iSTEP: an mHealth Physical Activity and Diet Intervention for Persons with HIV

摘要/摘要 艾滋病毒携带者(PLWH)经历了神经认知缺陷和艾滋病毒的高发- 相关的非艾滋病(HANA)疾病，包括心血管疾病(CVD)、代谢功能障碍、 以及自主神经功能衰退。虽然抗逆转录病毒治疗(ART)减少了艾滋病相关的发病率，但 病毒和药物与血脂紊乱有关，后者也增加了心血管疾病的风险，包括 血脂异常和脂肪营养不良。因此，制定有效的生活方式干预措施，以减少 HIV相关神经认知障碍(HAND)和减少代谢障碍的发生率是 高优先级。体力活动(PA)已被用作改善PLWH健康的有效工具，但 可能不足以改善血脂水平。PLWH现有的PA干预措施通常需要 繁重的PA和大量的资源限制了许多患有这种疾病的人的可行性。近期 研究表明，与PA无关的久坐行为中断(SB)也有 对代谢功能有显著的有益影响，但SB在PWLH中尚未得到很好的研究。 地中海式饮食(MedDiet)在改善未感染艾滋病毒的心血管疾病风险因素方面也很有效 据报道，这种药物可以减少阿尔茨海默病高危人群的认知能力下降，但 没有在PWLH中进行广泛测试。我们最近开发了一种新颖的个性化短消息服务 (短信)手机短信干预(ISTEP)，旨在增加 PLWH(R21MH100968)。我们的目标是扩展这项工作，并进行一次RCT审查 ISTEP与针对PLWH量身定做的移动mHealth MedDiet干预相结合的疗效。180 PLWH 将被随机分配到对照组(n=60)，这是一个为期6个月的ISTEP组，仅有PA/SB 干预(n=60)，或同时使用PA/SB和MedDiet成分的6个月干预(n=60)，其中 参与者每天都会收到交互式短信/彩信，旨在增加适度的PA，减少SB， 并促进遵守MedDiet，包括核桃消费。Pa/Sb将被量化为 加速计、Fitbit步数和自我报告、MedDiet遵守情况将通过自我报告(Diet)进行评估 历史问卷和每周短信反馈)和客观指标(多不饱和脂肪酸 血液中的多不饱和脂肪酸水平)，我们将量化代谢和炎症标志物。我们还将进行一次 干预结束6个月后的随访评估(加速计、神经认知测试、 多不饱和脂肪酸水平)，以评估PA和MedDiet的依从性。我们假设ISTEP(两个干预部门) 与对照组相比，将增加PA，减少SB，并改善神经认知；ISTEP+MedDiet组 将显示与PA/SB干预相比，心血管疾病危险因素和神经认知方面的改善 独自一人。这一提案的发现将为开发新型大规模移动通信设备奠定基础 PA/饮食干预致力于治疗手部和改善PLWH的心血管健康。

SUMMARY/ABSTRACT People who live with HIV (PLWH) experience a high incidence of neurocognitive deficits and HIV- associated non-AIDS (HANA) disorders, including cardiovascular disease (CVD), metabolic dysfunction, and autonomic decline. While antiretroviral treatment (ART) has reduced AIDS-related morbidity, both the virus and the medications are associated with lipid disorders that also increase CVD risk, including dyslipidemia and lipodystrophy. Consequently, the development of effective lifestyle interventions to reduce the incidence of HIV-associated neurocognitive disorders (HAND) and decrease metabolic disorders is a high priority. Physical activity (PA) has been utilized as an effective tool to improve health in PLWH, but may not be sufficient by itself to improve lipid levels. Existing PA interventions in PLWH typically required strenuous PA and significant resources that limit feasibility for many people living with the disease. Recent work indicates that interrupting periods of sedentary behavior (SB), independent of PA, also has a significant beneficial effect on metabolic function, but SB has not been well-studied in PWLH. Mediterranean-style diets (MedDiet) are also effective at improving CVD risk factors in HIV-uninfected individuals and are reported to reduce cognitive decline in persons at risk for Alzheimer's disease, but have not been widely tested in PWLH. We recently developed a novel and personalized Short Message Service (SMS) mobile phone text messaging intervention (iSTEP) that is designed to increase moderate PA in PLWH (R21MH100968). Our objective is to expand upon this work and conduct an RCT examining the efficacy of iSTEP in combination with a mobile mHealth MedDiet intervention tailored to PLWH. 180 PLWH will be randomly assigned to a control group (n = 60), a 6-month iSTEP group with just a PA/SB intervention (n = 60), or a 6-month intervention with both PA/SB and MedDiet components (n = 60), where participants receive daily interactive SMS/MMS messages designed to increase moderate PA, reduce SB, and promote adherence to a MedDiet, including walnut consumption. PA/SB will be quantified by accelerometer, Fitbit step counts, and self-report, MedDiet adherence will be assessed by self-report (Diet History Questionnaire and weekly SMS feedback) and objective measures (polyunsaturated fatty acid levels - PUFA in blood), and we will quantify metabolic and inflammatory markers. We will also conduct a follow-up assessment 6 months after the end of the intervention (accelerometer, neurocognitive testing, PUFA levels) to assess PA and MedDiet adherence. We hypothesize that iSTEP (both intervention arms) will increase PA, reduce SB, and improve neurocognition compared to control; the iSTEP + MedDiet group will demonstrate improvement in CVD risk factors and neurocognition compared to the PA/SB intervention alone. Findings from this proposal will lay the groundwork for development of novel large-scale mobile PA/diet interventions dedicated to treating HAND and improving cardiovascular health for PLWH.