Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines
1 other identifier
interventional
2,540
1 country
1
Brief 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. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 15, 2016
April 1, 2016
2.6 years
May 30, 2013
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
30-day point prevalence tobacco abstinence
6 months
Change in weight
6 months
Secondary Outcomes (3)
Other abstinence effectiveness (7-day, continuous abstinence, reduction in amount)
6 and 12 months
Cost-effectiveness (cost per quit)
6 and 12 months
Weight control cost-effectiveness (cost per pound not gained)
6 and 12 months
Study Arms (3)
Control
ACTIVE COMPARATORBehavioral: Smoking cessation
Simultaneous
EXPERIMENTALBehavioral: Weight gain prevention and smoking cessation
Sequential
EXPERIMENTALBehavioral: Weight gain prevention and smoking cessation
Interventions
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.
The control group will receive cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls.
Eligibility Criteria
You may qualify if:
- Participating Client
- Not Re-Enrolling
- USA Resident
- Wants to quit in the next 30 days
- Use Cigarettes (other types ok, but must use cigarettes)
- years or older
- 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
You may not qualify if:
- Pregnant or Planning Pregnancy within 3 months
- Diabetic
- Previous weight loss surgery or planning weight loss surgery in next 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Consumer Wellness Solutionslead
- SRI Internationalcollaborator
- Northwestern Universitycollaborator
Study Sites (1)
Alere Wellbeing
Seattle, Washington, 98104, United States
Related Publications (5)
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.
PMID: 39868569DERIVEDHartmann-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.
PMID: 34611902DERIVEDJavitz 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.
PMID: 31009528DERIVEDBush 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.
PMID: 29855294DERIVEDBush 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.
PMID: 27443485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry Bush, PHD
Consumer Wellness Solutions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 4, 2013
Study Start
August 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04