control their weight could encourage smokers to call quitlines who otherwise might not because they are concerned about gaining weight. Combined smoking and weight treatment could also increase abstinence rates over current best-practice treatment and do so without weight gained its adverse consequences. Moreover, if effective, the intervention could rapidly be disseminated to the 500,000 smokers who use quitlines annually in the U.S., a large proportion of whom are obese.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Smoking cessationBehavioral: Smoking cessation |
| Simultaneous | Experimental | Behavioral: Weight gain prevention and smoking cessationBehavioral: Weight gain prevention and smoking cessation |
| Sequential | Experimental | Behavioral: Weight gain prevention and smoking cessationBehavioral: Weight gain prevention and smoking cessation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participating Client
- Not Re-Enrolling
- USA Resident
- Wants to quit in the next 30 days
- Use Cigarettes (other types ok, but must use cigarettes)
Key exclusion criteria (3 listed)
- Pregnant or Planning Pregnancy within 3 months
- Diabetic
- Previous weight loss surgery or planning weight loss surgery in next 12 months
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 gain prevention and smoking cessationAlso: Tobacco cessation quitline, Weight management treatmentThe two intervention groups will receive weight gain prevention either: Simultaneous: weight control treatment simultaneous with cessation treatment (5 proactive calls with a quit coach combined with weight coach/nutritionist followed by 5 'contact control calls'), or Sequential: weight control treatment added after cessation treatment (5 proactive calls with a quit coach followed by 5 weight coach/nutritionist calls). All three study arms will include a total of 10 phone counseling calls, interactive web, mailed support materials, access to nicotine replacement therapy (NRT) and unlimited participant initiated calls. | Behavioural | Sequential, Simultaneous |
| Smoking cessationAlso: Tobacco cessation quitlineThe control group will receive cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls. | Behavioural | Control |
Primary outcome
30-day point prevalence tobacco abstinence
Time frame: 6 months
Change in weight
Time frame: 6 months
3 secondary outcomes
Other abstinence effectiveness (7-day, continuous abstinence, reduction in amount)
Time frame: 6 and 12 months
Cost-effectiveness (cost per quit)
Time frame: 6 and 12 months
Weight control cost-effectiveness (cost per pound not gained)
Time frame: 6 and 12 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 15 Apr 2016.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Derived from this study: PubMed 31009528Javitz HS, Bush TM, Lovejoy JC, Torres AJ, Wetzel T, Wassum KP, Tan MM, Alshurafa N, Spring B. Six Month Abstinence Heterogeneity in the Best Quit Study. Ann Behav Med. 2019 Nov 9;53(12):1032-1044. doi: 10.1093/abm/kaz014.
- Derived from this study: PubMed 29855294Bush T, Lovejoy J, Javitz H, Torres AJ, Wassum K, Tan MM, Spring B. Simultaneous vs. sequential treatment for smoking and weight management in tobacco quitlines: 6 and 12 month outcomes from a randomized trial. BMC Public Health. 2018 May 31;18(1):678. doi: 10.1186/s12889-018-5574-7.
- Derived from this study: PubMed 27443485Bush T, Lovejoy J, Javitz H, Magnusson B, Torres AJ, Mahuna S, Benedict C, Wassum K, Spring B. Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial. BMC Public Health. 2016 Jul 22;16:615. doi: 10.1186/s12889-016-3231-6.
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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
Consumer Wellness Solutions
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 gain prevention and smoking cessation and Smoking cessation in people with Cigarette Smoking and Overweight, 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 12 inclusion and 3 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 15 Apr 2016. 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 point prevalence tobacco abstinence (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01867983, 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 15 Apr 2016.