Childhood ObesityNCT00215111
Role of Carbohydrate Modification in Weight Management Among Obese Children
A study of Childhood Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2008
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7-12 years
- Body mass index >95th percentile and BMI z-score no greater than 2.65
- Normal fasting blood glucose of less than 100 mg/dL
- Age-appropriate cognitive and behavioral skills
- Absence of developmental or physical disabilities
- Capability to function independently in group exercise sessions
- Commitment of parent/guardian to attend scheduled meetings for 12-month period
Who cannot join
- Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia
- Chronic infections
- Uncompensated or labile mental illness
- Chronic or intermittent use of corticosteroids
- Specific medications that may alter lipid, glucose, bone metabolism or appetite
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. In addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children.
Read the detailed description
The treatment of pediatric obesity supported by the medical community is a moderate restriction in calories by modifying intake of fat and simple sugars, along with an increase in energy expenditure through more physical activity. However, this approach is associated with only limited success. As a result, overweight children and adolescents are seeking alternative approaches to weight management, such as diets that modify the type and amount of carbohydrates. However, at this time there is limited data on the safety and efficacy of these diets, particularly with younger children. This study is a controlled clinical trial that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets to a more standard dietary intervention for the management of pediatric obesity (i.e. portion-controlled, moderate fat, high carbohydrate diet). This study will involve 150 overweight children (ages 7 to 12) who will be randomly assigned to one of the three diet groups for 12 months. The effects of each diet will be determined by measuring changes in anthropometric measures (body weight, height, body mass index, waist circumference, body composition), other cardiovascular risk factors (blood pressure, fasting lipid profile, fasting glucose and insulin, and inflammatory markers of cardiovascular disease), and measures of psychological well-being and mental status. The results of this study will provide needed information to the public in their quest for safe, effective, and health-promoting weight management strategies for obese children. Such information is vital if we are to address the obesity epidemic in the United States.
- Conditions
- Childhood Obesity
- Being tested
- Low carbohydrate, reduced glycemic load, and a control diet
- Keywords
- childhood obesity, weight management, dietary interventions, cardiovascular disease risk factors
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate, reduced glycemic load, and a control dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate, reduced glycemic load, control diet | Experimental | Not described Receives: Behavioral: Low carbohydrate, reduced glycemic load, and a control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcomes listed below will be obtained at baseline,3-month,
Measured: 3 month
6-month and 12-month assessments unless otherwise noted,body weight,
Measured: 6-month and 12-month
height,body mass index,waist circumference,percent body fat,
Measured: baseline, 3-month, 6-month and 12-month
adipose mass,lean body mass,bone mineral density,fasting lipid profile,
Measured: baseline, 3-month, 6-month and 12-month
fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),
Measured: baseline, 3-month, 6-month and 12-month
Secondary outcomes (6)
physical activity (3-day physical activity records and pedometer readings)
Measured: 3-month, 6-month and 12-month
compliance with behavioral intervention (frequency rewards were earned)
Measured: weekly
attendance at group and individual sessions during initial 3-month intervention
Measured: 3-month, 6-month and 12-month
Sexual Maturity Rating
Measured: baseline
Hunger/Satiety assessment (Three-Factor Eating Questionnaire)
Measured: baseline, 3-month, 6-month and 12-month
Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Shelley Kirk, Ph.D., R.D., L.D., Children's Hospital Medical Center, Cincinnati
- Investigators
- Shelley Kirk, Ph.D., R.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215111
- Sponsor's protocol ID
- 02819-8
- Status last verified
- Feb 2015
- First submitted
- 15 Sep 2005
- Last updated
- 5 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Carbohydrate Modification in Weight Management Among Obese Children
- ClinicalTrials.gov ID
- NCT00215111
- Acronym / sponsor ID
- 02819-8
- Conditions
- Childhood Obesity
- Keywords
- childhood obesity, weight management, dietary interventions, cardiovascular disease risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Mar 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Sep 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 purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. In addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children.
Detailed description
The treatment of pediatric obesity supported by the medical community is a moderate restriction in calories by modifying intake of fat and simple sugars, along with an increase in energy expenditure through more physical activity. However, this approach is associated with only limited success. As a result, overweight children and adolescents are seeking alternative approaches to weight management, such as diets that modify the type and amount of carbohydrates. However, at this time there is limited data on the safety and efficacy of these diets, particularly with younger children. This study is a controlled clinical trial that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets to a more standard dietary intervention for the management of pediatric obesity (i.e. portion-controlled, moderate fat, high carbohydrate diet). This study will involve 150 overweight children (ages 7 to 12) who will be randomly assigned to one of the three diet groups for 12 months. The effects of each diet will be determined by measuring changes in anthropometric measures (body weight, height, body mass index, waist circumference, body composition), other cardiovascular risk factors (blood pressure, fasting lipid profile, fasting glucose and insulin, and inflammatory markers of cardiovascular disease), and measures of psychological well-being and mental status. The results of this study will provide needed information to the public in their quest for safe, effective, and health-promoting weight management strategies for obese children. Such information is vital if we are to address the obesity epidemic in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate, reduced glycemic load, control diet | Experimental | Behavioral: Low carbohydrate, reduced glycemic load, and a control diet |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 7-12 years
- Body mass index >95th percentile and BMI z-score no greater than 2.65
- Normal fasting blood glucose of less than 100 mg/dL
- Age-appropriate cognitive and behavioral skills
- Absence of developmental or physical disabilities
Key exclusion criteria (5 listed)
- Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia
- Chronic infections
- Uncompensated or labile mental illness
- Chronic or intermittent use of corticosteroids
- Specific medications that may alter lipid, glucose, bone metabolism or appetite
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 |
|---|---|---|
| Low carbohydrate, reduced glycemic load, and a control diet | Behavioural | Low carbohydrate, reduced glycemic load, control diet |
Primary outcome
The outcomes listed below will be obtained at baseline,3-month,
Time frame: 3 month
6-month and 12-month assessments unless otherwise noted,body weight,
Time frame: 6-month and 12-month
height,body mass index,waist circumference,percent body fat,
Time frame: baseline, 3-month, 6-month and 12-month
adipose mass,lean body mass,bone mineral density,fasting lipid profile,
Time frame: baseline, 3-month, 6-month and 12-month
fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),
Time frame: baseline, 3-month, 6-month and 12-month
6 secondary outcomes
physical activity (3-day physical activity records and pedometer readings)
Time frame: 3-month, 6-month and 12-month
compliance with behavioral intervention (frequency rewards were earned)
Time frame: weekly
attendance at group and individual sessions during initial 3-month intervention
Time frame: 3-month, 6-month and 12-month
Sexual Maturity Rating
Time frame: baseline
Hunger/Satiety assessment (Three-Factor Eating Questionnaire)
Time frame: baseline, 3-month, 6-month and 12-month
Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group
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 5 Feb 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.
Shelley Kirk, Ph.D., R.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Childhood Obesity, run by Children's Hospital Medical Center, Cincinnati 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 7 inclusion and 5 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 5 Feb 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?
The outcomes listed below will be obtained at baseline,3-month, (time frame: 3 month). The study lists 5 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 5 Feb 2015.