Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477477
Status:
TERMINATED
Last Update Posted:
2014-10-27
First Post:
2007-05-22
Brief Title:
Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors PowerUp
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate enrollment and lack of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL085308 | NIH | None | httpsreporternihgovquickSearchK23HL085308 |