Childhood ObesityRCT:RCTNCT01938950
Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)
A study testing Aerobic Exercise, Resistance Exercise and Aerobic and Resistance Exercise in people with Childhood Obesity, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Aerobic Exercise, Resistance Exercise and Aerobic and Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 21 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
About this study
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.
- Conditions
- Childhood Obesity
- Being tested
- Aerobic Exercise, Resistance Exercise, Aerobic and Resistance Exercise
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Resistance ExerciseOther
Aerobic and Resistance ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Active comparator | Participants will perform aerobic exercise using treadmills and/or ellipticals at 40-65% of VO2peak, three times per week, for 60 minutes/session. Receives: Other: Aerobic Exercise |
| Resistance Exercise | Active comparator | Participants will perform 2 sets (8-12 repetitions per set) of 8 exercises to the point of failure using weight stack equipment, three times per week, for 60 minutes/session. 2 sets of push-ups and sit-ups will also be performed. Receives: Other: Resistance Exercise |
| Aerobic and Resistance Exercise | Active comparator | Participants will perform aerobic exercise using treadmills and/or ellipticals for 30 min at 40-65% of VO2peak and thereafter, perform 1 set of each of the above 10 resistance exercise for 30 min. Receives: Other: Aerobic and Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: 6 months
Secondary outcomes (2)
Total and regional body composition
Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass
Measured: 6 months
Cardiovascular disease risk factors
Carotid intima-media thickness, arterial stiffness, endothelial dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Why it stopped: PI is leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, SoJung Lee, University of Pittsburgh
- Investigators
- SoJung Lee, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938950
- Sponsor's protocol ID
- PRO12080401
- Other IDs
- 1R01HL114857-01A1
- Acronym
- RCT:RCT
- Status last verified
- Jun 2017
- First submitted
- 5 Sep 2013
- Last updated
- 28 Jun 2017
- Results posted
- No
Publications
Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.
PubMed 33739874Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.
PubMed 32674604Lee S, Libman I, Hughan KS, Kuk JL, Barinas-Mitchell E, Chung H, Arslanian S. Effects of exercise modality on body composition and cardiovascular disease risk factors in adolescents with obesity: a randomized clinical trial. Appl Physiol Nutr Metab. 2020 Dec;45(12):1377-1386. doi: 10.1139/apnm-2019-0993.
PubMed 32674587Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.
PubMed 31235380Lee S, Libman I, Hughan K, Kuk JL, Jeong JH, Zhang D, Arslanian S. Effects of Exercise Modality on Insulin Resistance and Ectopic Fat in Adolescents with Overweight and Obesity: A Randomized Clinical Trial. J Pediatr. 2019 Mar;206:91-98.e1. doi: 10.1016/j.jpeds.2018.10.059. Epub 2018 Dec 13.
PubMed 30554789
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)
- ClinicalTrials.gov ID
- NCT01938950
- Acronym / sponsor ID
- RCT:RCT / PRO12080401
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is leaving the institution
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2013
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Active comparator | Other: Aerobic ExerciseParticipants will perform aerobic exercise using treadmills and/or ellipticals at 40-65% of VO2peak, three times per week, for 60 minutes/session. |
| Resistance Exercise | Active comparator | Other: Resistance ExerciseParticipants will perform 2 sets (8-12 repetitions per set) of 8 exercises to the point of failure using weight stack equipment, three times per week, for 60 minutes/session. 2 sets of push-ups and sit-ups will also be performed. |
| Aerobic and Resistance Exercise | Active comparator | Other: Aerobic and Resistance ExerciseParticipants will perform aerobic exercise using treadmills and/or ellipticals for 30 min at 40-65% of VO2peak and thereafter, perform 1 set of each of the above 10 resistance exercise for 30 min. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise | Other | Aerobic Exercise |
| Resistance Exercise | Other | Resistance Exercise |
| Aerobic and Resistance Exercise | Other | Aerobic and Resistance Exercise |
Primary outcome
Insulin sensitivity
Time frame: 6 months
2 secondary outcomes
Total and regional body composition
Time frame: 6 months
Cardiovascular disease risk factors
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI is leaving the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 33739874Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.
- Derived from this study: PubMed 32674604Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.
- Derived from this study: PubMed 32674587Lee S, Libman I, Hughan KS, Kuk JL, Barinas-Mitchell E, Chung H, Arslanian S. Effects of exercise modality on body composition and cardiovascular disease risk factors in adolescents with obesity: a randomized clinical trial. Appl Physiol Nutr Metab. 2020 Dec;45(12):1377-1386. doi: 10.1139/apnm-2019-0993.
- Derived from this study: PubMed 31235380Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.
- Derived from this study: PubMed 30554789Lee S, Libman I, Hughan K, Kuk JL, Jeong JH, Zhang D, Arslanian S. Effects of Exercise Modality on Insulin Resistance and Ectopic Fat in Adolescents with Overweight and Obesity: A Randomized Clinical Trial. J Pediatr. 2019 Mar;206:91-98.e1. doi: 10.1016/j.jpeds.2018.10.059. Epub 2018 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SoJung Lee, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise, Resistance Exercise and Aerobic and Resistance Exercise in people with Childhood Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI is leaving the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01938950, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.