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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Prediabetic State, Hypertension, Prehypertension, Obesity

In brief

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.

Key facts

Study ID

NCT02551640

Run by

Massachusetts General Hospital

People needed

300

Starts

2015-09-01

Expected to finish

2019-12-01

Last updated by the study team

2020-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mass General: Charlestown Healthcare Center — Charlestown, Massachusetts, United States
• Mass General Revere HealthCare Center — Revere, Massachusetts, United States

Full record on ClinicalTrials.gov

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