Childhood ObesityNCT00477477
Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors (PowerUp)
A study testing Diet in people with Childhood Obesity and Dyslipidemia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a low saturated fat diet, in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol problems. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Childhood Obesity, Dyslipidemia, Insulin Resistance
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Sep 2012
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 8 to 17 years old
- Overweight, defined as BMI ≥ 85th%tile for age and gender
- At least two CV risk factor typical of the metabolic syndrome including insulin resistance, high or borderline blood pressure, low HDL, high TG
- Insulin > 10 u/L
- Able to attend study visits once a week at participant's home, and eat meals provided by the Children's Hospital CTSA Boston MA as supplied for most meals and snacks
- Non-smoker
- Able to understand/speak English
- Informed consent to participate from a parent or legal guardian. Adolescents must also provide written assent to participate in the study.
Who cannot join
- Pre-existing physician diagnosis of a major medical illness or history of a major medical illness including but not limited to heart, kidney or liver disease, cancer, endocrinopathy including thyroid disorder, genetic syndrome or psychiatric illness, also including vasculitides such as Kawasaki disease or rheumatologic disorder; diabetes type I or II, evidence of severe fatty liver, hypertension requiring pharmacologic treatment, history of or current diagnosis of an major eating disorder
- Current or anticipated pregnancy
- Weight more than 275 lbs (125 kg)
- Abnormalities on initial screening assessment requiring pharmacotherapy urgent treatment, such as familial hyperlipidemia, end organ effects of hypertension, or metabolic abnormalities such as diabetes
- Taking any prescription medication or non-prescription substance that affects cholesterol levels, blood pressure, or insulin sensitivity (including but not limited to oral glucocorticoids, oral contraceptives, neuropsychiatric agents, anti-epileptics, HMG-CoA reductase inhibitors, bile acid binding cholesterol transport inhibitors among others) and the use of alcohol or illicit substances.
- Anticipated difficulty with participatory requirements of the study including food allergies, significantly restricted food preferences, or other difficulties as assessed by research staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors
This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a low saturated fat diet, in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol problems. The objective of the study is to determine which diet improves these risk factors more. The design of the study is a modified feeding study, which requests that the participants eat all and only the food provided by the study for 8 weeks, most days per week. Dietary counseling by phone will continue between 2 and 6 months of the study and the effects of this maintenance period will be assessed at 6 months time.
Read the detailed description
The prevalence of obesity and overweight among children is high, and increasing. Metabolic syndrome, a recently recognized consequence of obesity, is known to confer an elevated risk for cardiovascular (CV) disease and diabetes type 2 in adults. The primary treatment for metabolic syndrome is lifestyle modification, including dietary changes. However, little is known about how dietary composition, as distinct from decreased caloric intake and weight loss, alters metabolic syndrome abnormalities in children. Moreover, the optimal pediatric nutritional strategy for prevention and treatment of metabolic syndrome is unknown. The overall goal of this research protocol is to evaluate two nutritional approaches to pediatric metabolic syndrome in post-pubertal overweight adolescents, a low saturated fat diet and a low glycemic load (GL) diet. The design of the protocol is a short-term, modified feeding study that evaluates the efficacy of these two nutritional approaches with equal weight loss goals. Outcome measures will include the percent changes from baseline to the end of the intervention period (8 weeks) in metabolic abnormalities, inflammatory cytokines and adipokines, and non-invasive tests of vascular function. Metabolomic profiles are measured at baseline and 8 weeks in a subset of the participants.
To facilitate compliance and adherence, participants chose from a menu of food choices and food will be delivered to participants homes to supply most of the meals and snacks participants consume. Participants will receive weekly personal nutritional counseling to enhance compliance with frequent phone follow-up. Subsequent to the feeding portion of the intervention, participants are counselled by phone at least on a monthly basis and the effects of this maintenance phase is measured at 6 months.
- Conditions
- Childhood Obesity, Dyslipidemia, Insulin Resistance, Hypertension
- Being tested
- Diet
- Keywords
- overweight, metabolic syndrome, adolescent, cardiovascular, risk factors, hypertension, dyslipidemia, inflammation, coagulopathy
- Medical subject headings
- Pediatric Obesity, Dyslipidemias, Insulin Resistance, Hypertension, Overweight, Metabolic Syndrome, Inflammation, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Low glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
DietOther
Low saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low glycemic load diet Receives: Other: Diet |
| 2 | Active comparator | Low fat diet Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Measured: 8 weeks, 6 months
Secondary outcomes (7)
Inflammation
Measured: 8 weeks, 6 months
dyslipidemia
Measured: 8 weeks, 6 months
blood pressure
Measured: 8 weeks, 6 months
coagulopathy
Measured: 8 weeks, 6 months
vascular function
Measured: 8 weeks, 6 months
liver function testing
Measured: 8 weeks, 6 months
Metabolomic profile
The metabolomic profile of a subset of the participants will be measured at baseline and 8 weeks.
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2012
- Study completionSep 2012
Why it stopped: Inadequate enrollment and lack of funds.
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 Boston Children's HospitalThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sarah D. de Ferranti, Boston Children's Hospital
- Investigators
- Sarah D. de Ferranti, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477477
- Sponsor's protocol ID
- 07-01-0020
- Other IDs
- K23HL085308
- Status last verified
- Oct 2014
- First submitted
- 22 May 2007
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00477477
- Acronym / sponsor ID
- 07-01-0020
- Conditions
- Childhood Obesity, Dyslipidemia, Insulin Resistance, Hypertension
- Keywords
- overweight, metabolic syndrome, adolescent, cardiovascular, risk factors, hypertension, dyslipidemia, inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment and lack of funds.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2007
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 May 2007 (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.
This study is designed to evaluate the efficacy of two diets, a low glycemic load diet and a low saturated fat diet, in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high blood pressure, pre-diabetes, and cholesterol problems. The objective of the study is to determine which diet improves these risk factors more. The design of the study is a modified feeding study, which requests that the participants eat all and only the food provided by the study for 8 weeks, most days per week. Dietary counseling by phone will continue between 2 and 6 months of the study and the effects of this maintenance period will be assessed at 6 months time.
Detailed description
The prevalence of obesity and overweight among children is high, and increasing. Metabolic syndrome, a recently recognized consequence of obesity, is known to confer an elevated risk for cardiovascular (CV) disease and diabetes type 2 in adults. The primary treatment for metabolic syndrome is lifestyle modification, including dietary changes. However, little is known about how dietary composition, as distinct from decreased caloric intake and weight loss, alters metabolic syndrome abnormalities in children. Moreover, the optimal pediatric nutritional strategy for prevention and treatment of metabolic syndrome is unknown. The overall goal of this research protocol is to evaluate two nutritional approaches to pediatric metabolic syndrome in post-pubertal overweight adolescents, a low saturated fat diet and a low glycemic load (GL) diet. The design of the protocol is a short-term, modified feeding study that evaluates the efficacy of these two nutritional approaches with equal weight loss goals. Outcome measures will include the percent changes from baseline to the end of the intervention period (8 weeks) in metabolic abnormalities, inflammatory cytokines and adipokines, and non-invasive tests of vascular function. Metabolomic profiles are measured at baseline and 8 weeks in a subset of the participants.
To facilitate compliance and adherence, participants chose from a menu of food choices and food will be delivered to participants homes to supply most of the meals and snacks participants consume. Participants will receive weekly personal nutritional counseling to enhance compliance with frequent phone follow-up. Subsequent to the feeding portion of the intervention, participants are counselled by phone at least on a monthly basis and the effects of this maintenance phase is measured at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: DietLow glycemic load diet |
| 2 | Active comparator | Other: DietLow fat diet |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Ages 8 to 17 years old
- Overweight, defined as BMI ≥ 85th%tile for age and gender
- At least two CV risk factor typical of the metabolic syndrome including insulin resistance, high or borderline blood pressure, low HDL, high TG
- Insulin > 10 u/L
- Able to attend study visits once a week at participant's home, and eat meals provided by the Children's Hospital CTSA Boston MA as supplied for most meals and snacks
Key exclusion criteria (6 listed)
- Pre-existing physician diagnosis of a major medical illness or history of a major medical illness including but not limited to heart, kidney or liver disease, cancer, endocrinopathy including thyroid disorder, genetic syndrome or psychiatric illness, also including vasculitides such as Kawasaki disease or rheumatologic disorder; diabetes type I or II, evidence of severe fatty liver, hypertension requiring pharmacologic treatment, history of or current diagnosis of an major eating disorder
- Current or anticipated pregnancy
- Weight more than 275 lbs (125 kg)
- Abnormalities on initial screening assessment requiring pharmacotherapy urgent treatment, such as familial hyperlipidemia, end organ effects of hypertension, or metabolic abnormalities such as diabetes
- Taking any prescription medication or non-prescription substance that affects cholesterol levels, blood pressure, or insulin sensitivity (including but not limited to oral glucocorticoids, oral contraceptives, neuropsychiatric agents, anti-epileptics, HMG-CoA reductase inhibitors, bile acid binding cholesterol transport inhibitors among others) and the use of alcohol or illicit substances.
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 |
|---|---|---|
| DietLow glycemic load diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin. | Other | 1 |
| DietLow saturated fat diet prepared/delivered for 8 weeks, and counseled for 4 more months. Daily multivitamin. | Other | 2 |
Primary outcome
Insulin resistance
Time frame: 8 weeks, 6 months
7 secondary outcomes
Inflammation
Time frame: 8 weeks, 6 months
dyslipidemia
Time frame: 8 weeks, 6 months
blood pressure
Time frame: 8 weeks, 6 months
coagulopathy
Time frame: 8 weeks, 6 months
vascular function
Time frame: 8 weeks, 6 months
liver function testing
Time frame: 8 weeks, 6 months
Metabolomic profile
Time frame: baseline, 8 weeks
Results and safety
The study was stopped early (reason given: Inadequate enrollment and lack of funds.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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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.
Sarah D. de Ferranti principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Childhood Obesity and Dyslipidemia, run by Boston Children's Hospital 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 8 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 27 Oct 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.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment and lack of funds.). 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 resistance (time frame: 8 weeks, 6 months). 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 27 Oct 2014.