Rethorst Chad D, Githinji Phrashiah, Seguin-Fowler Rebecca A, MacMillan Uribe Alexandra L, Szeszulski Jacob, Liao Yue
Institute for Advancing Health Through Agriculture, Texas A&M AgriLife Research, Dallas, TX, United States.
Institute for Advancing Health Through Agriculture, Texas A&M AgriLife Research, College Station, TX, United States.
JMIR Res Protoc. 2023 Mar 22;12:e45104. doi: 10.2196/45104.
Glucose variability increases cardiometabolic disease risk. While many factors can influence glucose levels, postprandial glucose response is the primary driver of glucose variability. Furthermore, affect may directly and indirectly impact glucose variability through its effect on eating behavior. Continuous glucose monitors (CGMs) facilitate the real-time evaluation of blood glucose, and ecological momentary assessment (EMA) can be used to assess affect in real time. Together, data collected from these sources provide the opportunity to further understand the role of affect in glucose levels.
This paper presents the protocol for a study that aims to (1) evaluate the feasibility and acceptability of using CGMs along with EMA in nondiabetic populations and (2) examine the bidirectional relationship between affect and glucose in nondiabetic adults with overweight or obesity using a CGM and EMA.
Eligibility criteria for the study include participants (1) aged 18 to 65 years old, (2) with a BMI of ≥25 kg/m, (3) who are able to read and write in English, and (4) who own a smartphone. Individuals will be excluded if they (1) have type 1 or 2 diabetes or have any other condition that requires glucose monitoring, (2) are pregnant, (3) use any medications that have the potential to alter blood glucose levels or interfere with the glucose sensing process, or (4) have a diagnosed gastrointestinal condition or eating disorder. In a 14-day observational study, participants will wear a FreeStyle Libre Pro CGM sensor (Abbott) and will receive mobile phone-based EMA prompts 6 times per day (randomly within six 2-hour windows between 8 AM and 8 PM) to assess positive and negative affect. Participants will also wear a Fitbit Inspire 2 (Fitbit) to continuously monitor physical activity and sleep, which will be included as covariates in the analysis. Multilevel linear regression models will be used to evaluate the acute relationship between glucose level and affect.
Recruitment started in October 2022 and is expected to be completed in March 2023. We will aim to recruit 100 participants. As of December 12, 2022, a total of 39 participants have been enrolled.
The results of this study will further elucidate the role of affect in glucose variability. By identifying affective states that may lead to glucose excursions, our findings could inform just-in-time behavioral interventions by indicating opportunities for intervention delivery.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45104.
血糖变异性会增加心血管代谢疾病风险。虽然许多因素会影响血糖水平，但餐后血糖反应是血糖变异性的主要驱动因素。此外，情绪可能通过对饮食行为的影响直接或间接影响血糖变异性。持续葡萄糖监测仪（CGM）有助于实时评估血糖，而生态瞬时评估（EMA）可用于实时评估情绪。综合从这些来源收集的数据，为进一步了解情绪在血糖水平中的作用提供了机会。
本文介绍了一项研究方案，旨在（1）评估在非糖尿病人群中同时使用CGM和EMA的可行性和可接受性，以及（2）使用CGM和EMA研究超重或肥胖的非糖尿病成年人情绪与血糖之间的双向关系。
该研究的纳入标准包括参与者（1）年龄在18至65岁之间，（2）体重指数（BMI）≥25kg/m²，（3）能够用英语读写，以及（4）拥有智能手机。如果个体（1）患有1型或2型糖尿病或有任何其他需要血糖监测的疾病，（2）怀孕，（3）使用任何有可能改变血糖水平或干扰葡萄糖传感过程的药物，或（4）被诊断患有胃肠道疾病或饮食失调，则将被排除。在一项为期14天的观察性研究中，参与者将佩戴FreeStyle Libre Pro CGM传感器（雅培公司），并每天接受6次基于手机的EMA提示（在上午8点至晚上8点之间的六个2小时时间段内随机进行），以评估积极和消极情绪。参与者还将佩戴Fitbit Inspire 2（Fitbit）来持续监测身体活动和睡眠，这些将作为协变量纳入分析。多级线性回归模型将用于评估血糖水平与情绪之间的急性关系。
招募工作于2022年10月开始，预计于2023年3月完成。我们的目标是招募100名参与者。截至2022年12月12日，已招募了39名参与者。
本研究结果将进一步阐明情绪在血糖变异性中的作用。通过识别可能导致血糖波动的情绪状态，我们的研究结果可为即时行为干预提供依据，指明干预实施的时机。
国际注册报告识别码（IRRID）：DERR1-10.2196/45104。
