NCT03004378

Brief Summary

This study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. The investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 23, 2020

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

December 20, 2016

Last Update Submit

January 21, 2020

Conditions

Adolescent Obesity

Keywords

obesityadolescenttracking devicefitbit

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.

    We set a study attrition rate of participants at ≤50% as the feasibility measure for the study.

    18 weeks

Secondary Outcomes (3)

  • Body mass index (BMI) (kg/m2)

    Change from 0 to 18 weeks

  • Weight (kg)

    Change from 0 to 18 weeks

  • Change in obesity related biomarkers

    Change from 0 to 18 weeks

Study Arms (2)

Control

NO INTERVENTION

Participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.

Intervention

EXPERIMENTAL

Fitbit (activity tracker) + participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit.

Behavioral: Activity Tracker

Interventions

Activity TrackerBEHAVIORAL

Fitbit Alta

Intervention

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition

You may not qualify if:

  • Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • Bowen-Jallow K, Nunez-Lopez O, Wright A, Fuchs E, Ahn M, Lyons E, Jupiter D, Berry L, Suman O, Radhakrishnan RS, Glaser AM, Thompson DI. Wearable Activity Tracking Device Use in an Adolescent Weight Management Clinic: A Randomized Controlled Pilot Trial. J Obes. 2021 Jan 7;2021:7625034. doi: 10.1155/2021/7625034. eCollection 2021.

    PMID: 33505717DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Kanika K Bowen-Jallow, MD, MMS

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 28, 2016

Study Start

January 1, 2018

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

January 23, 2020

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

The investigators will provide all data, regardless of publication, collected as part of this project. All external investigators must submit a written request identifying their research question(s) and specifying the data they are requesting. The request must include a data security plan and explanation of how the data will be stored and who will have access.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will only be available upon request
Access Criteria
The request must include a data security plan and explanation of how the data will be stored and who will have access.

Locations

US(1)