An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease

Summary

The high prevalence and burden of cardiometabolic disease underlie the urgent need to identify novel approaches to managing and preventing cardiometabolic disease and risk. This project will test an innovative use of mobile health technology to implement a closed-loop feedback system that collects objective patient-generated data and provides clinical recommendations to modify contributing health behaviors. In addition to improving care for cardiometabolic disease, the tools and methods developed by this study for collecting patient data and providing clinical feedback could also easily be adapted and applied to a range of other health conditions, and are thus highly relevant to public health.

Conditions

• Obesity
• Health Behavior

Interventions

BEHAVIORAL

mHealth wristband

A wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time

BEHAVIORAL

mHealth scale

A wireless scale used by participants to measure and record daily weight.

BEHAVIORAL

EMA

Self-reported information on sugar sweetened beverage consumption collected via mobile messaging

BEHAVIORAL

mHealth app

A mobile application that houses study data and provides two-way messaging between the study team and study participants.

BEHAVIORAL

Health Behavior Feedback

Provide feedback on patient-generated health behaviors data, along with standard of care recommendations, for self-guided

BEHAVIORAL

Integrated closed-loop feedback system

Daily feedback and weekly e-report cards on patient-generated longitudinal health behaviors along with clinical recommendations via mobile messaging

Sponsors & Collaborators

• Massachusetts Institute of Technology

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Nicolas M Oreskovic, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-31

Primary Completion

2018-10-31

Completion

2018-10-31