Accepted for/Published in: JMIR Formative Research
Date Submitted: Jun 16, 2022
Date Accepted: Mar 23, 2023
Date Submitted to PubMed: Mar 24, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: A Randomized Controlled Trial
ABSTRACT
Background:
Given the importance of self-management in type 2 diabetes (T2D), a major aspect of health is providing diabetes self-management education and support (DSME/S). There are known barriers including access, availability, and lack of follow through on referral to education programs. Virtual education and support have increased in use, particularly over the last few years.
Objective:
The purpose of the Diabetes LIVE (Learning in a Virtual Environment) study was to compare the effects of the LIVE intervention (educational 3D world) on diet and physical activity behaviors, behavioral and metabolic outcomes in adults with T2D over 12 months to an online DSME/S control website.
Methods:
The LIVE study was a 52-week multi-site randomized controlled trial with longitudinal repeated measures. Participants were randomized to Diabetes LIVE (n =101) or a web control site (n=110). Both contained the same educational materials, but the VE was synchronous and interactive and the other was a flat website. Data were collected at baseline, 3, 6, and 12 months using surveys, clinical, laboratory, and Fitbit measures. Descriptive statistics for baseline characteristics and demographics were used. The effects of the intervention on outcomes were initially examined by comparing the means and standard deviations across the four time points of the outcomes between study arms, followed by multilevel modeling on trajectories of the outcomes over the 12 months.
Results:
211 participants consented to participate in this trial. The mean age of participants was 58.85 (+10.1) years, and a majority were White (60.2%), non-Hispanic (93.8%), married (56.3%), and female (59.2%). Mean A1c at baseline was 7.64% (+1.79) and the mean BMI was 33.51 (+7.25). We examined weight loss status vs. randomized group, where data with no weight change were eliminated, and we found a statistically significant difference with the LIVE group experiencing more weight loss than the WebControl group (P=.04). There were no statistically significant differences between groups in changes in physical activity and dietary outcomes, but each group showed an increase in physical activity. Both groups experienced a decrease in mean A1c, systolic and diastolic blood pressure, cholesterol, and triglycerides over the course of 12 months of study participation, including those participants whose baseline A1c was 8.6 or higher.
Conclusions:
This study confirmed that there were minor positive changes on metabolic control in both groups over the 12-month study period, however, the majority of the participants began with good metabolic control. We did find clinically relevant metabolic changes in those who began with an A1c level >8.6% in both groups. This study provided a variety of resources to our participants in both study groups, and we conclude that a toolkit with a variety of services would be helpful to improving self-care in the future for persons with T2D. Clinical Trial: Clinical Trials.Gov nCT02040038
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