- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196024
Corazon de la Familia (Heart of the Family)
A Randomized Controlled Trial to Examine a Healthy Lifestyle Intervention With Families to Prevent Cardiovascular Disease and Type 2 Diabetes in Hispanics/Latinos
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Kentucky
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Lexington, Kentucky, United States, 40536-0232
- University of Kentucky
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Family-focused intervention arm
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.
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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.
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Active Comparator: Individual-focused intervention arm
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body mass index (BMI)
Time Frame: Baseline, 3 months, and 12 months
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BMI based on measurements of weight and height and calculated as kg/m2
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Baseline, 3 months, and 12 months
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Change in blood pressure
Time Frame: Baseline, 3 months, and 12 months
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Blood pressure assessed using calibrated sphygmomanometry
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Baseline, 3 months, and 12 months
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Change in lipid profile
Time Frame: Baseline, 3 months, and 12 months
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Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.
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Baseline, 3 months, and 12 months
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Change in hemoglobin A1c (HbA1c)
Time Frame: Baseline, 3 months, and 12 months
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HbA1c measured using point-of-care testing obtained by fingerstick.
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Baseline, 3 months, and 12 months
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Change in level of physical activity
Time Frame: Baseline, 3 months, and 12 months
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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
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Baseline, 3 months, and 12 months
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Change in diet quality
Time Frame: Baseline, 3 months, and 12 months
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Diet quality will be measured using the Food Frequency Questionnaire
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Baseline, 3 months, and 12 months
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Change in tobacco use
Time Frame: Baseline, 3 months, and 12 months
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Urine cotinine levels will be used to assess tobacco use
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Baseline, 3 months, and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Support for healthy behaviors
Time Frame: Baseline, 3 months, and 12 months
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Self report of experience of social support for healthy behaviors
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Baseline, 3 months, and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gia Mudd-Martin, PhD, RN, University of Kentucky
- Study Director: Rosa Martin, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01NR016262-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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