Corazon de la Familia (Heart of the Family)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized Controlled Trial to Examine a Healthy Lifestyle Intervention With Families to Prevent Cardiovascular Disease and Type 2 Diabetes in Hispanics/Latinos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196024
• Other study ID #: 1R01NR016262-01A1
• Secondary ID: 1R01NR016262-01A
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: December 23, 2023

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: December 23, 2023
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

We are enrolling family dyads, or 2 family members, one of whom is at-risk for type 2 diabetes or cardiovascular disease and the second of whom is a co-participating family member who may or may not be at risk for type 2 diabetes or cardiovascular disease.

Inclusion criteria for the at-risk member of the dyad:

• Is Hispanic or Latino
• Is 18 years of age and older
• Is a primary Spanish speaker
• Has two or more risk factors for type 2 diabetes or cardiovascular disease including:

1. clinical diagnosis of hypertension;

2. clinical diagnosis of hyperlipidemia;

3. clinical diagnosis of prediabetes;

4. overweight or obese (body mass index = 25 kg/m2);

5. is a current cigarette smoker;

6. male 45 years of age or older or female 55 years of age or older;

7. family history in first degree relative of type 2 diabetes or cardiovascular disease; or

8. is a female with a history of gestational diabetes mellitus or polycystic ovary syndrome.

• Plan to be in Kentucky and Is willing to participate in the study for the next 12 months Inclusion criteria for the co-participating member of the dyad
• Is 18 years of age and older
• At a minimum, understands Spanish
• Lives in the same household or in close proximity (no further than 25 miles distance) to the at-risk member of the dyad Exclusion Criteria:

Exclusion criteria for family dyads:

• Dyads will be excluded if one or both dyad members have any of the following:
• Have cognitive impairment that preclude them from understanding the consent process, answering questionnaires, or participating in the intervention;
• Have a major psychiatric (e.g., schizophrenia) condition;
• Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different.

Exclusion criteria that apply only to the at-risk member of the dyad:

• Have known coronary artery or cerebrovascular disease;
• Have a diagnosis of type 1 or type 2 diabetes;
• Have medical contraindications to participate in a lifestyle intervention that includes unsupervised physical activity and weight loss

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Risk Reduction Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Gia Mudd	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index (BMI)	BMI based on measurements of weight and height and calculated as kg/m2	Baseline, 3 months, and 12 months
Primary	Change in blood pressure	Blood pressure assessed using calibrated sphygmomanometry	Baseline, 3 months, and 12 months
Primary	Change in lipid profile	Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.	Baseline, 3 months, and 12 months
Primary	Change in hemoglobin A1c (HbA1c)	HbA1c measured using point-of-care testing obtained by fingerstick.	Baseline, 3 months, and 12 months
Primary	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	Baseline, 3 months, and 12 months
Primary	Change in diet quality	Diet quality will be measured using the Food Frequency Questionnaire	Baseline, 3 months, and 12 months
Primary	Change in tobacco use	Urine cotinine levels will be used to assess tobacco use	Baseline, 3 months, and 12 months
Secondary	Support for healthy behaviors	Self report of experience of social support for healthy behaviors	Baseline, 3 months, and 12 months