Corazon de la Familia (Heart of the Family)

NACompletedINTERVENTIONAL
Enrollment

526

Participants

Timeline

Start Date

October 5, 2017

Primary Completion Date

December 23, 2023

Study Completion Date

December 23, 2023

Conditions
Risk Reduction BehaviorDiabetes Mellitus, Type 2Cardiovascular Diseases
Interventions
BEHAVIORAL

Family-focused intervention arm

Family pairs including an individual family member at-risk for type 2 diabetes or CVD and a co-participating family member will be enrolled in the study. After completing baseline data they will be randomly selected to participate in one of the two study arms. For the family-focused arm, the family pair will attend 8 2-hour weekly educational sessions about type 2 diabetes and CVD risk reducing lifestyle behaviors. The sessions will be presented by community health workers (CHWs) in Spanish to groups of 5 to 6 family pairs. Following completion of the sessions, data will be collected from the family pairs. CHWs will call monthly to provide information and support through the end of the 12-month period at which time data will be collected from the family pairs.

BEHAVIORAL

Individual-focused intervention arm

Family pairs including an individual family member at-risk for type 2 diabetes or CVD and co-participating family member will be enrolled in the study. After completing baseline data pairs will be randomly selected to participate in one of two interventions. For the individual-focused intervention, the at-risk individual will attend 8 weekly 2-hour education sessions on type 2 diabetes and CVD risk reducing lifestyle behaviors. Sessions will be presented by CHWs in Spanish to groups of 10 to 12 individuals. Following completion of sessions, data will be collected from the individuals. CHWs will call monthly to provide information and support through the end of the 12-month period at which time data will be collected from the at-risk individuals and their co-participating family members.

Trial Locations (1)

40536-0232

University of Kentucky, Lexington

All Listed Sponsors
collaborator

National Institute of Nursing Research (NINR)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Gia Mudd

OTHER

NCT03196024 - Corazon de la Familia (Heart of the Family) | Biotech Hunter | Biotech Hunter