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Corazon de la Familia (Heart of the Family)

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ClinicalTrials.gov Identifier: NCT03196024
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Gia Mudd, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Risk Reduction Behavior Diabetes Mellitus, Type 2 Cardiovascular Diseases Behavioral: Family-focused intervention arm Behavioral: Individual-focused intervention arm Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose: Prevention
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
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

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.
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.

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.
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.




Primary Outcome Measures :
  1. Change in body mass index (BMI) [ Time Frame: Baseline, 3 months, and 12 months ]
    BMI based on measurements of weight and height and calculated as kg/m2

  2. Change in blood pressure [ Time Frame: Baseline, 3 months, and 12 months ]
    Blood pressure assessed using calibrated sphygmomanometry

  3. Change in lipid profile [ Time Frame: Baseline, 3 months, and 12 months ]
    Lipid profile includes LDL-cholesterol, HDL-cholesterol and triglycerides measured using point-of-care testing obtained by fingerstick.

  4. Change in hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 3 months, and 12 months ]
    HbA1c measured using point-of-care testing obtained by fingerstick.

  5. Change in level of physical activity [ Time Frame: Baseline, 3 months, and 12 months ]
    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

  6. Change in diet quality [ Time Frame: Baseline, 3 months, and 12 months ]
    Diet quality will be measured using the Food Frequency Questionnaire

  7. Change in tobacco use [ Time Frame: Baseline, 3 months, and 12 months ]
    Urine cotinine levels will be used to assess tobacco use


Secondary Outcome Measures :
  1. Support for healthy behaviors [ Time Frame: Baseline, 3 months, and 12 months ]
    Self report of experience of social support for healthy behaviors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196024


Contacts
Contact: Gia Mudd-Martin, PhD, RN 859-257-4204 Gia.Mudd@uky.edu
Contact: Rosa Martin 859-323-4305 Rosa.Martin@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0232
Contact: Gia Mudd-Martin, PhD, RN    859-494-7073    Gia.Mudd@uky.edu   
Contact: Rosa Martin    859-323-4305    Rosa.Martin@uky.edu   
Sponsors and Collaborators
University of Kentucky
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Gia Mudd-Martin, PhD, RN University of Kentucky
Study Director: Rosa Martin University of Kentucky

Responsible Party: Gia Mudd, Sponsor/Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03196024     History of Changes
Other Study ID Numbers: 1R01NR016262-01A1 ( U.S. NIH Grant/Contract )
1R01NR016262-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gia Mudd, University of Kentucky:
Diabetes; CVD; Lifestyle; Hispanic; Promotora
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Risk Reduction Behavior
Hispanic Americans; Latinos
Community Health Workers

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases