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Diabetes Mellitus, Type 2NCT02551640

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

A study testing FeatForward App (on study smartphone) in people with Diabetes Mellitus, Type 2 and Prediabetic State, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FeatForward App (on study smartphone)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesUnited States
Study dates
Sep 2015to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mass General: Charlestown Healthcare Center

    Charlestown, Massachusetts, 02129

  • Mass General Revere HealthCare Center

    Revere, Massachusetts, 02151

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
FeatForward App (on study smartphone)
Medical subject headings
Diabetes Mellitus, Type 2, Prediabetic State, Hypertension, Prehypertension, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FeatForward App (on study smartphone)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.

Study groups in NCT02551640
Study groupRoleWhat they receive
Group AExperimental* Receive a Samsung smartphone * Receive the FeatForward app * Receive a Samsung smartwatch * Continue to receive medical care as usual
Receives: Other: FeatForward App (on study smartphone)
Group BNo intervention* Receive a Samsung smartphone * Receive a Samsung smartwatch * Continue to receive medical care as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 & 6 months

Secondary outcomes (7)

  1. Differences in the change in body weight between control and intervention groups

    Measured: 3 & 6 months

  2. Differences in the change in HbA1c between control and intervention groups

    Measured: 3 & 6 months

  3. Differences in the change in fasting blood glucose between control and intervention groups

    Measured: 3 & 6 months

  4. Differences in the change in blood pressure between control and intervention groups

    Measured: 3 & 6 months

  5. Differences in the change in waist circumference between control and intervention groups

    Measured: 3 & 6 months

  6. Differences in the change in serum lipids between control and intervention groups

    Measured: 3 & 6 months

  7. Differences in the change in C-reactive protein between control and intervention groups

    Measured: 3 & 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2018
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551640
Sponsor's protocol ID
2015P000765
Status last verified
Aug 2020
First submitted
10 Sep 2015
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 11427773

  • 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.

    PubMed 11427776

Questions about this trial

What is this clinical trial studying?

A study testing FeatForward App (on study smartphone) in people with Diabetes Mellitus, Type 2 and Prediabetic State, run by Massachusetts General Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02551640, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

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