Comparative Effectiveness of Adding Weight Control to Smoking Cessation Quitlines

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.

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