Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Cigarette Smoking
• Intervention / Treatment: Behavioral: Smoking cessation; Behavioral: Weight gain prevention and smoking cessation

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 Type: Interventional
• Enrollment (Actual): 2540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Alere Wellbeing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• Pregnant or Planning Pregnancy within 3 months
• Diabetic
• Previous weight loss surgery or planning weight loss surgery in next 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Behavioral: Smoking cessation	Behavioral: Smoking cessation; The control group will receive cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls.; Other Names: Tobacco cessation quitline
Experimental: Simultaneous; Behavioral: Weight gain prevention and smoking cessation	Behavioral: Weight gain prevention and smoking cessation; 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.; Other Names: Tobacco cessation quitline; Weight management treatment
Experimental: Sequential; Behavioral: Weight gain prevention and smoking cessation	Behavioral: Weight gain prevention and smoking cessation; 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.; Other Names: Tobacco cessation quitline; Weight management treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight	6 months
30-day point prevalence tobacco abstinence	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Consumer Wellness Solutions
• Collaborators: Northwestern University; SRI International
• Investigators: Principal Investigator: Terry Bush, PHD, Consumer Wellness Solutions

Publications and helpful links

General Publications

• Hartmann-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.
• Javitz 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.
• Bush 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.
• Bush 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 30, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Tobacco cessation; Weight gain prevention
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 1R01DA031147 (U.S. NIH Grant/Contract)