NCT02659163

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for early_phase_1 obesity

Timeline
Completed

Started Oct 2017

Status
unknown

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

First Submitted

Initial submission to the registry

January 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

January 12, 2016

Last Update Submit

August 31, 2017

Conditions

ObesityHealth Behavior

Keywords

cardiometabolic riskobesitymHealthhealth behaviors

Outcome Measures

Primary Outcomes (1)

  • BMI, Child

    mean change in BMI z-score

    6 months

Secondary Outcomes (2)

  • Health Behaviors Index, Child and Adult

    6 months

  • BMI, Adult

    6 months

Study Arms (2)

intervention

EXPERIMENTAL

Intervention subjects will receive feedback on their health behaviors along with clinical recommendations.

Behavioral: mHealth wristbandBehavioral: mHealth scaleBehavioral: EMABehavioral: mHealth appBehavioral: Integrated closed-loop feedback system

control

ACTIVE COMPARATOR

Control subjects will receive feedback on their health behaviors for self-guided care.

Behavioral: mHealth wristbandBehavioral: mHealth scaleBehavioral: EMABehavioral: mHealth appBehavioral: Health Behavior Feedback

Interventions

mHealth wristbandBEHAVIORAL

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

Also known as: sensors
controlintervention
mHealth scaleBEHAVIORAL

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

Also known as: wireless sscale
controlintervention
EMABEHAVIORAL

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

Also known as: Sugar Sweetened Beverage Assessment
controlintervention
mHealth appBEHAVIORAL

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

controlintervention
Health Behavior FeedbackBEHAVIORAL

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

control
Integrated closed-loop feedback systemBEHAVIORAL

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

intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nicolas M Oreskovic, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas M Oreskovic, MD, MPH

CONTACT

617.726.0593noreskovic@mgh.harvard.edu

John D Knutsen, PhD

CONTACT

617.726.6721jknutsen@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 20, 2016

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

September 1, 2017

Record last verified: 2017-08