探索限时进食对南非感染艾滋病毒女性的体重及相关心脏代谢指标的影响（TESSA）：一项随机对照试验方案

Exploring the effects of ime-restricted ating on body weight and associated cardiometabolic outcomes in outh frican women living with HIV (TESSA): protocol for a randomised controlled trial.

作者信息

Mendham Amy E, Goedecke Julia H, Heckens Lorena, Hoosen Fatima, Pico Majken Lillholm, Kengne Andre P, Christensen Dirk L, Olesen Ole F, Quist Jonas Salling, Dave Joel, Færch Kristine, Groth Grunnet Louise

机构信息

Riverland Academy of Clinical Excellence, Riverland Mallee Coorong Local Health Network, Berri, South Australia, Australia

Health through Physical Activity, Lifestyle and Sport Research Centre (HPALS), FIMS International Collaborating Centre of Sports Medicine, Division of Physiological Sciences, Department of Human Biology, University of Cape Town, Cape Town, Western Cape, South Africa.

出版信息

BMJ Open. 2024 Dec 3;14(12):e086203. doi: 10.1136/bmjopen-2024-086203.

DOI:10.1136/bmjopen-2024-086203

PMID:39627134

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11624751/

Abstract

INTRODUCTION

We codesigned an intervention with a low-resourced community with the aim to investigate the effects of time-restricted eating (TRE) on changes in body weight and associated cardiometabolic outcomes in South African women living with overweight/obesity and HIV who have initiated dolutegravir (DTG)-based antiretroviral therapy (ART).

METHODS AND ANALYSIS

Women with overweight or obesity (body mass index ≥25 kg/m², no upper limit), aged 20-45 years, living with HIV and in a low-resourced community, and receiving DTG-based ART for less than 2 years will be recruited from a community healthcare centre in Khayelitsha, Cape Town (n=152). Participants will be randomised 1:1 to the TRE group (n=76) or standard of care control group (n=76) for 12 months. The TRE group will be required to restrict their eating window to ~8-10 hours/day and will receive nutritional information sessions at baseline and at 3, 6, 9 and 12 months. The primary outcome of body weight will be assessed at baseline and monthly. Cardiometabolic measures will be reported as secondary outcomes. At baseline, 6- and 12 months, an oral glucose tolerance test (to estimate insulin sensitivity and beta-cell function), questionnaires (sociodemographic, food insecurity, quality of life, social support and sleep quality) and a quantified food frequency questionnaire (total energy and macronutrient composition) will be completed. Every 3 months, appetite ratings, bioelectrical impedance (fat mass and fat-free mass), fasting venous bloods (glucose, insulin, gut hormones and systemic inflammation) and process evaluation (qualitative interviews) will be completed. Monthly monitoring will also include anthropometry and blood pressure.

ETHICS AND DISSEMINATION

The study is conducted in accordance with the Declaration of Helsinki and has been approved by the Human Research Ethics Committee of the University of Cape Town (628/2021). Verbal and written consent is required from study participants. Results of this study will be published in peer-reviewed journals and presented at conferences.

TRIAL REGISTRATION NUMBER

PACTR202302484999720.

摘要

引言

我们与一个资源匮乏的社区共同设计了一项干预措施，旨在调查限时进食（TRE）对超重/肥胖且感染艾滋病毒的南非女性体重变化及相关心脏代谢指标的影响，这些女性已开始接受基于度鲁特韦（DTG）的抗逆转录病毒疗法（ART）。

方法与分析

将从开普敦凯伊利沙的一个社区医疗中心招募年龄在20 - 45岁、超重或肥胖（体重指数≥25kg/m²，无上限）、感染艾滋病毒且生活在资源匮乏社区、接受基于DTG的ART治疗少于2年的女性（n = 152）。参与者将按1:1随机分为TRE组（n = 76）或标准护理对照组（n = 76），为期12个月。TRE组将被要求将进食窗口限制在每天约8 - 10小时，并在基线以及第3、6、9和12个月接受营养信息讲座。体重的主要结局将在基线和每月进行评估。心脏代谢指标将作为次要结局报告。在基线、6个月和12个月时，将完成口服葡萄糖耐量试验（以评估胰岛素敏感性和β细胞功能）、问卷（社会人口统计学、粮食不安全状况、生活质量、社会支持和睡眠质量）以及定量食物频率问卷（总能量和宏量营养素组成）。每3个月，将完成食欲评分、生物电阻抗（脂肪量和去脂体重）测量、空腹静脉血检测（血糖、胰岛素、肠道激素和全身炎症指标）以及过程评估（定性访谈）。每月监测还将包括人体测量和血压测量。