NCT01737658

Brief Summary

Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable obesity

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

November 5, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3.2 years

First QC Date

November 5, 2012

Last Update Submit

February 13, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Formal exercise intervention and cognitive dysfunction in obeses adolescents

    To measure the feasibility of recruiting extremely obese (BMI \> 99%tile corrected for age) children and adolescents into an exercise program and evaluate their physical fitness.

    1 year

Secondary Outcomes (2)

  • Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.

    1 year

  • Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.

    1 year

Study Arms (2)

Exercise Program upon enrollment

OTHER

Subject will receive exercise intervention immediately upon enrollment to study

Other: Exercise Program

Exercise Program 6 months after enrollment

OTHER

Subject will be enrolled into study and then receive exercise intervention 6 months after enrollment.

Other: Exercise Program

Interventions

Exercise ProgramOTHER

Exercise Program for Obese Adolescents

Exercise Program 6 months after enrollmentExercise Program upon enrollment

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male and female subject's ages 14 to 19 years old, extremely obese (BMI ≥ 99th percentile).
  • Clearance by pediatric cardiologist, including evaluation of V02Max.

You may not qualify if:

  • Male and female less than 14years of age or more than 19 years of age.
  • Patients with type 1 or type 2 diabetes
  • Patients with serious medical conditions.
  • Anyone who is deemed inappropriate by pediatric cardiologist during clearance evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Siham Accacha, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 29, 2012

Study Start

December 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

US(1)