Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-08 @ 5:51 PM
Study NCT ID:
NCT06517459
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino
Status:
RECRUITING
Status Verified Date:
2025-10
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:
The purpose of this trial is to examine weight loss for Hispanic/Latino people with stroke (CVA) who take part in a healthy lifestyle program that has been culturally modified for Hispanic/Latino 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 Hispanic/Latino, 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 Hispanic/Latino (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 Hispanic/Latino, 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 Hispanic/Latino (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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: