Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
Phase: NA
Conditions: Weight Change, Body, Smoking Cessation
Sponsor: University of Tennessee

Efficacy of Two Novel Behavioral Post-
cessation Weight Gain Interventions 
NCT03156660 
Document Uploaded 21APR2022 
Document Created 10NOV2020 
 
 

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1. Purpose
Although smoking cessation accrues significant health benefits, regardless of the duration of smoking 
(4, 25, 26), it is typically accompanied by weight gain. A recent meta-analysis quantified this weight gain 
as, on average, 1.1 kg, 2.3 kg, 2.9 kg, 4.2 kg, and 4.7 kg at 1, 2, 3, 6, and 12 months after quitting, 
respectively (9). Concerns about postcessation weight gain are common and are often cited as a reason 
to delay cessation attempts (10, 11); furthermore, postcessation weight gain is associated with smoking 
relapse (10-12).  
           While there is some ongoing debate (13-15) about the effectiveness of behavioral weight 
management programs in conjunction with smoking cessation programs, it appears that behavioral 
weight management programs have not been able to successfully reduce postcessation weight gain 
(16).  In addition, contrary to popular belief, there was no indication that involvement in weight 
management programs impacted abstinence (16, 17). Moreover, while some short-term weight gain 
attenuation has been observed with some pharmacotherapies (e.g., nicotine replacement therapy, 
varenicline), there is no long-term weight gain prevention benefit for any of the pharmacotherapies (27-
30).
           Much like weight maintenance after weight loss has proven to be challenging (18), weight 
maintenance after smoking cessation has been difficult to achieve. In a trial unrelated to postcessation 
weight gain, Wing and colleagues (19) hypothesized that making small, consistent changes may be 
beneficial for weight gain prevention. Wing et al. (19) tested this hypothesis in a recent study and found 
that participants who received their ‘Small Changes' intervention gained significantly less weight as 
compared to the control group. Given these positive results, this approach may be translated to 
interventions focusing on other individuals at high risk for weight gain (i.e., those who are about to 
undertake smoking cessation).
While a weight gain prevention intervention is one promising approach for managing 
postcessation weight gain, another viable option is induction of weight loss prior to smoking cessation to 
offset anticipated postcessation weight gain. To develop an intervention producing pre-cessation 
compensatory weight loss, it is logical to draw from the breadth of knowledge in adult weight 
management.  Many recent behavioral lifestyle interventions, such as the Look AHEAD Intensive 
Lifestyle Intervention (ILI), have successfully produced clinically significant long-term weight losses (20) 
and have demonstrated improved health outcomes (31). While promising, it is not yet clear whether 
lifestyle programs developed for weight loss can be effective in “counteracting” the weight gain 
associated with smoking cessation. Given that the ILI produced the largest long-term weight losses to 
date (20), translation of this intervention to postcessation weight management makes sense. Thus, in 
the proposed study, we will determine whether a weight gain prevention intervention and/or a weight 
loss intervention followed by a behavioral smoking cessation intervention (together with 6 months of 
varenicline pharmacotherapy) are efficacious for reducing postcessation weight gain.
2. Rationale
Previous research has shown that interventions have not been successful in significantly 
reducing postcessation weight gain (16). Our proposal is highly innovative in that we will evaluate two 
new and promising interventions for their ability to reduce postcessation weight gain at 12 month 
follow-up. The first intervention, the ‘Small Steps’ intervention, is not only a cutting edge study in the 
area of weight management (19), it is an innovative approach for postcessation weight management, 
where the goal is not weight loss but weight gain prevention (i.e., “weight stability”). Thus, the weight 
stability intervention will be the first novel approach for treating postcessation weight gain that we will 
test. Our second intervention is also innovative and tests whether long-term postcessation weight gain 
can be prevented by first initiating a weight loss prior to smoking cessation. To accomplish this weight 
loss, we will translate the most efficacious weight loss intervention to date, the Look AHEAD ILI (20). By 
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testing both of these interventions against a comparison group receiving the smoking cessation 
intervention with bibliotherapy support, we will move the field forward in identifying the most 
promising approaches to reducing postcessation weight gain.
Another novel feature of the proposed study is our target population. While previous studies 
have largely focused on women (16), we will have targeted recruitment of men, so that we recruit both 
men and women to this study, to facilitate the generalizability of our findings. In addition, men were 
found in previous research (32) to be more likely to relapse after weight gain. Furthermore, most 
previous studies of postcessation weight gain interventions failed to even report the race/ethnic 
composition of their sample (17), let alone focus on recruiting a diverse sample, as we plan to do. For 
these reasons, we expect our proposed interventions, if as effective as expected, will make a significant 
public health contribution to curtailing escalating obesity in this vulnerable population.
3. Study/ Project Population
In this study, we will determine whether two very promising methods of reducing postcessation 
weight gain, namely a weight stability intervention versus a weight loss intervention followed by a 
smoking cessation intervention, are efficacious for reducing postcessation weight gain. Given the 
negative health implications of weight gain after smoking cessation and the difficulty in reducing 
postcessation weight gain in previous interventions, we propose the following:
To randomize up to 400 smokers to 1 of 3 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 weight 
management prior to cessation (Group 3) and to determine the efficacy of the interventions on 
preventing weight gain at 12 month follow-up. All 3 conditions receive a highly efficacious behavioral 
smoking cessation program and 6 months of varenicline pharmacotherapy (ChantixTM), the most 
efficacious medication for smoking cessation (21, 22). Since smoking cessation and body weight are 
confounded, smoking cessation status and duration of cessation will be examined as covariates.
Inclusion Criteria:
-Participants must be 18 years or older
-Participants must wish to quit smoking in the next 30 days 
-Participants must have smoked 5 or more cigarettes a day for at least 1 year
-Participants must have a self-reported 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 Group 2)
-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 as well as for 
some or all of the remote data collection visits
- All women of childbearing age must have a negative pregnancy test and must agree to use 
contraception during participation in the study
- Participants must also 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 have blood pressure that is < 150/95 mmHg and heart rates of >40 beats per minute 
and <120 beats per minute (according to their health care provider)
-Participants must be able to exercise for at least 10 minutes
-Participants must also have the ability to understand the consent process in English
Exclusion Criteria:
-Have a known contraindication, allergy or hypersensitivity to Varenicline
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- Are currently (in the previous 30 days) participating in other behavioral or pharmacologic weight or 
smoking cessation interventions
- Have used an investigational drug within the last 30 days
- Have current suicidal thoughts or have a lifetime history of a suicide attempt as defined by the 
Columbia-Suicide Severity Rating Scale (C-SSRS) (76)
- Have a self-reported history of psychosis, bipolar disorder or anorexia nervosa
-Self-report current alcohol abuse or illicit substance use
- Have kidney disease or liver disease; HIV; have unstable cardiovascular conditions, or have history of 
cancer in the last 5 years
-Taking medications that impact weight (see list)
-History of gastric bypass, stomach stapling, banding or other weight loss surgery
-Lost > 10 pounds in the last 6 months
- Have another member of their household already participating in this study
-Pregnancy within the last 6 months, breastfeeding or planning to become pregnant during the study   
 follow-up time (12 months)
-Weight limit of 385 pounds
4. Research Design
As seen in Figure 1, we will randomize up to 400 participants to 3 conditions: a) a weight stability 
intervention (Group 1); b) a weight loss intervention (Group 2); and c) a minimal intervention condition 
(Group 3). All 3 conditions receive a highly efficacious smoking cessation program and 6 months of 
varenicline pharmacotherapy (ChantixTM). Those participants randomized to Group 1 & 2 will receive 
monthly booster weight management sessions, after completing the smoking cessation intervention. 
5. Study Project Procedures
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Intervention Trial Screening and Baseline Procedures. Individuals who meet the phone screening 
eligibility criteria will be invited to schedule a remote Screening Visit (via phone) and the participant’s e-
signature will be obtained via DocuSign. If the self-reporting questionnaires cannot be done via phone 
they may be emailed or mailed (along with an addressed and stamped envelope) to the participant for 
completion. If the participant does not want to use DocuSign, the consent form may be mailed to 
prospective participants with a return envelope and staff will conduct the consent process over the 
phone prior to the participant signing the consent form and mailing it back. If consent is done in this 
way, staff will wait to complete the rest of the remote Screening Visit until receiving the signed consent 
form. If appropriate, a pregnancy test will be mailed to the participant along with instructions and staff 
will obtain their self-reported pregnancy test result via a follow-up call. If the participant is willing, they 
may email a picture of their test result. Participants will receive information regarding how to complete 
3 behavioral run-in items, as an indicator of their motivation to participate in the trial over the next 12 
months. 
Behavioral run-in tasks include:
1.
A daily diet and exercise journal (3 days)
2.
Liking the study on Facebook (encouraged, but not required)
3.
Obtaining physician permission to participate
Participants will complete another remote study visit (“Baseline”) to evaluate behavioral run-in 
performance and determine randomization eligibility. A BodyTrace e-scale will be mailed to the 
participant and they will be asked to weigh to confirm eligibility. If participants meet eligibility 
requirements, they may begin the randomization process. 
The biostatistician will randomize the participants to one of the three study conditions. Participants 
(n=400) will be randomly assigned in a ratio of 2 (Group 1, n=160): 2 (Group 2, n=160): 1 (Group 3, 
n=80). However; when less than 40 participants are recruited for a wave, the biostatistician will more 
evenly distribute the participants. Participants will be asked to complete another remote study visit for 
their randomization assignment and to meet their interventionist. Prior to this visit, participants will be 
mailed their study materials. After this visit, participants will be asked to weigh again on the BodyTrace 
scale.
Weight Management Interventions. Participants will complete their randomly assigned weight 
management intervention before initiating the smoking cessation intervention.
Weight Stability Condition (Group 1). Participants will be asked to keep their weight stable during the 
initial 8 weeks of the study.
Intervention Components:
1) Participants will receive lesson materials adapted from the Small Changes intervention (19).
2) As frequent weighing is a key component to this and most weight management programs (82), 
participants will be encouraged to engage in daily weight self-monitoring on the BodyTraceTM e-scale 
(http://www.bodytrace.com/), which they will be given at randomization. Each time a participant 
weighs, the e-scale will upload the weight automatically to a secure database, so that timely tailored 
feedback on weighing frequency/progress can be provided by the interventionist through email.
3) Participants will be provided with Fit Bit activity trackers to self-monitor their steps, consistent with 
the Small Changes intervention.
4) If subjects are randomized to Group 1, they will receive via mail a small reward valued less than two 
dollars, each week during the weight and smoking cessation sessions, then monthly during the booster 
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sessions, if they maintain their baseline weight or maintain a weight that is less than 1.4 kilograms above 
their baseline weight. 
Weight Loss Condition (Group 2). Participants will be asked to achieve a weight loss goal of at least 5% 
of their baseline weight by week 8.
Intervention Components:
1) Participants will receive tailored calorie and fat goals based on their baseline weight (83).
2) Participants will be encouraged to engage in daily dietary intake and physical activity self-
monitoring using a website or app, as these electronic tools facilitate self-monitoring (84).
3) Like the participants in Group 2, participants will be given a BodyTraceTM e-scale at randomization 
and will be asked to weigh themselves daily. Each time a participant weighs, the e-scale will upload the 
weight automatically to a secure database, so that timely tailored feedback on weighing 
frequency/progress can be provided by the interventionist each week through email.
4) Lesson materials for each session with be drawn from the Look AHEAD ILI and will cover core 
concepts of weight management (e.g., self-monitoring, exercise, portion size estimation, stress 
management, stimulus control, goal setting, problem solving).
5) Meal replacements will be provided to participants for 8 weeks as a method to achieve the study’s 
calorie and fat goals and as a strategy to control portions. Participants will be encouraged to replace 2 
meals (typically breakfast and lunch) with a meal replacement and will be advised to consume a third 
meal of conventional foods as well as additional fruits and vegetables until they reach their daily caloric 
goals.
6) Participants will be provided with graded physical activity goals to reach the goal of at least 175 
minutes of moderate intensity exercise (e.g., brisk walking) per week (83), similar to physical activity 
goals set in a previous weight management trial with smokers (67), or 10,000 steps per day. Participants 
will be provided with Fit Bit activity trackers to self-monitor their steps, consistent with the Look AHEAD 
protocol (83)
Bibliotherapy Condition (Group 3). Participants randomized to Group 3 will wait for 8 weeks before 
initiating the same smoking cessation intervention as the other two conditions, while they review the 
provided weight management focused book.
Intervention Components:
1) At randomization, participants will receive the EatingWell Diet book, as a minimal intervention that 
will provide information regarding weight management.
2) Like the participants in the other conditions, participants will be given a BodyTraceTM e-scale at 
randomization and will be asked to weight themselves daily. However, they will not receive 
interventionist feedback about their weighing frequency or weight trajectory
Behavioral Smoking Cessation Intervention. Participants in all conditions will get our evidence-based in-
person 6 session group-based smoking cessation intervention (44, 45, 89). Participants will transition to 
the smoking cessation intervention at week 9; they will receive the smoking cessation intervention with 
the same group with whom they received the weight management intervention, in order to preserve 
group social support as well as reduce contamination concerns. First, we will prepare participants for the 
quitting process, including providing varenicline at the first session. We will guide them through setting 
a quit date, implementing smoking cessation “rituals” (e.g., getting rid of ashtrays), reducing the number 
of cigarettes per day, and what to expect when they quit (e.g., withdrawal symptoms). By anticipating 
these issues, participants are able to better cope with them when they do arise. The second phase is the 
actual quitting process and getting through the first several days of being a nonsmoker. Given that this is 
the most difficult phase for participants (and is when the most relapse occurs), we will schedule an 
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individual telephone call during this week for problem solving with the participant. Finally, we will 
discuss both short-term and long-term relapse prevention strategies in the third phase.
Pharmacologic Intervention. All participants will receive varenicline (i.e., ChantixTM) in conjunction with 
the behavioral smoking cessation intervention. All participants will receive varenicline 0.5 mg once daily 
for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg 
twice daily for a total of 6 months of treatment.
Booster Weight Management Sessions: Participants randomized to Group 1 and 2 will receive monthly 
booster weight management sessions, after completing the 6-week behavioral smoking cessation 
intervention. There will be 5 booster sessions (week 16, 20, 24, 28, and 32) that will focus on problem 
solving related to weight management. Participants will receive the booster sessions with the same 
group with whom they received the weight management and smoking cessation interventions, in order 
to preserve group social support as well as reduce contamination concerns. We decided to focus these 
booster sessions on problem solving for both Group 1 and 2.
Intervention Fidelity Monitoring. Our previous experience in weight management and smoking 
cessation research suggests that the following quality procedures will help ensure treatment fidelity: 1) 
detailed intervention protocol development; 2) careful interventionist training, certification, and 
periodic re-training; 3) randomly select 20% of intervention sessions to record and code to ensure 
protocol adherence and to provide corrective feedback; 4) documentation of all intervention contacts to 
monitor participant exposure to treatment; and 5) weekly study meetings to review overall adherence 
to structured protocols and prevent any drift between interventionists. These study meetings (attended 
by the supervising investigators and the behavioral interventionists) will also include problem solving 
related to challenging cases and refining skills.
Measurement.  Data collection visits will be scheduled at baseline, randomization, and at 2 month (after 
the weight management component), at 4 month (after completion of the smoking cessation 
intervention), at 8 month (after completion of the varenicline pharmacotherapy), and at 12 month 
follow-up. Follow-up measures will be obtained by trained staff who are blinded to treatment 
assignment (Table 1). Participants who complete the 4 month, 8 month and 12 month visits will receive 
a financial incentive. Participants will be asked to weigh themselves on their BodyTrace e-scale. If they 
report point prevalence abstinence, a cotinine test  will be mailed to the participant along with 
instructions for use and reporting of the results. For all visits, if completely phone-based visits are not 
possible, then the self-reporting questionnaires may be emailed or mailed (along with an addressed and 
stamped envelope) to the participants for completion and entered into the database by trained staff 
who are blinded to treatment assignment.
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Table 1. Study Phases and Measurement (X=for all participants; 0=for Group 1 & 2 participants)
Phone Screening
Screening
Baseline
Randomization
Follow-up Phase
W eek
-2
-1
0
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
16
20
24
28
32
52
Inclusion/Exclusion
X
Informed Consent
X
Demographics
X
Urine Pregnancy Test (self-reported 
result)
X
Smoking History
X
Why Do You Smoke
X
Self-Efficacy
X
Treatment Preference
X
Weight Concern
X
X
Return to Smoking
X
X
Importance of Weight and Smoking 
Cessation
X
X
Smoking Behaviors
X
X
X
X
X
Difficulty of Weight Program and 
Perceived Effectiveness
X
X
Difficulty of Smoking Cessation 
Program
X
X
X
Weight Efficacy Lifestyle 
X
X
X
X
X
Weight Management Behaviors
X
X
X
X
Perceived Stress
X
X
X
X
X
Healthy Days 
X
X
X
X
X
Physical Activity
X
X
X
X
X
Depression
X
X
X
X
X
X
X
X
X
Suicidality
X
X
X
X
X
X
X
X
X
Height (self-reported)
X
Bodytrace Weight
X*
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
Intervention Adherence
0
0
0
0
0
0
0
0
X
X
X
X
X
X
0
0
0
0
0
Varenicline Adherence
X
X
X
X
X
X
X
Salivary Cotinine
X
X
X
X
Program Satisfaction
X
X
X
X
Weight Management Phase
Smoking Cessation 
Intervention +Varenicline 
Phase
Weight Booster Sessions 
+ Varenicline Phase
*Self-reported weight rather than BodyTrace will be recorded at SV
Study Measures.
Demographics and Contact Information:  Participants will complete a questionnaire regarding their 
gender, age, marital status, race, ethnicity, education level, income, as well as provide contact 
information to facilitate high retention rates, which will be updated at each data collection visit.
Smoking History: We will assess the age at which participants first started smoking cigarettes regularly, 
whether they have smoked at least 100 cigarettes in their life, how many years they have been a regular 
smoker, number of cigarettes per day smoked in the past year, number of quit attempts, and the length 
of the most recent quit attempt. We will also assess the frequency of use of various nicotine and 
tobacco containing products over the past year.
Why Do You Smoke: We will utilize the “Why Do You Smoke?” questionnaires that was adapted for 
assessing smoking specific weight concern. The scale shows evidence of predictive validity. A score of 7 
or below indicates a low level of weight concern, whereas a score of 22 or greater indicates a high level 
of smoking specific weight concern. Participants will complete this 18-item measure by indicating their 
degree of agreement on a 6-point scale.
Self-Efficacy: We are assessing general self-efficacy with the Self-Performance Survey short form. These 
4 items are rated on a 5-point scale.
Treatment Preference: We are assessing participants’ preference for each of the treatment conditions at 
baseline to explore whether match or mismatch to treatment preference influenced outcome.
Weight Concern: We will measure participants weight concerns related to smoking. The 6 items on this 
scale are scored on a 10-point scale.
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Return to Smoking: The 11 item scale (63) will be used to assess the degree of weight loss that may 
precipitate a return to smoking. Participants are asked if they would return to smoking after a gain of 
less than 2 pounds, and each subsequent question adds 2 pounds until the participant is asked, "If after 
quitting smoking you gained 20 pounds or more, would you start smoking?” Those that indicate that 
they would return to smoking after any weight gain will be classified as “weight concerned.”
Importance of Weight and Smoking Cessation: The extent to which participants prioritized weight 
control and smoking cessation will be measured using 2 items rated on 10-point scales.
Smoking Behaviors: We will assess nicotine dependence with the Fagerström Test for Nicotine 
Dependence (100) and smoking status (both point prevalence and prolonged abstinence). For those 
participants who report point prevalence abstinence, we will test cotinine levels. Cotinine, a direct 
metabolite of nicotine, will be measured using the iScreen® OFD Cotinine test. iScreen is a valid and 
reliable method for verifying smoking status, with a specificity of >99%, a sensitivity of 97.6%. We will 
consider participants with at least 30 ng/mL cotinine in their saliva to be smokers; this liberal definition 
will avoid false positives due to secondhand smoke. 
Difficulty of Weight Program, Perceived Effectiveness, Difficulty of Smoking Cessation Program: We will 
measure program perception by having participants use 10-point scales to rate their expectations about 
the degree to which treatment would help them quit smoking, minimize weight gain, and be effective 
overall, similar to previous research. Participants will also rate how difficult each condition (Group 1, 2, 
or 3) will be to implement as well as the difficulty of the smoking cessation program. Participants will 
also be asked which approach they thought would be most effective. 
Weight Efficacy Lifestyle Scale: We will assess self-efficacy for restricting eating in 20 high-risk situations. 
The Weight Efficacy Lifestyle Scale has adequate internal consistency (alpha= 0.70-0.90) and shows 
significant increases over behavioral weight management treatment.
Weight Management Behaviors: We will examine expected dietary and physical activity behavioral 
differences between the three conditions, using 19 questions which will be rated on the self-reported 
frequency of use (1=never to 8=always), consistent with previous research.
Perceived Stress Scale: We will assess the degree to which participants find their lives to be stressful 
using the 10 item Perceived Stress Scale. Perceived Stress Scale scores have previously been shown to 
be related to smoking relapse.
Healthy Days Core Module: We will assess general health using the CDC Health-Related Quality of Life 4 
item measure.
International Physical Activity Questionnaire: We will assess self-reported physical activity using the 
International Physical Activity Questionnaire, as it has been validated against accelerometry and has 
good test-retest reliability.
Weight: At all measurement visits, weight will be recorded in kilograms. Weight will be measured on the 
Body Trace e-scale (except for at the Screening Visit) in duplicate, with the participant wearing light 
clothing and no shoes. 
Height: Height will be self-reported. BMI in kg/m2 will be calculated from measured weight and height.
Safety Measures: We will assess depressive symptoms using the 20-item CESD-R scale (75), which is a 
validated and frequently used self-report measure of depressive symptoms. Scores ≥16 are considered 
to be suggestive of clinically significant depression. In the event that someone reports worsening 
depression, suicidal ideation, or an adverse event, we will involve the study physician, Dr. Womack.  At 
measurement visits and monthly medication calls, we will assess adverse events and suicidality using 
the C-SSRS (76). We have a safety plan for management of depression and suicidal ideation, including 
follow-up to ensure that care has been obtained. 
Intervention & Varenicline Adherence: Process variables will be a critical element of the data collected, 
both to assure treatment fidelity and to inform potential dissemination of the intervention. 
Interventionists will carefully monitor session attendance, dietary/physical activity/weight self-
monitoring (if in Groups 1 or 2), meal replacement utilization (if in Group 2), and varenicline utilization 
to monitor implementation and to capture intervention exposure. Treatment engagement is a 
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consistent predictor of weight management success in our work and others (38, 97, 98); thus, we expect 
that treatment engagement will also be important in the management of postcessation weight gain. 
Program Satisfaction: Program satisfaction will be assessed to offer insight into program acceptability 
for each of the conditions and get feedback on specific intervention components. We propose to adapt 
the treatment satisfaction measure we are currently using in the Fit Blue study (39), which will inform 
program refinement and future implementation.
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