Diabetes and Smoking Cessation: a Gender-Oriented Study

NCT03426423 | Terminated

• 1 other identifier: 2017-00812
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

People with diabetes still smoke at equivalent rates as non-diabetics. There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes. The aim of this project is to assess the 12 months efficacy of a smoking cessation intervention tailored to diabetes and gender specificities, in a population of 500 smokers with type 2 diabetes. The secondary objectives are to assess the impact of smoking cessation on anthropometric outcomes, diabetes control and renal function and fecal microbiota.

Conditions

Smoking Cessation; Diabetes Type 2

Keywords

Gender; Metabolism; Microbiota

Outcome Measures

Primary Outcomes (1)

• Continuous smoking abstinence

  continuous abstinence rate from week 12 (end of intervention) to week 52 (end of follow-up), defined as self-report of no smoking or use of other nicotine containing products (ENDS, smokeless tobacco) since the previous visit or contact, confirmed by expired monoxide level \< 10 ppm.

  Measured at 52 weeks

Secondary Outcomes (23)

• Point prevalence smoking abstinence

  Change is measured at 12 week

• Point prevalence smoking abstinence

  Change is measured at 26 weeks

• Point prevalence smoking abstinence

  Change is measured at 52 weeks

• Motivation to quit smoking

  Change is measured from baseline to 12 week

• Motivation to quit smoking

  Change is measured from baseline to 26 week

Other Outcomes (3)

• Exploratory microbiota outcome

  Change is measured from baseline to 4 weeks.

• Exploratory microbiota outcome

  Change is measured from baseline to 8 weeks.

• Exploratory microbiota outcome

  Change is measured from baseline to 26 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

12 weeks smoking cessation intervention tailored to diabetic and gender specificities, delivered by a study nurse.

Other: Behavioral smoking cessation intervention

Control

ACTIVE COMPARATOR

Usual care comprising a unique intervention of 5-10 minutes, non tailored smoking cessation intervention, delivered by a study nurse.

Other: Control

Interventions

Behavioral smoking cessation intervention OTHER

The intervention consists in a behavioral smoking cessation intervention combined with pharmacotherapy. The intervention is tailored it to specificities of participants based on findings from the previous phase of our study (DISCGO-MIX, Swissethics ID PB\_2016-01459). Counseling will cover topics such as assessing ambivalence and enhancing motivation with motivational interviewing methods, identifying barriers to quit, coping with cravings and intensive relapse prevention strategies. Participants will be advised to use over the counter nicotine replacement bi-therapy (NTR). A 2-week starting kit, consisting of nicotine transdermal patch and a short acting NRT (lozenge, gums, inhaler or mouth spray) will be provided to participants for free, if they wish to take NRT. The behavioral intervention will last 30-45 minutes, and will be conducted by a research nurse using an interview guide.

Intervention

Control OTHER

Participants assigned to the control group will receive a less intensive and non-tailored intervention for smoking cessation. For this arm the structured 3 steps AAR approach will be used: Ask for smoking status. Advise to quit in a clear manner. Refer to external help: participants will receive a booklet with information on smoking cessation (non specific to diabetes and gender) and links to support facilities (national quitline, smoking cessation clinic, websites, self-help). This unique intervention of 5-10 minutes will be performed by the research nurse.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identification is based on self-representation of gender eligibility with the possibility to self identify as transgender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature;
• Having smoked \> 100 cigarettes during his/her entire life and currently smoking cigarettes (no minimal threshold);
• Having been diagnosed with a type 2 diabetes;
• Being ≥ 18 years old;
• Speaking and understanding French

You may not qualify if:

• Not being able to give an informed consent and follow the procedure of the study (due to dementia, psychological disorder, language problem);
• Being pregnant or breastfeeding;
• Being enrolled in another smoking cessation study or program or in a multi-behavioral program including smoking cessation;
• Enrolment of the investigator or other research collaborators, their family members, employees and other dependent persons;
• Planning to move out of Switzerland within the next year.

Sponsors & Collaborators

• Carole Clair: lead

Study Sites (1)

Center for Primary Care and Public Health

Lausanne, Canton of Vaud, 1010, Switzerland

Location

Related Publications (1)

• Clair C, Augsburger A, Birrer P, Locatelli I, Schwarz J, Greub G, Zanchi A, Jacot-Sadowski I, Puder JJ. Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT). BMJ Open. 2020 Nov 19;10(11):e040117. doi: 10.1136/bmjopen-2020-040117.

  PMID: 33444198 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Diabetes Mellitus, Type 2; Coitus

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sexual Behavior

Study Officials

• Carole Clair, MD, MSc

  Center for Primary Care and Public Health, Lausanne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: According to the article 18 of the LRH, participants will not be given the full information regarding the main purpose of the study (assess the efficacy of a smoking cessation trial) in order not to influence participants regarding the intervention and also to decrease selection bias (only smokers motivated to quit would take part and thus induce a selection bias). Methodologically, such a blinding to procedure would allow a better assessment of its efficacy. Furthermore, risks associated to the intervention are considered as very low. Participants will be informed a posteriori once they have completed the study or before in case they remove their consent or quit the study. The outcome assessor will be a research collaborator independent of the study nurse who performed the intervention and blinded to the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 8, 2018
• Study Start: March 1, 2018
• Primary Completion: December 15, 2020
• Study Completion: March 10, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)