Obesity Clinical Trial
Official title:
Improving Physical Activity Behavior in Patients With High Cardio-metabolic Risk Using a Multi-modal mHealth Intervention: a 2-arm Randomized Controlled Trial
The goal of this study is to explore the effects of FeatForward on physical activity and cardio-metabolic risk factors. The study will be implemented as a 2-arm randomized controlled trial (RCT) comparing the effects of FeatForward in patients assigned to use the application versus a control group who will not use the app over a 6-month follow-up period. The investigators hypothesize that subjects using FeatForward will be more physically active and will achieve greater improvements in their cardio-metabolic risk (CMR) factors than a usual care control group that will not use the app over a 6-month period.
TextToMove (TTM) was a dynamic text messaging program which the investigators developed in
2012 with the goals of increasing physical activity in patients with type 2 diabetes mellitus
(T2DM), improving self-management of the disease, and lowering HbA1c levels. TTM has since
been evaluated in a PHRC-approved randomized controlled trial. In our current proposed study,
the investigators plan to convert TTM into a mobile application for smartphone use, with
increased and improved functionality and with the potential for easy translation to
additional use cases. The investigators used feedback gathered from users and observations
from the previous trial to shape the development plan for this second iteration, aptly named
"FeatForward." The FeatForward app will be hyper-personalized to users and to respond
specifically to individual users' behavior patterns so that the application feels like an
intelligent health coach partnering with users to achieve better health outcomes. What
defines FeatForward from TTM are additional features, including the incorporation of machine
learning components for the messaging algorithm, tailoring of message frequency based on
users' activity levels, integration of patient data into the electronic medical records
through the Remote Monitoring Data Repository, inputs to improve the generalizability of
feedback regarding health metrics (e.g., weight, blood glucose), as well as a community
feature to enable interactions with other similar patients and a comprehensive educational
library.
FeatForward's primary goal is to help users increase their level of physical activity.
Physical inactivity has been identified as one of the leading risk factors contributing to
the rising rates of chronic diseases. And despite being the most common cardio-metabolic risk
(CMR) factor, it also happens to be the easiest to target. Current estimates suggest that
over half (52%) of adults in the United States do not meet the recommended physical activity
levels. A number of studies to date have demonstrated the dose-response protective effect of
increasing physical activity on the development of diabetes and cardiovascular disease.
Therefore, the investigators hypothesize that FeatForward will help users to increase their
physical activity levels and also lead to improvements in cardio-metabolic risk factors
compared to usual care controls that will not use the intervention.
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