Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

While smoking cessation leads to significant improvements in mortality and morbidity, weight
gain post-cessation partially attenuates this benefit. Furthermore, concerns about
postcessation weight gain are common and are often cited as a reason to delay cessation
attempts. In addition, postcessation weight gain is associated with smoking relapse. Thus,
although the health benefits of smoking cessation outweigh the negative impact of weight
gain, ideally there would be intervention "packages" that would not require that people
choose between smoking cessation and nontrivial weight gain. Thus, in the proposed study, the
investigators will determine whether two very promising methods of reducing postcessation
weight gain, namely a weight stability intervention (based on the evidence-based Small
Changes intervention) versus a weight loss intervention (based on the evidence-based Look
AHEAD intensive lifestyle intervention) followed by a smoking cessation intervention are
efficacious for reducing postcessation weight gain. The investigators will randomize 400
smokers to one of three arms: a) a weight stability intervention prior to cessation (Group
1); b) a weight loss intervention prior to cessation (Group 2), or c) a self-guided
intervention prior to cessation (Group 3) and to determine the efficacy of the interventions
on preventing weight gain at 12 month follow-up. All three conditions receive a highly
efficacious in-person smoking cessation behavioral intervention and six months of Varenicline
(ChantixTM) pharmacotherapy. Those participants randomized to the Group 1 and Group 2
conditions will receive monthly booster weight management sessions, after completing the
behavioral smoking cessation intervention. The primary outcomes will be weight change and
smoking cessation at 12 month follow-up. In addition, the investigators will gather process
data on mediators of treatment outcome via measures of treatment engagement (e.g., session
attendance, varenicline utilization). The investigators will be able to determine whether a
weight stability intervention or a weight loss intervention is efficacious in reducing
post-cessation weight gain. The intervention results, if successful, could be disseminated
and make a significant contribution towards curtailing obesity in this vulnerable population.

Inclusion Criteria:

- Participants must wish to quit smoking in the next 30 days

- Have smoked 5 or more cigarettes a day for at least 1 year

- Participants must be 18 years or older as the safety and efficacy of varenicline
therapy has not been established for pediatric patients

- Participants must have a BMI of 22 kg/m2 or greater, as it would not be recommended to
have those who are underweight or the lower end of the normal BMI range attempt a 5%
weight loss (if assigned to the Group 2 condition)

- Participants must have access to a telephone and daily access to email, if using a
cell phone, participants must be willing to use their cell phone minutes for weekly
phone interventions

- Participants must have the ability to understand consent process in English

- If female and of childbearing age, participant must have a negative pregnancy test and
must agree to use contraception during participation in the study

- All participants must be willing to be randomized to the study conditions and wait
eight weeks prior to beginning smoking cessation (during which they will participate
in the weight management intervention to which they are assigned).

- Participants must live within 45 minutes of the data collection sites

- Participants must be able to exercise for at least 10 minutes

- Participants must have BP < 140/90 and a heart rate of >40 beats per minute and <120
beats per minute.

Exclusion Criteria:

- Participants must not have a known contraindication, allergy or hypersensitivity to
varenicline therapy

- Participants must not currently (in the previous 30 days) be participating in other
behavioral or pharmacologic weight or smoking cessation interventions

- Participants must not have had weight loss surgery (hx of gastric bypass, stomach
stapling or banding)

- Participants must not have lost > or equal to10 lbs in the past 6 months

- Participants must not be taking a medication that impacts weight

- Participants must not have used an investigational drug within the last 30 days

- Participants must not have self-reported current depression based upon the Center for
Epidemiologic Studies-Depression score (CESD-R; > or equal to a score of 16)

- Participants must not have current suicidal thoughts or have a lifetime history of a
suicide attempt as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS)

- Participants must not self-report a history of psychosis, bipolar disorder, or
anorexia nervosa

- Participants must not have self-reported current alcohol abuse or illicit substance
use

- Participants must not have kidney disease; have unstable cardiovascular conditions
(e.g., unstable angina, myocardial infarction within the past 3 months, cardiac
dysrhythmia other than medication-controlled atrial fibrillation or paroxysmal
supraventricular tachycardia, or medically uncontrolled or untreated hypertension) or
HIV

- Participants must not have another member of their household already participating in
this study

- Participants must not be currently pregnant or lactating or planning to become
pregnant in the next 12 months, or have been pregnant within the last 6 months

- Participants must not be planning to move from the area in the next year.

- Weight limit of 385 pounds