NCT02551640

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

September 10, 2015

Last Update Submit

August 29, 2020

Conditions

Diabetes Mellitus, Type 2Prediabetic StateHypertensionPrehypertensionObesity

Outcome Measures

Primary Outcomes (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

    3 & 6 months

Secondary Outcomes (7)

  • Differences in the change in body weight between control and intervention groups

    3 & 6 months

  • Differences in the change in HbA1c between control and intervention groups

    3 & 6 months

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

    3 & 6 months

  • Differences in the change in blood pressure between control and intervention groups

    3 & 6 months

  • Differences in the change in waist circumference between control and intervention groups

    3 & 6 months

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: FeatForward App (on study smartphone)

Group B

NO INTERVENTION

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

Interventions

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.

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mass General: Charlestown Healthcare Center

Charlestown, Massachusetts, 02129, United States

Location

Mass General Revere HealthCare Center

Revere, Massachusetts, 02151, United States

Location

Related Publications (2)

  • 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.

    PMID: 11427773BACKGROUND

  • 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.

    PMID: 11427776BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateHypertensionPrehypertensionObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kamal Jethwani, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2018

Study Completion

December 1, 2019

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

US(2)