NCT02960386

Brief Summary

The iTrackFitness study aims to test the "engagement engine" that was developed from activity tracker and survey data gathered during phase I of the study. For the current phase the "engagement engine" will support successful and sustained engagement with health trackers thereby increasing physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

September 12, 2016

Last Update Submit

February 22, 2021

Conditions

OverweightObese

Outcome Measures

Primary Outcomes (1)

  • Engagement level with the tracker

    To assess the level of participant's engagement with physical activity tracker

    24 weeks

Secondary Outcomes (3)

  • Change in Physical Activity

    24 weeks

  • Change in Self-efficacy scale for Physical Activity

    24 weeks

  • Change in Barriers to Being Active Questionnaire

    24 weeks

Study Arms (1)

Machine Learning Algorithm

OTHER

Single group participants that will use the algorithm to be engaged in using their fitness tracker.

Other: Machine Learning Algorithm

Interventions

Machine Learning AlgorithmOTHER

The algorithm will help participants improve physical activity by sustaining long term engagement with their fitness tracker.

Also known as: Engagement Engine
Machine Learning Algorithm

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18+ years of age
  • Body Mass Index (BMI) 25-40 kg/m2
  • Interest in using a fitness tracker for the duration of the study (24 weeks)
  • Possess a smartphone, tablet or computer with the FiBit app
  • Consent to undergo a phone interview with a member of the study staff
  • Ability to receive text messages on their phone
  • Fluency in English

You may not qualify if:

  • Self-reported eating disorder and/or other psychiatric disorders
  • Pregnancy or plans to get pregnant within 6 months of enrollment
  • Disability, dementia or neurological deficits, and other medical or surgical conditions preventing participants from engaging in physical activity
  • Serious co-morbid conditions (e.g., terminal cancers, end-stage renal disease) that preclude safe participation in moderate levels of physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Machine Learning Algorithms

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Kamal Jethwani, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist

Study Record Dates

First Submitted

September 12, 2016

First Posted

November 9, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2018

Study Completion

July 1, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

US(1)