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ObesityEarly Phase 1STRIVENCT02659163

An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease

A Early Phase 1 study testing mHealth wristband, mHealth scale and EMA in people with Obesity and Health Behavior, run by Massachusetts General Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Health Behavior
What is being tested?
mHealth wristband, mHealth scale and EMA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
Oct 2017to Oct 2018
Phase
Early Phase 1
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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • n/a

Trial locations and contacts

No sites are listed yet.

Nicolas M Oreskovic, MD, MPH contact

617.726.0593

noreskovic@mgh.harvard.edu

John D Knutsen, PhD contact

617.726.6721

jknutsen@mgh.harvard.edu

About this study

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.

Read the detailed 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.

Being tested
mHealth wristband, mHealth scale, EMA, mHealth app, Health Behavior Feedback
Keywords
cardiometabolic risk, obesity, mHealth, health behaviors
Medical subject headings
Obesity, Health Behavior

What participants receive

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

  • mHealth wristbandBehavioural

    Also called sensors

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

  • mHealth scaleBehavioural

    Also called wireless sscale

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

  • EMABehavioural

    Also called Sugar Sweetened Beverage Assessment

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

  • mHealth appBehavioural

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

  • Health Behavior FeedbackBehavioural

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

  • Integrated closed-loop feedback systemBehavioural

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

Study groups in NCT02659163
Study groupRoleWhat they receive
interventionExperimentalIntervention subjects will receive feedback on their health behaviors along with clinical recommendations.
Receives: Behavioral: mHealth wristband; Behavioral: mHealth scale; Behavioral: EMA; Behavioral: mHealth app; Behavioral: Integrated closed-loop feedback system
controlActive comparatorControl subjects will receive feedback on their health behaviors for self-guided care.
Receives: Behavioral: mHealth wristband; Behavioral: mHealth scale; Behavioral: EMA; Behavioral: mHealth app; Behavioral: Health Behavior Feedback

What is being measured

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

  1. BMI, Child

    mean change in BMI z-score

    Measured: 6 months

Secondary outcomes (2)
  1. Health Behaviors Index, Child and Adult

    Cardiometabolic risk will be reported as an index score, a continuous variable calculated as the sum of Z-scores of mean daily moderate-to-vigorous physical activity (minutes), mean daily sleep (minutes), mean daily screen time (minutes), and mean weekly sugar sweetened beverage intake.

    Measured: 6 months

  2. BMI, Adult

    mean change in BMI z-score

    Measured: 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 posted20 Jan 2016 (estimated)
  2. Study startOct 2017 (estimated)
  3. Primary completionOct 2018 (estimated)
  4. Study completionOct 2018 (estimated)

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
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659163
Sponsor's protocol ID
R21HS024001
Acronym
STRIVE
Status last verified
Aug 2017
First submitted
12 Jan 2016
Last updated
1 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing mHealth wristband, mHealth scale and EMA in people with Obesity and Health Behavior, run by Massachusetts General Hospital.

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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Nicolas M Oreskovic, MD, MPH (617.726.0593, noreskovic@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI, Child (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2017; AzTrials last refreshed its copy on 1 Nov 2026.

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