Overweight and ObesitySMARTNCT02383485
Nonalcoholic Fatty Liver Disease and Atherosclerotic Risk in Children
A study testing Exercise and After-school program in people with Overweight and Obesity and Non-alcoholic Fatty Liver Disease, run by Augusta University at 1 site in United States.
Trial summary
Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Non-alcoholic Fatty Liver Disease
- What is being tested?
- Exercise and After-school program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Apr 2014
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-11 years of age
- Overweight or obese (BMI-for-age >= 85th percentile)
- Able to participate in exercise testing and intervention
- Participating in the SMART Study
Who cannot join
- Medical condition or medications that would interfere with measurements
- Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
- T-score > 75 on the BRIEF Behavior Regulation scale to avoid program disruption
- Unable to complete magnetic resonance imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Prevention Institute
Augusta, Georgia, 30912
About this study
Official title: Exercise and Overweight Children's Cognition (Supplement)
Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program.
Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.
Read the detailed description
This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.
- Being tested
- Exercise, After-school program
- Keywords
- arterial stiffness
- Medical subject headings
- Overweight, Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Aerobic training
Heart rate monitors worn by each child at each session
After-school programBehavioural
Supervised recreational program with token economy
| Study group | Role | What they receive |
|---|---|---|
| After-school exercise program | Experimental | 40 min/day vigorous aerobic games after school Receives: Behavioral: Exercise; Behavioral: After-school program |
| Sedentary after-school program | Active comparator | Attention-control condition similar to experimental condition with the exception of exercise Receives: Behavioral: After-school program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Fat
Change in the proportion of liver fat via MRI
Measured: Baseline, 8 Months
Change in Arterial Stiffness
Change in carotid-femoral pulse wave velocity
Measured: Baseline, 8 Months
Secondary outcomes (4)
Change in Liver Fibrosis
Change in Fibroscan transient elastography measure
Measured: Baseline, 8 Months
Change in Liver Inflammation
Change in ratio of aspartate aminotransferase to alanine aminotransferase (AST/ALT), C-reactive protein
Measured: Baseline, 8 Months
Change in Quality of Life
Change in PedsQL questionnaire responses
Measured: Baseline, 8 Months
Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices
At baseline, the proportion of liver fat (ascertained by MRI) will be closely related to indices of liver fibrosis (as detected by transient elastography) and inflammation (ratio of aspartate aminotransferase to alanine aminotransferase, AST/ALT; C-reactive protein, CRP), and to arterial stiffness and other indices of cardiovascular risk (body fat (DXA), visceral fat (MRI), aerobic fitness, insulin resistance, adiponectin, dyslipidemia).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMay 2008
- Primary completionMay 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Catherine Davis, Augusta University
- Investigators
- Catherine L Davis, PhD, Principal investigator, 706-721-9551
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383485
- Sponsor's protocol ID
- R01HL087923-02S1
- Other IDs
- R01HL087923-02S1
- Acronym
- SMART
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Overweight Children's Cognition (Supplement)
- ClinicalTrials.gov ID
- NCT02383485
- Acronym / sponsor ID
- SMART / R01HL087923-02S1
- Keywords
- arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Mar 2015 (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.
Nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. This project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program.
Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.
Detailed description
This is an ancillary study adding cardiometabolic outcome measures to an ongoing NIH-funded randomized trial of exercise in overweight children ("SMART study," R01 HL087923, P.I. Davis, NCT02227095). This presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After-school exercise program | Experimental | Behavioral: Exercise, Behavioral: After-school program40 min/day vigorous aerobic games after school |
| Sedentary after-school program | Active comparator | Behavioral: After-school programAttention-control condition similar to experimental condition with the exception of exercise |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 8-11 years of age
- Overweight or obese (BMI-for-age >= 85th percentile)
- Able to participate in exercise testing and intervention
- Participating in the SMART Study
Key exclusion criteria (4 listed)
- Medical condition or medications that would interfere with measurements
- Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
- T-score > 75 on the BRIEF Behavior Regulation scale to avoid program disruption
- Unable to complete magnetic resonance imaging.
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 |
|---|---|---|
| ExerciseAlso: Aerobic trainingHeart rate monitors worn by each child at each session | Behavioural | After-school exercise program |
| After-school programSupervised recreational program with token economy | Behavioural | After-school exercise program, Sedentary after-school program |
Primary outcome
Change in Liver Fat
Time frame: Baseline, 8 Months
Change in the proportion of liver fat via MRI
Change in Arterial Stiffness
Time frame: Baseline, 8 Months
Change in carotid-femoral pulse wave velocity
4 secondary outcomes
Change in Liver Fibrosis
Time frame: Baseline, 8 Months
Change in Liver Inflammation
Time frame: Baseline, 8 Months
Change in Quality of Life
Time frame: Baseline, 8 Months
Associations among Liver Fat, Fibrosis and Inflammation, Arterial Stiffness, and Other Cardiovascular Risk Indices
Time frame: Baseline
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 9 Mar 2015.
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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
706-721-9551
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and After-school program in people with Overweight and Obesity and Non-alcoholic Fatty Liver Disease, run by Augusta University 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 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 9 Mar 2015. 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 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?
Change in Liver Fat (time frame: Baseline, 8 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2015.