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CompletedNCT03446183Updated Feb 26, 2018

Short Term Effect of Smoking Cessation on Human Metabolism

An observational study in Smoking Cessation and Metabolic Syndrome, sponsored by Hebrew University of Jerusalem. Completed. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Hebrew University of Jerusalem · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
308
Ages
25 Years to 70 Years
Sex
All
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Study summary

Investigating the short term smoking cessation on metabolism, examining of participant of smoking cessation workshops and former participants' file survey for metabolic aspects

Read the 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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Conditions studied

  • Smoking Cessation
  • Metabolic Syndrome

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03

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Candidates with benign tumors, bariatric surgeries, and endoscopic bariatric procedures before or during the study period were excluded
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
308 participants (actual)
Patient registry
No

Groups and cohorts

  • Smoking cessation prospective

    Smoking cessation workshops

    Behavioral: Smoking cessation workshops

  • Smoking cessation retrospective

    File review of former workshop participants

    Behavioral: Smoking cessation workshops

Interventions

  • BehavioralSmoking cessation workshops

    All the participants took part in smoking cessation workshops. The comparison of metabolic aspects was made between the smokers and non-smokers

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What researchers measure

Primary outcomes

  1. Change in weight

    Weight in meters

    Time frame: 6 months from baseline

  2. Change in BMI

    BMI in kg/m2

    Time frame: 6 months from baseline

  3. Change in waist and hip circumference

    Waist and hip curcumference in centimeters

    Time frame: 6 months from baseline

  4. Change in Blood fasting glucose according to patient files (unspecified time points up to a year before and a year after the workshops)

    BFG in mg/dl

    Time frame: up to 2 years from baseline

  5. Change in lipid profile according to patient files (unspecified time points up to a year before and a year after the workshops)

    Lipid particle measurements in mg/dl

    Time frame: up to 2 years from baseline

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 14, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — This was not a part of Helsinki Committee approval. Anonymization of data for sharing is not expected.

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Registry details

Key details

Study ID
NCT03446183
Lead sponsor
Hebrew University of Jerusalem
Collaborators
Meuhedet. Healthcare Organization
Responsible party
Anna Aronis (Senior Lecturer, Hebrew University of Jerusalem) — Principal investigator
First posted
Feb 26, 2018
Start date
Apr 18, 2016
Primary completion
Sep 1, 2017
Completion
Sep 1, 2017
Last update
Feb 26, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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