Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)

Childhood Obesity Clinical Trial

— RCT:RCT  

Official title:

Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01938950
• Other study ID #: PRO12080401
• Secondary ID: 1R01HL114857-01A
• Status: Terminated
• Phase: N/A
• First received: September 5, 2013
• Last updated: June 27, 2017
• Start date: October 2013
• Est. completion date: June 21, 2017

Study information

• Verified date: June 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current epidemic rate of childhood obesity is a leading health concern as overweight/obese youth may suffer from comorbid conditions, once considered exclusive to adults. It has been suggested that physical inactivity is a major determinant of obesity and obesity-related health risk in children and adolescents. Recent studies in adults report that the combination of aerobic and resistance exercise is a better strategy than aerobic or resistance exercise alone for reducing risk factors for type 2 diabetes. Currently, the most effective exercise modality for concurrent reductions of adiposity, in particular abdominal fat, and risk factors for type 2 diabetes and cardiovascular disease (CVD) is unknown in adolescents. Therefore, we will employ a randomized trial to examine the effects of a long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and skeletal muscle, and 3) traditional and non-traditional risk factors/markers for CVD in overweight boys and girls. We will recruit 168 sedentary overweight (BMI >85th percentile) adolescent boys and girls aged 12-17 years old and randomly assign them to one of three 6-month intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2) resistance exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week) group. A weight maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will be prescribed and monitored for all groups, so that any changes in energy balance will be induced by exercise intervention alone (e.g., no calorie restriction). We believe that this proposed application will have a significant implication that is directly relevant for one in three American adolescents who are at increased risk of developing obesity-related co-morbidities.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 118
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

Age 12-17 years

• BMI percentile for age and sex >-85% percentile and BMI <40 kg/m2

• No structured physical activity in the past 3 months prior to the study (not including school physical education classes)

• No significant weight changes (>2-3 kg/m2) in the past 3 months prior to the study

Exclusion Criteria:

• Endocrine disorders (e.g., polycystic ovary syndrome, diabetes)

• Syndromic obesity

• Positive pregnancy test

• Use of chronic medications which influence glucose metabolism and body composition

• Chronic medical/psychiatric conditions preventing the ability to participate in the study.

• Anemia

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Other:
• Aerobic Exercise

• Resistance Exercise

• Aerobic and Resistance Exercise

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		6 months
Secondary	Total and regional body composition	Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass	6 months
Secondary	Cardiovascular disease risk factors	Carotid intima-media thickness, arterial stiffness, endothelial dysfunction	6 months