Protocol for the LIFEH project: a prospective observational study to explore lifestyle among people living with HIV experiencing weight gain, looking beyond antiretroviral therapy.

Introduction: 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.

Methods And Analysis: 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.

Ethics And Dissemination: 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.