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January 26, 2023JMIR Research Protocols3 citationsOpen Access

Real-time Assessment of the Bidirectional Relationship Between Affective States and Glucose: Protocol for a 14-Day Observational Study

CRChad D. RethorstPGPhrashiah GithinjiRSRebecca A. Seguin‐Fowler

Key Result

Continuous glucose monitoring and ecological momentary assessment will be utilized in a 14-day observational study of 100 individuals to evaluate the bidirectional relationship between mood states and glucose.

Study Design

Type

Observational (n=100)

Multicenter

No

Structured PICO

What is the bidirectional relationship between affective states and glucose levels in nondiabetic adults with overweight or obesity?

P
Population
Nondiabetic adults with overweight or obesity, able to read and write in English, and who own a smartphone. Exclusions: type 1 or 2 diabetes, pregnant, medications altering blood glucose, diagnosed gastrointestinal condition or eating disorder. Target n=100.
I
Intervention
14-day observational period wearing a FreeStyle Libre Pro continuous glucose monitor (CGM) sensor, receiving mobile phone-based ecological momentary assessment (EMA) prompts 6 times per day to assess affect, and wearing a Fitbit Inspire 2 to monitor physical activity and sleep.
O
Outcome
Feasibility and acceptability of using CGMs along with EMA in nondiabetic populations, and the bidirectional relationship between affect and glucose.surrogate

This protocol outlines a 14-day observational study to evaluate the feasibility of using continuous glucose monitors and ecological momentary assessment to understand the bidirectional relationship between affect and glucose in nondiabetic adults with overweight or obesity.

Limitations

  • Unclear how non-compliance with prompt responses or study dropout will be handled
  • Unclear how timing of meals or time-restricted feeding regimens will be addressed

Abstract

BACKGROUND: 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. OBJECTIVE: 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. METHODS: , (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. RESULTS: 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. CONCLUSIONS: 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.

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Cite This Study

Rethorst et al. (2023) conducted an observational in Affective states and glucose (n=100). Continuous glucose monitoring (CGM) and ecological momentary assessment (EMA) was evaluated on Bidirectional relationship between affective states and glucose. Continuous glucose monitoring and ecological momentary assessment will be utilized in a 14-day observational study of 100 individuals to evaluate the bidirectional relationship between mood states and glucose.

synapsesocial.com/papers/6a1bfd83fc87fd06169cf936https://doi.org/10.2196/45104
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