An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease (STRIVE)

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Mass General Brigham

Status and phase

Unknown
Early Phase 1

Conditions

Obesity
Health Behavior

Treatments

Behavioral: mHealth app
Behavioral: Integrated closed-loop feedback system
Behavioral: mHealth scale
Behavioral: mHealth wristband
Behavioral: Health Behavior Feedback
Behavioral: EMA

Study type

Interventional

Funder types

Other

Identifiers

NCT02659163
R21HS024001

Details and patient eligibility

About

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.

Full description

Cardiometabolic disease - a clustering of medical conditions and risk factors which includes obesity, diabetes, impaired liver function, and an increased risk in children for adult-onset cardiovascular disease - represents a major population-wide health burden in the United States. Management of cardiometabolic disease also imposes a substantial financial burden on the economy and ties up significant healthcare resources. It is well-known that many of the lifestyle and health behaviors that contribute to cardiometabolic disease are difficult to modify once established, and childhood represents an opportune time for promoting healthy behaviors. Patient-centered outcomes research (PCOR) has identified certain health behaviors as important and actionable in modifying cardiometabolic risk, namely weight management, physical activity, screen-time, sleep, and consumption of sugar-sweetened beverages. Mobile health technology (mHealth) could be used to monitor and counsel on common health behaviors associated with cardiometabolic risk, which may facilitate the inclusion of PCOR evidence on cardiometabolic disease into clinical practice. The overall goal of this research is to use mHealth technology to accelerate the uptake of PCOR findings on treatment of cardiometabolic disease. To achieve our goal, this study will develop a novel set of mHealth tools capable of collecting health behavior information and determine to what extent providing clinical feedback on these health behaviors improves obesity and health behaviors among children ages 6-12 year and their families. In this study we will develop, implement, and test the comparative clinical effectiveness of a closed-loop feedback system for collecting patient data and providing recommendations. The specific aims of this study are: 1) to develop an integrated closed-loop feedback system that incorporates longitudinal mHealth data in managing cardiometabolic disease among at-risk families, and 2) to determine the extent to which an integrated closed-loop system that provides feedback on objective patient-generated data improves cardiometabolic risk, as measured by changes in body mass index and health behaviors including, physical activity, screen-time, sleep, and sugar-sweetened beverage consumption. This research will develop novel mHealth tools and approaches that will allow healthcare providers and patients to better understand disease risk and improve disease management by collecting patient data 1) repeatedly over time, 2) simultaneously, and 3) objectively. This study is innovative because it will use mHealth tools to simultaneously collect longitudinal data on multiple health behaviors known to be associated with cardiometabolic risk, and it will offer a new approach to implementing and disseminating PCOR findings via a novel closed-loop feedback system. The high prevalence of cardiometabolic disease makes this innovative closed-loop system very relevant to public health. The mHealth 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.

Enrollment

68 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • ages 6-12 years
  • body mass index categorized as overweight or obese
  • followed for obesity care
  • an adult household family member with one or more elevated cardiometabolic risk, as defined by established or documented increased risk of cardiometabolic disease (overweight, obesity, hypertension, coronary artery disease, diabetes or glucose intolerance, dyslipidemia, non-alcoholic fatty liver disease, cerebrovascular disease)
  • participating parent must own Android Smartphone
  • Wi-Fi access at home
  • speak and read English

Exclusion criteria

  • n/a

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 2 patient groups

intervention
Experimental group
Description:
Intervention subjects will receive feedback on their health behaviors along with clinical recommendations.
Treatment:
Behavioral: EMA
Behavioral: mHealth wristband
Behavioral: mHealth scale
Behavioral: Integrated closed-loop feedback system
Behavioral: mHealth app
control
Active Comparator group
Description:
Control subjects will receive feedback on their health behaviors for self-guided care.
Treatment:
Behavioral: EMA
Behavioral: Health Behavior Feedback
Behavioral: mHealth wristband
Behavioral: mHealth scale
Behavioral: mHealth app

Trial contacts and locations

0

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Central trial contact

Nicolas M Oreskovic, MD, MPH; John D Knutsen, PhD

Data sourced from clinicaltrials.gov

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