Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517459
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as HispanicLatino
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as HispanicLatino
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to examine weight loss for HispanicLatino people with stroke CVA who take part in a healthy lifestyle program that has been culturally modified for HispanicLatino people
Detailed Description:
Weight gain greatly increases the risk of chronic diseases such as diabetes metabolic syndrome pulmonary and heart disease The Group Lifestyle Balance GLB intervention is a 12-month evidence-based weight-loss program that has been used extensively with the general population and with people after CVA however it is not adapted to be linguistically and culturally appropriate for Latino persons post stroke We will modified the program to meet the needs of Latino people with a CVA GLB-CVA Latino
Aims
1 To create a modification of the CDC-recognized evidence-based GLB-CVA to be culturally appropriate to meet the unique needs of people who identify as HispanicLatino available in English and Spanish languages using a Community-Based Participatory Research approach and AB of key stakeholders patients caregivers clinicians researchers
2 Conduct a single-arm trial to describe the effect of participation in the GLB-CVA Latino on primary and secondary outcomes for 24 individuals who identify as HispanicLatino 12 English speakers and 12 Spanish speakers at 3 6 and 12 months from baseline
3 Evaluate the participant compliance feasibility and fidelity adherence to the DPP GLB content with the GLB-CVA Latino intervention
Aims
1 To create a modification of the CDC-recognized evidence-based GLB-CVA to be culturally appropriate to meet the unique needs of people who identify as HispanicLatino available in English and Spanish languages using a Community-Based Participatory Research approach and AB of key stakeholders patients caregivers clinicians researchers
2 Conduct a single-arm trial to describe the effect of participation in the GLB-CVA Latino on primary and secondary outcomes for 24 individuals who identify as HispanicLatino 12 English speakers and 12 Spanish speakers at 3 6 and 12 months from baseline
3 Evaluate the participant compliance feasibility and fidelity adherence to the DPP GLB content with the GLB-CVA Latino intervention
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