NCT03446183

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 15, 2018

Last Update Submit

February 20, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in weight

    Weight in meters

    6 months from baseline

  • Change in BMI

    BMI in kg/m2

    6 months from baseline

  • Change in waist and hip circumference

    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)

    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)

    Lipid particle measurements in mg/dl

    up to 2 years from baseline

Study Arms (2)

Smoking cessation prospective

Smoking cessation workshops

Behavioral: Smoking cessation workshops

Smoking cessation retrospective

File review of former workshop participants

Behavioral: Smoking cessation workshops

Interventions

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

Smoking cessation prospectiveSmoking cessation retrospective

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking CessationMetabolic Syndrome

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 26, 2018

Study Start

April 18, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

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