NCT04312919

Brief Summary

This is a randomized prospective study to evaluate the effectiveness of a family-based intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18 years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic multidisciplinary "Be Well" pediatric obesity clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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

February 3, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

March 13, 2020

Last Update Submit

January 31, 2024

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    6 minute walk distance

    Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)

Secondary Outcomes (3)

  • Weight

    Change from Baseline weight through study completion (up to 33 weeks)

  • Fitbit Data

    Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps

  • Height

    Change from Baseline height through study completion (up to 33 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

3 in-person visit group

Behavioral: Family Based Activity Intervention

Control/Crossover Group

ACTIVE COMPARATOR

5 in-person visit group

Behavioral: Family Based Activity Intervention

Interventions

Family Based Activity InterventionBEHAVIORAL

Providing youth and their families with access to the knowledge and resources to increase their physical activity will allow them to lead more healthy lifestyles will provide them with the foundation for a healthier life, and future ahead.

Control/Crossover GroupIntervention Group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Be Well patient
  • Age 8\*-18 years
  • BMI \> 95%ile
  • English speaking

You may not qualify if:

  • Uncontrolled asthma
  • Orthopedic or other medical issue limiting mobility
  • Participant has worn an activity-monitor in the past 6 months (ok if parents wear)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Staff Physician

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 18, 2020

Study Start

February 3, 2020

Primary Completion

September 27, 2021

Study Completion

September 27, 2021

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

US(1)