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Corazon de la Familia (Heart of the Family)

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family-focused intervention arm

Individual-focused intervention arm

About this trial

This is an interventional prevention trial for Risk Reduction Behavior focused on measuring Diabetes; CVD; Lifestyle; Hispanic; Promotora, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Reduction Behavior, Hispanic Americans; Latinos, Community Health Workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family-focused intervention arm

Individual-focused intervention arm

Arm Description

Family-focused intervention arm: Educational sessions will be provided to family pairs that include participants who are at-risk for type 2 diabetes or CVD and their co-participating family member.

Individual-focused intervention arm: Educational sessions will be provided to the individual members of the family pairs who are at-risk for type 2 diabetes or CVD.

Outcomes

Primary Outcome Measures

Change in body mass index (BMI)

BMI based on measurements of weight and height and calculated as kg/m2

Change in blood pressure

Blood pressure assessed using calibrated sphygmomanometry

Change in lipid profile

Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.

Change in hemoglobin A1c (HbA1c)

HbA1c measured using point-of-care testing obtained by fingerstick.

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

Change in diet quality

Diet quality will be measured using the Food Frequency Questionnaire

Change in tobacco use

Urine cotinine levels will be used to assess tobacco use

Secondary Outcome Measures

Support for healthy behaviors

Self report of experience of social support for healthy behaviors

Full Information

NCT ID

NCT03196024

First Posted

June 20, 2017

Last Updated

February 3, 2023

Sponsor

Gia Mudd

Collaborators

National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03196024

Brief Title

Corazon de la Familia (Heart of the Family)

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 5, 2017 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gia Mudd

Collaborators

National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Diabetes; CVD; Lifestyle; Hispanic; Promotora, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Reduction Behavior, Hispanic Americans; Latinos, Community Health Workers

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

We will conduct a randomized controlled trial with Hispanic family dyads using a 2-group design (Corazón de la Familia active intervention versus control condition) to test effects of a type 2 diabetes and CVD risk reduction intervention at 3 (short-term) and 12 (long-term) months. For dyads randomized to the active intervention, the participant with 2 or more CVD or type 2 diabetes risk factors (index participant) and their co-participating family member will attend 8 sessions that provide type 2 diabetes and CVD risk reduction and lifestyle modification education. For dyads randomized to the control condition, only the index participant will attend 8 educational lifestyle modification sessions. Participants in both groups will receive monthly follow up phone calls up through 12 months post-baseline. The sessions for both the intervention and the control group and the monthly post-intervention phone calls will be provided by community health workers.

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

Participants, community health workers, and assessors are blinded to which arm is the active intervention and which arm is the active comparator. Participants, community health workers, and assessors will be blinded to hypotheses regarding group differences and will be informed that both groups are intervention groups and that we are examining how well both intervention types perform.

Allocation

Randomized

Enrollment

440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Family-focused intervention arm

Arm Type

Experimental

Arm Description

Family-focused intervention arm: Educational sessions will be provided to family pairs that include participants who are at-risk for type 2 diabetes or CVD and their co-participating family member.

Arm Title

Individual-focused intervention arm

Arm Type

Active Comparator

Arm Description

Individual-focused intervention arm: Educational sessions will be provided to the individual members of the family pairs who are at-risk for type 2 diabetes or CVD.

Intervention Type

Behavioral

Intervention Name(s)

Family-focused intervention arm

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Individual-focused intervention arm

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in body mass index (BMI)

Description

BMI based on measurements of weight and height and calculated as kg/m2

Time Frame

Baseline, 3 months, and 12 months

Title

Change in blood pressure

Description

Blood pressure assessed using calibrated sphygmomanometry

Time Frame

Baseline, 3 months, and 12 months

Title

Change in lipid profile

Description

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

Title

Change in hemoglobin A1c (HbA1c)

Description

HbA1c measured using point-of-care testing obtained by fingerstick.

Time Frame

Baseline, 3 months, and 12 months

Title

Change in level of physical activity

Description

Time Frame

Baseline, 3 months, and 12 months

Title

Change in diet quality

Description

Diet quality will be measured using the Food Frequency Questionnaire

Time Frame

Baseline, 3 months, and 12 months

Title

Change in tobacco use

Description

Urine cotinine levels will be used to assess tobacco use

Time Frame

Baseline, 3 months, and 12 months

Secondary Outcome Measure Information:

Title

Support for healthy behaviors

Description

Self report of experience of social support for healthy behaviors

Time Frame

Baseline, 3 months, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: clinical diagnosis of hypertension; clinical diagnosis of hyperlipidemia; clinical diagnosis of prediabetes; overweight or obese (body mass index ≥ 25 kg/m2); is a current cigarette smoker; male 45 years of age or older or female 55 years of age or older; family history in first degree relative of type 2 diabetes or cardiovascular disease; or 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gia Mudd-Martin, PhD, RN

Phone

859-257-4204

Gia.Mudd@uky.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rosa Martin

Phone

859-323-4305

Rosa.Martin@uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gia Mudd-Martin, PhD, RN

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rosa Martin

Organizational Affiliation

University of Kentucky

Official's Role

Study Director

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536-0232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gia Mudd-Martin, PhD, RN

Phone

859-494-7073

Gia.Mudd@uky.edu

First Name & Middle Initial & Last Name & Degree

Rosa Martin

Phone

859-323-4305

Rosa.Martin@uky.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified data from this study will be made available after completion of analyses for primary and secondary outcomes, and publications and research presentations that address the specific aims and major secondary analyses of the study. Data will be submitted to the Inter-university Consortium for Political and Social Research (ICPSR), a unit of the Institute for Social Research at the University of Michigan. The PI will remove all direct and indirect identifiers from the study data before submitting data to ICPSR. The ICPSR also carefully reviews submitted datasets to assure confidentiality of human subjects is preserved. All de-identified data housed by ICPSR are available to over 759 member institutions as well as to other institutions and individuals. Should access to data from this study be restricted to member institutions, the PI will, on request, provide the de-identified dataset and accompanying documentation to requesters.

IPD Sharing Time Frame

IPD Sharing Access Criteria

De-identified data from this study will be submitted to the Inter-university Consortium for Political and Social Research (ICPSR), a unit of the Institute for Social Research at the University of Michigan.All de-identified data housed by ICPSR are available to over 759 member institutions as well as to other institutions and individuals. Should access to data from this study be restricted to member institutions, the PI will, on request, provide the de-identified dataset and accompanying documentation to requesters.

Learn more about this trial

Corazon de la Familia (Heart of the Family)

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