The Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes.
The Corazón de la Familia study is a randomized controlled trial conducted to examine if a novel family-focused lifestyle modification intervention is more effective in reducing risk for type 2 diabetes and cardiovascular disease (CVD) than an individual-focused lifestyle modification intervention. We will enroll 220 Hispanic family pairs or dyads, of whom one member has two or more risk factors for type 2 diabetes or CVD but does not have type 2 diabetes or CVD. The second member of the family dyad may or may not have type 2 diabetes or CVD or may or may not be at risk for type 2 diabetes or CVD. Of the 220 family dyads, 110 will be randomly selected to participate in the family-focused intervention and 110 will be randomly selected to participate in the individual-focused intervention. The interventions for both groups will be provided by community health workers. Both groups will receive eight educational sessions about healthy lifestyle behaviors and support to address personal and environmental barriers to engaging in healthy behaviors. After the eight sessions, the community health workers will follow up with participants once a month by phone over the next 12 months. Primary outcomes include short-term and long-term impact of the family-focused active intervention compared to the individual-focused control condition on type 2 diabetes and CVD biological risk factors (for example, blood pressure and weight) and behavioral risk factors (for example, physical activity and tobacco use). Outcomes are measured at baseline, immediately post-intervention, and at the end of the 12 month period of the study for both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
526
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.
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.
University of Kentucky
Lexington, Kentucky, United States
Change in body mass index (BMI)
BMI based on measurements of weight and height and calculated as kg/m2
Time frame: Baseline, 3 months, and 12 months
Change in blood pressure
Blood pressure assessed using calibrated sphygmomanometry
Time frame: Baseline, 3 months, and 12 months
Change in lipid profile
Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.
Time frame: Baseline, 3 months, and 12 months
Change in hemoglobin A1c (HbA1c)
HbA1c measured using point-of-care testing obtained by fingerstick.
Time frame: Baseline, 3 months, and 12 months
Change in level of physical activity
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ) to assess the number of days in the last 7 days that the participant engaged in vigorous or moderate physical activity and confirmed by comparing responses to number of daily steps over 7 days assessed with a Fitbit
Time frame: Baseline, 3 months, and 12 months
Change in diet quality
Diet quality will be measured using the Food Frequency Questionnaire
Time frame: Baseline, 3 months, and 12 months
Change in tobacco use
Urine cotinine levels will be used to assess tobacco use
Time frame: Baseline, 3 months, and 12 months
Support for healthy behaviors
Self report of experience of social support for healthy behaviors
Time frame: Baseline, 3 months, and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.