Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients

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.

Inclusion Criteria:

- Age ≥18 years old

- Diagnosis of any of the following: pre-diabetes, Type 2 Diabetes Mellitus (T2DM),
pre-hypertension, hypertension, and/or obesity (Body Mass Index (BMI) ≥ 30 kg/m2).

- T2DM: Glycated Hemoglobin (HbA1c) >7.0%

- Hypertension: Blood Pressure (BP) of 140/90 mmHg

- Pre-diabetes: HbA1c >5.7% and BMI ≥ 25 kg/m2

- Pre-hypertension: BP of 130/90 mmHg and family history of high BP

- Willingness to attend all 3 study visits

- Ability to read and speak fluent English

- Physical independence (i.e., ability to walk without assistance)

- Ability to consent for oneself

- Willingness to switch to a provided Samsung smartphone and appropriate phone plan to
use as a primary phone for the 6-month study duration

- Willingness to wear a Samsung smartwatch during all hours excluding sleep for the
duration of the study

Exclusion Criteria:

- Participants with severe depression assessed by scoring ≥20 on the PHQ-8 screening
questionnaire for depression

- Self-reported eating disorder and/or other psychiatric disorders

- Current or recent participation (within 3 months) in a weight loss program

- Prior or planned bariatric surgery procedure

- Use of medications known to cause significant (≥ 5%) long-term changes in body weight
or BP

- Pregnancy or plans to get pregnant within 6 months of enrollment

- Disability, dementia or neurological deficits, and other medical or surgical
conditions preventing participants from engaging in self-care

- Serious co-morbid conditions (e.g., terminal cancers, end-stage renal disease) that
preclude safe participation in moderate levels of physical activity, under discretion
of the participants' primary care provider