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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01938950
Acronym
RCT:RCT
Enrollment
118
Registered
2013-09-10
Start date
2013-10-31
Completion date
2017-06-21
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Brief 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.

Interventions

OTHERAerobic Exercise
OTHERResistance Exercise

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Insulin sensitivity6 months

Secondary

MeasureTime frameDescription
Total and regional body composition6 monthsTotal fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass
Cardiovascular disease risk factors6 monthsCarotid intima-media thickness, arterial stiffness, endothelial dysfunction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026