- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03156660
Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
-
Memphis, Tennessee, United States, 38105
- University of Tennessee Health Science Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Weight gain prevention (Group 1)
Small Changes weight stability intervention
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Participants will be asked to keep their weight stable during the initial 8 weeks of the study. Intervention Components:
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Experimental: Weight loss intervention (Group 2)
Look AHEAD weight loss intervention
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Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8. Intervention Components:
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Active Comparator: Self-guided intervention (Group 3)
Self-guided weight management with the EatingWell Diet book
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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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point Prevalence Tobacco Abstinence
Time Frame: 12 months from randomization
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Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.
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12 months from randomization
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Weight
Time Frame: 12 months from randomization
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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.
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12 months from randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Krukowski, PhD, University of Tennessee
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-04522-FB
- R01DK107747 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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