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

Mass General Brigham

Status

Completed

Conditions

Hypertension

Prehypertension

Prediabetic State

Obesity

Diabetes Mellitus, Type 2

Treatments

Other: FeatForward App (on study smartphone)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02551640

2015P000765

Details and patient eligibility

About

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.

Full description

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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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