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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

mActive: A Blinded, Randomized mHealth Activity Trial

NCT01917812

Physical Activity

COMPLETED NA

A Micro-randomized Trial of HeartSteps, an mHealth Intervention for Increasing Physical Activity

NCT03225521

Physical Activity

COMPLETED NA

An mHealth Mobile Application Supporting Maintenance of Physical Activity Among Men and Women With High Blood Pressure

NCT03937674

Physical Activity

COMPLETED NA

A Smartphone-based Intervention to Promote an Active Lifestyle in Low Educated Working Young Adults

NCT02948803

Physical Activity

COMPLETED NA

Using Mobile Technology to Promote Physical Activity

NCT02265432

Physical Activity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Prediabetic State Hypertension Prehypertension Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

* Receive a Samsung smartphone
* Receive the FeatForward app
* Receive a Samsung smartwatch
* Continue to receive medical care as usual

Group Type EXPERIMENTAL

FeatForward App (on study smartphone)

Intervention Type OTHER

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.

Group B

* Receive a Samsung smartphone
* Receive a Samsung smartwatch
* Continue to receive medical care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FeatForward App (on study smartphone)

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No