Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005718
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Evaluation of Cholesterol Education for At-Risk Children
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate two educational programs that promoted the role of pediatric practices in lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through dietary modification
Detailed Description:
BACKGROUND
Outcomes of the study provided valuable guidance for pediatricians who wanted to become more actively involved in identifying and treating children with elevated blood lipids
DESIGN NARRATIVE
Pediatricians in five practices in Abington Pennsylvania conducted a cholesterol screening program capillary bloodsample for 4-10 year old children in their care Children who tested positive total cholesterol 176 mgdl were offered follow-up evaluations two fasting venous blood samples to confirm the positive initial test Those with mean LDL cholesterol levels between the 80th and 98th percentiles for agesex 107-164 mgdl for boys and 112-164 mgdl for girls and who met other entry criteria were invited to join the study Children with parental permission to participate were randomized to one of three groups two that received dietary education and a comparison group that received no dietary education One educational program used face-to-face counseling with a registered dietitian and the other used a home-based parent-child autotutorial approach In addition a random sample of non-hypercholesterolemic children with total plasma cholesterol levels between the 40th and 60th percentiles for agesex were invited to join the study as a second comparison group Prior to the education period baseline and three times thereafter 3 6 and 12 months post-baseline all four groups were assessed for consumption of total fat saturated fat and cholesterol and their growth and pertinent cognitive psychosocial factors Also the plasma LDL cholesterol levels of the three hypercholesterolemic groups were assessed at all four time points along with blood indicators of iron status at baseline and twelve months
To assess the educational programs effectiveness changes were compared in assessed variables of the hypercholesterolemic groups who did and did not receive dietary education Also changes in diet growth and cognitivepsychosocial factors in these groups were compared with those of the non-hypercholesterolemic group that had neither a positive diagnosis of elevated blood lipids nor dietary education Additionally the cost-effectiveness of the two dietary education programs was evaluated
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Outcomes of the study provided valuable guidance for pediatricians who wanted to become more actively involved in identifying and treating children with elevated blood lipids
DESIGN NARRATIVE
Pediatricians in five practices in Abington Pennsylvania conducted a cholesterol screening program capillary bloodsample for 4-10 year old children in their care Children who tested positive total cholesterol 176 mgdl were offered follow-up evaluations two fasting venous blood samples to confirm the positive initial test Those with mean LDL cholesterol levels between the 80th and 98th percentiles for agesex 107-164 mgdl for boys and 112-164 mgdl for girls and who met other entry criteria were invited to join the study Children with parental permission to participate were randomized to one of three groups two that received dietary education and a comparison group that received no dietary education One educational program used face-to-face counseling with a registered dietitian and the other used a home-based parent-child autotutorial approach In addition a random sample of non-hypercholesterolemic children with total plasma cholesterol levels between the 40th and 60th percentiles for agesex were invited to join the study as a second comparison group Prior to the education period baseline and three times thereafter 3 6 and 12 months post-baseline all four groups were assessed for consumption of total fat saturated fat and cholesterol and their growth and pertinent cognitive psychosocial factors Also the plasma LDL cholesterol levels of the three hypercholesterolemic groups were assessed at all four time points along with blood indicators of iron status at baseline and twelve months
To assess the educational programs effectiveness changes were compared in assessed variables of the hypercholesterolemic groups who did and did not receive dietary education Also changes in diet growth and cognitivepsychosocial factors in these groups were compared with those of the non-hypercholesterolemic group that had neither a positive diagnosis of elevated blood lipids nor dietary education Additionally the cost-effectiveness of the two dietary education programs was evaluated
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL043880 | NIH | None | httpsreporternihgovquickSearchR01HL043880 |