A multicomponent smoking cessation program for adults with Type 2 Diabetes Mellitus (DiMe-SALUD2 project): A study protocol of a randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-08-28 DOI:10.1016/j.conctc.2024.101361

Carla López-Núñez , Sergio Fernández-Artamendi , Desirée Ruiz-Aranda , Davinia María Resurrección , Desirée Navas-Campaña

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Abstract

Background

Tobacco use represents a significant public health burden, being especially harmful for smokers with Type 2 Diabetes Mellitus (T2DM). Effective smoking cessation interventions are required for this vulnerable population. The goal is to describe a study protocol of a randomized controlled trial (RCT) aimed at analyzing the effectiveness and efficiency of a multicomponent smoking cessation intervention for T2DM smokers, including a training protocol on healthy lifestyle habits and self-management of T2DM (DiMe-SALUD2 project).

Methods

This RCT will assign participants to: (1) Control Group (n = 30), including a brief psychoeducation advice about smoking cessation; (2) Cognitive-behavioral treatment (CBT) for smoking cessation (n = 30), based on a multicomponent program implemented in group-based sessions over an eight-week period; and (3) CBT plus DiMeSALUD2 protocol (n = 30), which will develop an additional psychoeducational protocol specifically designed to improve healthy lifestyle habits. Participants will be assessed at baseline, post-treatment and several follow-ups (1-, 6- and 12-months). Primary outcomes will include smoking abstinence (24-h point prevalence abstinence at post-treatment and 7-day point prevalence at follow-ups) and smoking continuous abstinence. Secondary outcomes will include treatment retention, changes in smoking patterns and nicotine dependence, as well as the impact on T2DM clinical variables, mental health, and quality of life.

Discussion

The DiMeSALUD2 program could assist T2DM smokers in quitting tobacco use and improving their overall quality of life. This project will help incorporating improvements in routine clinical practice with T2DM patients, offering a smoking cessation program adapted to their specific needs.

Trial registration

ClinicalTrials.gov. Identifier: NCT05885659. Date of registration: June 2nd, 2023.

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针对 2 型糖尿病成人的多成分戒烟计划（DiMe-SALUD2 项目）：随机对照试验研究方案

背景吸烟是一项重大的公共卫生负担，对患有 2 型糖尿病（T2DM）的吸烟者危害尤其严重。对于这一弱势群体，需要采取有效的戒烟干预措施。本研究旨在描述一项随机对照试验（RCT）的研究方案，旨在分析针对 T2DM 吸烟者的多成分戒烟干预措施的有效性和效率，包括健康生活习惯和 T2DM 自我管理的培训方案（DiMe-SALUD2 项目）。方法这项 RCT 将把参与者分配到：（1）对照组（n = 30），包括关于戒烟的简短心理教育建议；（2）戒烟认知行为治疗（CBT）（n = 30），基于在为期八周的小组会议中实施的多组分方案；（3）CBT 加 DiMeSALUD2 方案（n = 30），该方案将制定专门用于改善健康生活习惯的额外心理教育方案。参与者将在基线、治疗后和多次随访（1 个月、6 个月和 12 个月）时接受评估。主要结果包括戒烟率（治疗后 24 小时点戒烟率和随访时 7 天点戒烟率）和持续戒烟率。次要结果将包括治疗保持率、吸烟模式和尼古丁依赖的变化，以及对T2DM临床变量、心理健康和生活质量的影响。讨论DiMeSALUD2项目可帮助T2DM吸烟者戒烟并改善他们的整体生活质量。该项目将有助于改善T2DM患者的常规临床实践，提供适合其特殊需求的戒烟计划。标识符：NCT05885659。注册日期：注册日期：2023 年 6 月 2 日。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.