ObesityPhase 2NCT00108901
The Medical College of Georgia PLAY Project: Exercise Dose and Insulin Sensitivity in Obese Children
A Phase 2 study testing Aerobic exercise program in people with Obesity and Type 2 Diabetes Prevention, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Prevention, Executive Function (Cognition)
- What is being tested?
- Aerobic exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jan 2007
- Phase
- Phase 2
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight, sedentary children
- Black or white race
- Attending specific schools in Augusta, GA area from which this study is recruiting
Who cannot join
- Unable to participate in testing or vigorous exercise program
- Diabetes
- Taking medication that would affect study results
- Sibling enrolled in project
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Prevention Institute, Medical College of Georgia
Augusta, Georgia, 30912
About this study
Official title: Exercise Dose and Insulin Sensitivity in Obese Children
The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren.
The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases.
An ancillary study examined effects on cognition and achievement.
Read the detailed description
The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on insulin response to the oral glucose tolerance test, body composition, fitness, lipid profile, inflammation and other metabolic syndrome components in overweight elementary schoolchildren.
Blinded psychological assessments of cognition and achievement were obtained.
- Being tested
- Aerobic exercise program
- Keywords
- prevention, children, diabetes, overweight, obesity, metabolic syndrome, exercise, insulin resistance, female, male, black, African-American, white, Caucasian, cognition, executive function
- Medical subject headings
- Obesity, Diabetes Mellitus, Overweight, Metabolic Syndrome, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise programBehavioural
Vigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of >150 bpm average HR each day and attending at least 80% of sessions (4 days/week).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Children were not provided with an after-school exercise intervention. They were free to do their usual activities. Families were offered a monthly healthy lifestyle class. |
| Low Dose | Experimental | This group was assigned to receive a 20 min/day aerobic exercise program offered 5 days/week after school. Families were offered a monthly healthy lifestyle class. Receives: Behavioral: Aerobic exercise program |
| High dose | Experimental | This group was assigned to receive a 40 min/day aerobic exercise program offered 5 days/week after school. Families were offered a monthly healthy lifestyle class. Receives: Behavioral: Aerobic exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin area under the curve (oral glucose tolerance test)
Measured: 10-15 weeks
Body composition (% body fat, visceral fat)
Measured: 10-15 weeks
Aerobic fitness
Measured: 10-15 weeks
Cognition (Executive function)
Measured: 10-15 weeks
Secondary outcomes (5)
Glucose (oral glucose tolerance test)
Measured: 10-15 weeks
Lipid profile
Measured: 10-15 weeks
Inflammation (C-reactive protein, fibrinogen)
Measured: 10-15 weeks
Blood pressure
Measured: 10-15 weeks
Academic achievement
Measured: 10-15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Catherine L Davis, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108901
- Sponsor's protocol ID
- 60692 (completed)
- Other IDs
- R01DK060692, R01DK070922
- Status last verified
- Dec 2014
- First submitted
- 20 Apr 2005
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis CL, Tkacz J, Gregoski M, Boyle CA, Lovrekovic G. Aerobic exercise and snoring in overweight children: a randomized controlled trial. Obesity (Silver Spring). 2006 Nov;14(11):1985-91. doi: 10.1038/oby.2006.232.
PubMed 17135615Davis CL, Tomporowski PD, Boyle CA, Waller JL, Miller PH, Naglieri JA, Gregoski M. Effects of aerobic exercise on overweight children's cognitive functioning: a randomized controlled trial. Res Q Exerc Sport. 2007 Dec;78(5):510-9. doi: 10.1080/02701367.2007.10599450.
PubMed 18274222Tomporowski PD, Davis CL, Miller PH, Naglieri JA. Exercise and Children's Intelligence, Cognition, and Academic Achievement. Educ Psychol Rev. 2008 Jun 1;20(2):111-131. doi: 10.1007/s10648-007-9057-0.
PubMed 19777141Davis CL, Pollock NK, Waller JL, Allison JD, Dennis BA, Bassali R, Melendez A, Boyle CA, Gower BA. Exercise dose and diabetes risk in overweight and obese children: a randomized controlled trial. JAMA. 2012 Sep 19;308(11):1103-12. doi: 10.1001/2012.jama.10762.
PubMed 22990269
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Dose and Insulin Sensitivity in Obese Children
- ClinicalTrials.gov ID
- NCT00108901
- Acronym / sponsor ID
- 60692 (completed)
- Keywords
- prevention, children, diabetes, overweight, obesity, metabolic syndrome, exercise, insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 21 Apr 2005 (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 study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren.
The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases.
An ancillary study examined effects on cognition and achievement.
Detailed description
The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on insulin response to the oral glucose tolerance test, body composition, fitness, lipid profile, inflammation and other metabolic syndrome components in overweight elementary schoolchildren.
Blinded psychological assessments of cognition and achievement were obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Children were not provided with an after-school exercise intervention. They were free to do their usual activities. Families were offered a monthly healthy lifestyle class. |
| Low Dose | Experimental | Behavioral: Aerobic exercise programThis group was assigned to receive a 20 min/day aerobic exercise program offered 5 days/week after school. Families were offered a monthly healthy lifestyle class. |
| High dose | Experimental | Behavioral: Aerobic exercise programThis group was assigned to receive a 40 min/day aerobic exercise program offered 5 days/week after school. Families were offered a monthly healthy lifestyle class. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Overweight, sedentary children
- Black or white race
- Attending specific schools in Augusta, GA area from which this study is recruiting
Key exclusion criteria (4 listed)
- Unable to participate in testing or vigorous exercise program
- Diabetes
- Taking medication that would affect study results
- Sibling enrolled in project
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 programVigorous intermittent physical activity in group format conducted in research gymnasium after school by research staff. Heart rate monitors documented each child's average heart rate on a daily basis. Small incentives were offered for achieving goal of >150 bpm average HR each day and attending at least 80% of sessions (4 days/week). | Behavioural | High dose, Low Dose |
Primary outcome
Insulin area under the curve (oral glucose tolerance test)
Time frame: 10-15 weeks
Body composition (% body fat, visceral fat)
Time frame: 10-15 weeks
Aerobic fitness
Time frame: 10-15 weeks
Cognition (Executive function)
Time frame: 10-15 weeks
5 secondary outcomes
Glucose (oral glucose tolerance test)
Time frame: 10-15 weeks
Lipid profile
Time frame: 10-15 weeks
Inflammation (C-reactive protein, fibrinogen)
Time frame: 10-15 weeks
Blood pressure
Time frame: 10-15 weeks
Academic achievement
Time frame: 10-15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Results publication: PubMed 17135615Davis CL, Tkacz J, Gregoski M, Boyle CA, Lovrekovic G. Aerobic exercise and snoring in overweight children: a randomized controlled trial. Obesity (Silver Spring). 2006 Nov;14(11):1985-91. doi: 10.1038/oby.2006.232.
- Results publication: PubMed 18274222Davis CL, Tomporowski PD, Boyle CA, Waller JL, Miller PH, Naglieri JA, Gregoski M. Effects of aerobic exercise on overweight children's cognitive functioning: a randomized controlled trial. Res Q Exerc Sport. 2007 Dec;78(5):510-9. doi: 10.1080/02701367.2007.10599450.
- Results publication: PubMed 19777141Tomporowski PD, Davis CL, Miller PH, Naglieri JA. Exercise and Children's Intelligence, Cognition, and Academic Achievement. Educ Psychol Rev. 2008 Jun 1;20(2):111-131. doi: 10.1007/s10648-007-9057-0.
- Derived from this study: PubMed 22990269Davis CL, Pollock NK, Waller JL, Allison JD, Dennis BA, Bassali R, Melendez A, Boyle CA, Gower BA. Exercise dose and diabetes risk in overweight and obese children: a randomized controlled trial. JAMA. 2012 Sep 19;308(11):1103-12. doi: 10.1001/2012.jama.10762.
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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.
Catherine L Davis, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise program in people with Obesity and Type 2 Diabetes Prevention, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Dec 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 area under the curve (oral glucose tolerance test) (time frame: 10-15 weeks). The study lists 4 primary outcomes in all. 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 NCT00108901, which also lists 4 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 24 Dec 2014.