NCT03096873

Brief Summary

The purpose of the study was to observe therapeutic effects of combined resistance and aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese adolescent girls (14±1 years) participated in this study. The participants were randomly separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise group performed 12 weeks of CRAE.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable obesity

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

Study Start

First participant enrolled

March 3, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2011

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2011

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

August 19, 2019

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

March 17, 2017

Results QC Date

March 25, 2019

Last Update Submit

October 30, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (11)

  • Height in Meters

    Height was measured before and after 12 weeks.

    12 weeks

  • Weight in Kilograms

    Weight was measured before and after 12 weeks.

    12 weeks

  • BMI in Weight (Kilograms)/Height (Meters)^2

    BMI was calculated with weight and height before and after 12 weeks.

    12 weeks

  • Body Fat in Percents

    Body fat was measured before and after 12 weeks.

    12 weeks

  • Lean Body Mass in Percents

    Lean body mass was measured before and after 12 weeks.

    12 weeks

  • Waist Circumference in Centimeters

    Waist circumference was measured before and after 12 weeks.

    12 weeks

  • Glucose Levels in Millimole Per Liter

    Glucose levels were measured before and after 12 weeks.

    12 weeks

  • Insulin Levels in Micro Unit Per Milliliter

    Insulin levels were measured before and after 12 weeks.

    12 weeks

  • Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Homeostasis model assessment of Insulin Resistance (HOMA-IR) was calculated before and after 12 weeks

    12 weeks

  • Leptin Levels in Nano Grams Per Milliliter

    Leptin levels were measured before and after 12 weeks.

    12 weeks

  • Adiponectin Levels in Micro Grams Per Milliliter

    Adiponectin levels were measured before and after the training.

    12 weeks

Secondary Outcomes (5)

  • Volume of Maximal Oxygen Consumption (VO2max)

    12 weeks

  • Arterial Stiffness

    12 weeks

  • Systolic Blood Pressure

    12 weeks

  • Diastolic Blood Pressure

    12 weeks

  • Maximal Heart Rate

    12 weeks

Study Arms (2)

No Exercise (CON)

NO INTERVENTION

Twenty obese adolescent girls. This arm did not perform any exercise training for 12 weeks. Caloric intake: 1921.7 kcal/day

Exercise (EX)

EXPERIMENTAL

Twenty obese adolescent girls. This arm performed combined exercise training 5 times a week for 12 weeks. Caloric intake: 1921.7 kcal/day

Behavioral: Combined Exercise Training

Interventions

Combined Exercise TrainingBEHAVIORAL

The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks.

Exercise (EX)

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Obese with Hyperinsulinemia
  • Obese with Abdominal obesity

You may not qualify if:

  • Hypertension
  • Pregnancy
  • Chronic diseases
  • Weight loss diet within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Song-Young Park
Organization
The University of Nebraska at Omaha
song-youngpark@unomaha.edu
402-554-3374

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 30, 2017

Study Start

March 3, 2011

Primary Completion

June 3, 2011

Study Completion

June 5, 2011

Last Updated

November 3, 2020

Results First Posted

August 19, 2019

Record last verified: 2020-10