Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines

Obesity Clinical Trial

Official title:

Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867983
• Other study ID #: 1R01DA031147
• Status: Completed
• Phase: N/A
• First received: May 30, 2013
• Last updated: April 14, 2016
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Alere Wellbeing
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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. The interventions to be compared are cessation treatment alone versus cessation treatment combined with weight control treatment added either simultaneously or sequentially.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2540
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Obesity
• Overweight

Intervention

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.
• Smoking cessation
The control group will receive cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls.

Locations

Country	Name	City	State
United States	Alere Wellbeing	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Alere Wellbeing	Northwestern University, SRI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day point prevalence tobacco abstinence		6 months	No
Primary	Change in weight		6 months	No
Secondary	Other abstinence effectiveness (7-day, continuous abstinence, reduction in amount)		6 and 12 months	No
Secondary	Cost-effectiveness (cost per quit)		6 and 12 months	No
Secondary	Weight control cost-effectiveness (cost per pound not gained)		6 and 12 months	No