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Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines

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ClinicalTrials.gov Identifier: NCT01867983
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 15, 2016
Sponsor:
Collaborators:
SRI International
Northwestern University
Information provided by (Responsible Party):
Alere Wellbeing

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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Overweight Obesity Behavioral: Weight gain prevention and smoking cessation Behavioral: Smoking cessation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 30-day point prevalence tobacco abstinence [ Time Frame: 6 months ]
  2. Change in weight [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Other abstinence effectiveness (7-day, continuous abstinence, reduction in amount) [ Time Frame: 6 and 12 months ]
  2. Cost-effectiveness (cost per quit) [ Time Frame: 6 and 12 months ]
  3. Weight control cost-effectiveness (cost per pound not gained) [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867983


Locations
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United States, Washington
Alere Wellbeing
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Alere Wellbeing
SRI International
Northwestern University
Investigators
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Principal Investigator: Terry Bush, PHD Alere Wellbeing
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alere Wellbeing
ClinicalTrials.gov Identifier: NCT01867983    
Other Study ID Numbers: 1R01DA031147 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Alere Wellbeing:
Tobacco cessation
Weight gain prevention
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms