Smoking Cessation, Weight Change, Body
Conditions
Brief summary
The study aims to randomize 400 participants to 1 of 3 arms: a) a weight stability intervention prior to smoking cessation (Group 1); b) a weight loss intervention prior to smoking 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.
Detailed description
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.
Interventions
BEHAVIORALWeight gain prevention (Group 1)
Participants will be asked to keep their weight stable during the initial 8 weeks of the study. Intervention Components: 1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day). 2. Daily self-monitoring of steps and number of Small Changes 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Fit Bit Alta activity trackers to self-monitor steps
BEHAVIORALWeight loss intervention (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. Tailored calorie and fat goals based on their baseline weight. 2. Daily dietary intake and physical activity self-monitoring using a website or app. 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention 5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions 6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day 7. Fit Bit Alta activity trackers to self-monitor steps
BEHAVIORALSelf-guided intervention (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. EatingWell Diet book. 2. Daily weight self-monitoring on the BodyTraceTM e-scale
Sponsors
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 have BP \< 150/95 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 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 or liver disease, unstable cardiovascular conditions, HIV, or history of cancer in last 5 years * 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 * Weight limit of 385 pounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 12 months from randomization | At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. |
| Point Prevalence Tobacco Abstinence | 12 months from randomization | Point prevalence (7 days without a cigarette, not even a puff) is an appropriate measure in measuring long term outcome in cessation induction trials. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weight Gain Prevention (Group 1) Small Changes weight stability intervention
Weight gain prevention (Group 1): Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
Intervention Components:
1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
2. Daily self-monitoring of steps and number of Small Changes
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Fit Bit Alta activity trackers to self-monitor steps | 109 |
| Weight Loss Intervention (Group 2) Look AHEAD weight loss intervention
Weight loss intervention (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. Tailored calorie and fat goals based on their baseline weight.
2. Daily dietary intake and physical activity self-monitoring using a website or app.
3. Daily weight self-monitoring on the BodyTraceTM e-scale
4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
7. Fit Bit Alta activity trackers to self-monitor steps | 110 |
| Self-guided Intervention (Group 3) Self-guided weight management with the EatingWell Diet book
Self-guided intervention (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. EatingWell Diet book.
2. Daily weight self-monitoring on the BodyTraceTM e-scale | 86 |
| Total | 305 |
Baseline characteristics
| Characteristic | Weight Gain Prevention (Group 1) | Weight Loss Intervention (Group 2) | Self-guided Intervention (Group 3) | Total |
|---|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 11.4 | 55.5 years STANDARD_DEVIATION 11.7 | 53.8 years STANDARD_DEVIATION 11.7 | 54.3 years STANDARD_DEVIATION 11.6 |
| Average number of cigarettes smoked per day | 16.3 number of cigarettes STANDARD_DEVIATION 8.3 | 15.9 number of cigarettes STANDARD_DEVIATION 8.4 | 15.7 number of cigarettes STANDARD_DEVIATION 8.8 | 15.9 number of cigarettes STANDARD_DEVIATION 8.5 |
| Baseline weight | 92.5 kilograms STANDARD_DEVIATION 21.6 | 88.2 kilograms STANDARD_DEVIATION 19.8 | 89.7 kilograms STANDARD_DEVIATION 19.9 | 90.2 kilograms STANDARD_DEVIATION 21.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107 Participants | 110 Participants | 82 Participants | 299 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 46 Participants | 36 Participants | 132 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 60 Participants | 45 Participants | 159 Participants |
| Region of Enrollment United States | 109 participants | 110 participants | 86 participants | 305 participants |
| Sex: Female, Male Female | 75 Participants | 72 Participants | 60 Participants | 207 Participants |
| Sex: Female, Male Male | 34 Participants | 38 Participants | 26 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 109 | 0 / 110 | 0 / 86 |
| other Total, other adverse events | 88 / 109 | 84 / 110 | 60 / 86 |
| serious Total, serious adverse events | 17 / 109 | 14 / 110 | 12 / 86 |
Outcome results
Primary
Point Prevalence Tobacco Abstinence
Point prevalence (7 days without a cigarette, not even a puff) is an appropriate measure in measuring long term outcome in cessation induction trials.
Time frame: 12 months from randomization
Population: Completers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Weight Gain Prevention (Group 1) | Point Prevalence Tobacco Abstinence | 39 Participants |
| Weight Loss Intervention (Group 2) | Point Prevalence Tobacco Abstinence | 49 Participants |
| Self-guided Intervention (Group 3) | Point Prevalence Tobacco Abstinence | 41 Participants |
Primary
Weight
At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes.
Time frame: 12 months from randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Gain Prevention (Group 1) | Weight | -0.24 kilograms | Standard Deviation 0.25 |
| Weight Loss Intervention (Group 2) | Weight | -1.11 kilograms | Standard Deviation 0.2 |
| Self-guided Intervention (Group 3) | Weight | 1.25 kilograms | Standard Deviation 0.27 |