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Trial record 4 of 2035 for:    Smoking Cessation

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

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

Condition or disease Intervention/treatment
Smoking Cessation Metabolic Syndrome Behavioral: Smoking cessation workshops

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.


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Study Type : Observational
Actual Enrollment : 308 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Short Term Effect of Smoking Cessation on Human Metabolism
Actual Study Start Date : April 18, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Smoking cessation prospective
Smoking cessation workshops
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

Smoking cessation retrospective
File review of former workshop participants
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




Primary Outcome Measures :
  1. Change in weight [ Time Frame: 6 months from baseline ]
    Weight in meters

  2. Change in BMI [ Time Frame: 6 months from baseline ]
    BMI in kg/m2

  3. Change in waist and hip circumference [ Time Frame: 6 months from baseline ]
    Waist and hip curcumference in centimeters

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Study Documents (Full-Text)

Documents provided by Anna Aronis, Hebrew University of Jerusalem:

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Responsible Party: Anna Aronis, Senior Lecturer, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier: NCT03446183     History of Changes
Other Study ID Numbers: smoking cessation
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases