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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Obesity, Health Behavior
- 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 group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Intervention 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 |
| control | Active comparator | Control 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.
BMI, Child
mean change in BMI z-score
Measured: 6 months
Secondary outcomes (2)
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
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.
- First posted20 Jan 2016 (estimated)
- Study startOct 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Nicolas M. Oreskovic, MD, MPH, Massachusetts General Hospital
- Investigators
- Nicolas M Oreskovic, MD, MPH, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Closed-loop Feedback System for Pediatric Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT02659163
- Acronym / sponsor ID
- STRIVE / R21HS024001
- Conditions
- Obesity, Health Behavior
- Keywords
- cardiometabolic risk, obesity, mHealth, health behaviors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: mHealth wristband, Behavioral: mHealth scale, Behavioral: EMA, Behavioral: mHealth app, Behavioral: Integrated closed-loop feedback systemIntervention subjects will receive feedback on their health behaviors along with clinical recommendations. |
| control | Active comparator | Behavioral: mHealth wristband, Behavioral: mHealth scale, Behavioral: EMA, Behavioral: mHealth app, Behavioral: Health Behavior FeedbackControl subjects will receive feedback on their health behaviors for self-guided care. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth wristbandAlso: sensorsA wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time | Behavioural | control, intervention |
| mHealth scaleAlso: wireless sscaleA wireless scale used by participants to measure and record daily weight. | Behavioural | control, intervention |
| EMAAlso: Sugar Sweetened Beverage AssessmentSelf-reported information on sugar sweetened beverage consumption collected via mobile messaging | Behavioural | control, intervention |
| mHealth appA mobile application that houses study data and provides two-way messaging between the study team and study participants. | Behavioural | control, intervention |
| Health Behavior FeedbackProvide feedback on patient-generated health behaviors data, along with standard of care recommendations, for self-guided | Behavioural | control |
| Integrated closed-loop feedback systemDaily feedback and weekly e-report cards on patient-generated longitudinal health behaviors along with clinical recommendations via mobile messaging | Behavioural | intervention |
Primary outcome
BMI, Child
Time frame: 6 months
mean change in BMI z-score
2 secondary outcomes
Health Behaviors Index, Child and Adult
Time frame: 6 months
BMI, Adult
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas M Oreskovic, MD, MPH principal investigator
Massachusetts General Hospital
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.