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Trial · NCT07398404

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryStudy enrollment to assess Feasibility16 weeksNumber of participants enrolled out of participants screened.
PrimaryMean number treatment sessions attended to assess Feasibility16 weeksMean number of treatment sessions attended.
PrimaryRetention to assess Feasibility16 weeksRetention will be measured as the percent of participants that attend the post treatment assessment.
PrimaryTreatment credibility to assess AcceptabilityWeek 4, Week 8, Week 12, Week 16
Treatment credibility will be assessed via self-report monthly. Acceptability measured as the percent of participants that agree the intervention is acceptable (0-100%, with higher scores being indicative of higher treatment credibility).
PrimaryTreatment satisfaction to assess AcceptabilityWeek 16
Treatment satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is satisfactory (0-100%, with higher scores being indicative of higher treatment satisfaction).
PrimaryPercent weight changeBaseline, Week 16, 6-month follow-upPercent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.
PrimarySmoking cessation, as measured by exhaled carbon monoxideBaseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-upSmoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
PrimarySmoking cessation, as measured by timeline followback interviewBaseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-upSmoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.
SecondaryNicotine dependence, as measured by the Fagerstrom Test for Nicotine DependenceBaseline, Week 16, 6-month follow-up
The Fagerstrom Test for Nicotine Dependence is a self-report measure that classifies level of nicotine dependence. Participants respond to a series of questions assessing time of first cigarette after waking, difficulty refraining from smoking in places where smoking is prohibited, and frequency of smoking. Total score range 0-10 with higher scores indication more nicotine dependence.
SecondaryDepressive symptomatology, as measured by the Patient Health Questionnaire-9Baseline, Week 16, 6-month follow-up
The Patient Health Questionnaire-9 is a brief, psychometrically sound, and widely used self-report measure of depression in diverse medical settings. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
SecondaryPhysical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)Baseline, Week 16, 6-month follow-up
GPAQ is a validated self-report assessment of physical activity and sedentary behavior. GPAQ does not have a single fixed total score range but a score is calculated in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week.
SecondaryNumber of participants with Bariatric surgery completion6-month follow-upBariatric surgery completion will be assessed at 6-month follow-up, through medical record review.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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