Diabetes and Smoking Cessation: a Gender-Oriented Study

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

Interventions

OTHER

Behavioral smoking cessation intervention

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.

OTHER

Control

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.

Sponsors & Collaborators

• Carole Clair

  lead OTHER

Principal Investigators

• Carole Clair, MD, MSc · Center for Primary Care and Public Health, Lausanne University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2020-12-15

Completion

2021-03-10

Countries

• Switzerland

Study Locations