Smoking CessationNCT03446183
Short Term Effect of Smoking Cessation on Human Metabolism
An observational study of Smoking Cessation and Metabolic Syndrome, run by Hebrew University of Jerusalem.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Metabolic Syndrome
- What is being tested?
- Smoking cessation workshops
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2016to 1 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.
Who may be able to join
- Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.
Who cannot join
- Candidates with benign tumors, bariatric surgeries, and endoscopic bariatric procedures before or during the study period were excluded
About this study
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.
- Conditions
- Smoking Cessation, Metabolic Syndrome
- Being tested
- Smoking cessation workshops
- Medical subject headings
- Smoking Cessation, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation workshopsBehavioural
All the participants took part in smoking cessation workshops. The comparison of metabolic aspects was made between the smokers and non-smokers
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation prospective | Smoking cessation workshops Receives: Behavioral: Smoking cessation workshops | |
| Smoking cessation retrospective | File review of former workshop participants Receives: Behavioral: Smoking cessation workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Weight in meters
Measured: 6 months from baseline
Change in BMI
BMI in kg/m2
Measured: 6 months from baseline
Change in waist and hip circumference
Waist and hip curcumference in centimeters
Measured: 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
Measured: 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
Measured: up to 2 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start18 Apr 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Collaborators
- Meuhedet. Healthcare Organization
- Responsible party
- Principal investigator, Anna Aronis, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446183
- Sponsor's protocol ID
- smoking cessation
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not a part of Helsinki Committee approval. Anonymization of data for sharing is not expected.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Smoking Cessation on Human Metabolism
- ClinicalTrials.gov ID
- NCT03446183
- Acronym / sponsor ID
- smoking cessation
- Conditions
- Smoking Cessation, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Collaborators
- Meuhedet. Healthcare Organization
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation prospective | – | Behavioral: Smoking cessation workshopsSmoking cessation workshops |
| Smoking cessation retrospective | – | Behavioral: Smoking cessation workshopsFile review of former workshop participants |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.
Key inclusion criteria (1 listed)
- Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO (Israeli Health Services) during 2016-2017.
Key exclusion criteria (1 listed)
- Candidates with benign tumors, bariatric surgeries, and endoscopic bariatric procedures before or during the study period were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation workshopsAll the participants took part in smoking cessation workshops. The comparison of metabolic aspects was made between the smokers and non-smokers | Behavioural | Smoking cessation prospective, Smoking cessation retrospective |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: No. This was not a part of Helsinki Committee approval. Anonymization of data for sharing is not expected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Metabolic Syndrome, run by Hebrew University of Jerusalem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: 6 months from baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.