Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005694
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Worksites Occupational Nurses and Cholesterol Change
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 study the relative effectiveness of teaching occupational nurses to conduct cholesterol screening counseling and referral events SCOREs in their own worksites versus using an external organization to implement these programs Also to study the relative effectiveness of face-to-face behavior change counseling following the cholesterol measurement versus automated feedback of essentially the same individualized educational material
Detailed Description:
DESIGN NARRATIVE
The research design was a 2 x 2 design with repeated measures at six and 12 months after the baseline measurement and treatment application The investigators tested the relative effectiveness of two major dimensions of blood cholesterol change programming in worksites of 250 - 800 employees with at least one occupational nurse The overall design was 2 x 2 with 10 of 25 worksites randomly assigned to an Internal Condition and 10 worksites assigned to an External Condition In the Internal Condition occupational nurses were trained by project staff to implement the SCOREs and were given Reflotron portable dry chemistry analyzers to measure cholesterol In the External Condition the SCORE was conducted by an external organization project staff Five 5 worksites from each of the above conditions had the educational session of the SCORE delivered face-to-face Face-to-Face condition FF by either the nurse or project staff depending on the condition Internal FF or External FF The other 10 worksites had this education delivered by a microcomputeroptical scanner the RT 2000 that read the participants risk factor and self-reported eating pattern information and delivered a print-out with recommendations that were prioritized and individualized for the participant RT intervention was delivered by the nurse or project staff depending on the condition Internal RT or External RT All SCORE participants in the above 20 worksites also received a self-help nutrition change kit This cross design allowed testing for possible interaction effects
Another group of five worksites was also included which served as a comparison group for the External Condition The employees in this group received a screening and education experience similar to the usual type of program offered by external commercial screeners with minimal written education materials and no individualized feedback Usual Care External Condition The primary dependent variables included measured blood cholesterol weight other CHD risk factors and self-reported eating pattern Change were assessed six and 12 months after the SCOREs were conducted A wide range of other variables including process cost and mediating variables were assessed through the project period
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The research design was a 2 x 2 design with repeated measures at six and 12 months after the baseline measurement and treatment application The investigators tested the relative effectiveness of two major dimensions of blood cholesterol change programming in worksites of 250 - 800 employees with at least one occupational nurse The overall design was 2 x 2 with 10 of 25 worksites randomly assigned to an Internal Condition and 10 worksites assigned to an External Condition In the Internal Condition occupational nurses were trained by project staff to implement the SCOREs and were given Reflotron portable dry chemistry analyzers to measure cholesterol In the External Condition the SCORE was conducted by an external organization project staff Five 5 worksites from each of the above conditions had the educational session of the SCORE delivered face-to-face Face-to-Face condition FF by either the nurse or project staff depending on the condition Internal FF or External FF The other 10 worksites had this education delivered by a microcomputeroptical scanner the RT 2000 that read the participants risk factor and self-reported eating pattern information and delivered a print-out with recommendations that were prioritized and individualized for the participant RT intervention was delivered by the nurse or project staff depending on the condition Internal RT or External RT All SCORE participants in the above 20 worksites also received a self-help nutrition change kit This cross design allowed testing for possible interaction effects
Another group of five worksites was also included which served as a comparison group for the External Condition The employees in this group received a screening and education experience similar to the usual type of program offered by external commercial screeners with minimal written education materials and no individualized feedback Usual Care External Condition The primary dependent variables included measured blood cholesterol weight other CHD risk factors and self-reported eating pattern Change were assessed six and 12 months after the SCOREs were conducted A wide range of other variables including process cost and mediating variables were assessed through the project period
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 |
|---|---|---|---|
| R01HL048250 | NIH | None | httpsreporternihgovquickSearchR01HL048250 |