- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551640
Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients
Improving Physical Activity Behavior in Patients With High Cardio-metabolic Risk Using a Multi-modal mHealth Intervention: a 2-arm Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Charlestown, Massachusetts, United States, 02129
- Mass General: Charlestown Healthcare Center
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Revere, Massachusetts, United States, 02151
- Mass General Revere HealthCare Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
|
The FeatForward mobile app will have the following features: Messaging: Educational messages tailored to user's medical conditions and motivational messages tailored to user's stage of change. Tracking: Ability to track physical activity, weight, blood pressure, blood glucose and heart rate. Community: Users in later stages of change able to encourage and motivate one another through groups. Educational Library: To provide educational tips and health information. Provider Engagement: Ability for physicians to view patient data, and send messages to patients. Monthly depression assessments: The app will prompt users to complete a monthly voluntary depression assessment. Social Support: Those using the FeatForward app will also have access to a Facebook group. |
No Intervention: Group B
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 3 & 6 months
|
3 & 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences in the change in body weight between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Differences in the change in HbA1c between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Differences in the change in fasting blood glucose between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Differences in the change in blood pressure between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Differences in the change in waist circumference between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Differences in the change in serum lipids between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Differences in the change in C-reactive protein between control and intervention groups
Time Frame: 3 & 6 months
|
3 & 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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. doi: 10.1097/00005768-200106001-00020.
- 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. doi: 10.1097/00005768-200106001-00017.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P000765
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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