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
Verified date | August 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2019 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mass General: Charlestown Healthcare Center | Charlestown | Massachusetts |
United States | Mass General Revere HealthCare Center | Revere | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Samsung Electronics |
United States,
Kelley DE, Goodpaster BH. Effects of exercise on glucose homeostasis in Type 2 diabetes mellitus. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S495-501; discussion S528-9. Review. — View Citation
Kohl HW 3rd. Physical activity and cardiovascular disease: evidence for a dose response. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S472-83; discussion S493-4. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in the change in physical activity levels between control and intervention groups as measured by daily physical activity measured by the Gear Fit device provided to participants in both groups | 3 & 6 months | ||
Secondary | Differences in the change in body weight between control and intervention groups | 3 & 6 months | ||
Secondary | Differences in the change in HbA1c between control and intervention groups | 3 & 6 months | ||
Secondary | Differences in the change in fasting blood glucose between control and intervention groups | 3 & 6 months | ||
Secondary | Differences in the change in blood pressure between control and intervention groups | 3 & 6 months | ||
Secondary | Differences in the change in waist circumference between control and intervention groups | 3 & 6 months | ||
Secondary | Differences in the change in serum lipids between control and intervention groups | 3 & 6 months | ||
Secondary | Differences in the change in C-reactive protein between control and intervention groups | 3 & 6 months |
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