Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy
Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
BMJ Open. 2024 Sep 10;14(9):e086866. doi: 10.1136/bmjopen-2024-086866.
Weight gain, together with the onset of overweight and obesity, is a relevant emerging health issue among people living with HIV (PLWH). A large body of literature recognises this issue as a part of the secondary effects of some antiretroviral therapy (ART), but little is known about the role of lifestyle. In order to assess the role of modifiable aspects of lifestyle in addition to ART on the onset of overweight and obesity, we designed a prospective observational study among PLWH.
This is a prospective observational study among PLWH aged 18-65 years attending the Clinic of Infectious Diseases of Spedali Civili, Brescia, Italy, and on ART for at least 24 months. According to the sample size computation, 175 PLWH will be enrolled. PLWH willing to participate in the study are invited to a scheduled clinical visit to collect anthropometric measures, dietary habits and physical activity levels. During the visit, standardised and validated questionnaires are administered regarding emotional distress, food insecurity, use of food supplements, sleep quality, smoking habit and alcohol consumption/risk of addiction. After the interviews, bioimpedance analysis is performed and blood pressure and heart rate are assessed. After 12 months from baseline, each participant will be asked to participate in a further visit, with the same assessments as at baseline. The primary objective of the study is to assess the role of the modifiable factors of lifestyle in the onset of overweight and/or obesity among on-treatment PLWH experiencing weight gain, focusing on diet and physical activity.
The study research protocol and informed consent procedures were approved by Ethics Committee of Brescia Province (Italy) on 23 May 2023 (NP5892). Informed consent will be obtained from participants. Results will be submitted for publication in international peer-reviewed journals and summaries will be provided annually to the funders.
体重增加以及超重和肥胖的发生，是 HIV 感染者（PLWH）中一个相关的新兴健康问题。大量文献认识到这一问题是某些抗逆转录病毒疗法（ART）的次要影响的一部分，但对于生活方式的作用知之甚少。为了评估除 ART 以外的生活方式的可改变方面对超重和肥胖发生的作用，我们在 PLWH 中设计了一项前瞻性观察研究。
这是一项在意大利布雷西亚 Spedali Civili 传染病诊所接受 ART 治疗至少 24 个月、年龄在 18-65 岁之间的 PLWH 的前瞻性观察研究。根据样本量计算，将招募 175 名 PLWH。愿意参与研究的 PLWH 被邀请参加预约的临床就诊，以收集人体测量指标、饮食习惯和身体活动水平。在就诊期间，将针对情绪困扰、食物不安全、使用食物补充剂、睡眠质量、吸烟习惯和酒精摄入/成瘾风险等问题进行标准化和验证过的问卷调查。访谈结束后，进行生物阻抗分析并评估血压和心率。在基线后 12 个月，要求每位参与者参加进一步的就诊，进行与基线相同的评估。该研究的主要目的是评估治疗中出现体重增加的 PLWH 生活方式的可改变因素（重点是饮食和身体活动）在超重和/或肥胖发生中的作用。
该研究的研究方案和知情同意程序已于 2023 年 5 月 23 日获得布雷西亚省（意大利）伦理委员会的批准（NP5892）。将从参与者那里获得知情同意。研究结果将提交给国际同行评审期刊发表，并将每年向资助者提供摘要。
