Short Term Effect of Smoking Cessation on Human Metabolism

February 20, 2018 updated by: Anna Aronis, Hebrew University of Jerusalem
Investigating the short term smoking cessation on metabolism, examining of participant of smoking cessation workshops and former participants' file survey for metabolic aspects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: 6 months from baseline
Weight in meters
6 months from baseline
Change in BMI
Time Frame: 6 months from baseline
BMI in kg/m2
6 months from baseline
Change in waist and hip circumference
Time Frame: 6 months from baseline
Waist and hip curcumference in centimeters
6 months from baseline
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
up to 2 years from baseline
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
up to 2 years from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebrew University of Jerusalem

Collaborators

Meuhedet. Healthcare Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • smoking cessation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This was not a part of Helsinki Committee approval. Anonymization of data for sharing is not expected.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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