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Short Term Effect of Smoking Cessation on Human Metabolism

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ClinicalTrials.gov Identifier: NCT03446183
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborator:
Meuhedet. Healthcare Organization
Information provided by (Responsible Party):
Anna Aronis, Hebrew University of Jerusalem

Tracking Information
First Submitted Date February 15, 2018
First Posted Date February 26, 2018
Last Update Posted Date February 26, 2018
Actual Study Start Date April 18, 2016
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2018)
  • Change in weight [ Time Frame: 6 months from baseline ]
    Weight in meters
  • Change in BMI [ Time Frame: 6 months from baseline ]
    BMI in kg/m2
  • Change in waist and hip circumference [ Time Frame: 6 months from baseline ]
    Waist and hip curcumference in centimeters
  • Change in Blood fasting glucose according to patient files (unspecified time points up to a year before and a year after the workshops) [ Time Frame: up to 2 years from baseline ]
    BFG in mg/dl
  • Change in lipid profile according to patient files (unspecified time points up to a year before and a year after the workshops) [ Time Frame: up to 2 years from baseline ]
    Lipid particle measurements in mg/dl
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Short Term Effect of Smoking Cessation on Human Metabolism
Official Title Short Term Effect of Smoking Cessation on Human Metabolism
Brief Summary Investigating the short term smoking cessation on metabolism, examining of participant of smoking cessation workshops and former participants' file survey for metabolic aspects
Detailed Description

Objective: To examine metabolic aspects occurring during the first 6-12 months following smoking cessation in participants of smoking cessation workshops.

Design: A two armed study: prospective and retrospective. Prospective: Weight, BMI, waist circumference and waist: hip ratio were measured before, during and 6 months post cessation program. Retrospective: Blood test data for Blood fasting glucose (BFG) and lipid profile from the year preceding the workshops and the year after them were analyzed from participants' files. Smoking status was verified by phone conversation.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.
Condition
  • Smoking Cessation
  • Metabolic Syndrome
Intervention Behavioral: Smoking cessation workshops
All the participants took part in smoking cessation workshops. The comparison of metabolic aspects was made between the smokers and non-smokers
Study Groups/Cohorts
  • Smoking cessation prospective
    Smoking cessation workshops
    Intervention: Behavioral: Smoking cessation workshops
  • Smoking cessation retrospective
    File review of former workshop participants
    Intervention: Behavioral: Smoking cessation workshops
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2018)
308
Original Actual Enrollment Same as current
Actual Study Completion Date September 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.

Exclusion Criteria:

  • Candidates with benign tumors, bariatric surgeries, and endoscopic bariatric procedures before or during the study period were excluded
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03446183
Other Study ID Numbers smoking cessation
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: This was not a part of Helsinki Committee approval. Anonymization of data for sharing is not expected.
Responsible Party Anna Aronis, Hebrew University of Jerusalem
Study Sponsor Hebrew University of Jerusalem
Collaborators Meuhedet. Healthcare Organization
Investigators Not Provided
PRS Account Hebrew University of Jerusalem
Verification Date February 2018