Risk Reduction BehaviorNCT03196024
Corazon de la Familia (Heart of the Family)
A study testing Family-focused intervention arm and Individual-focused intervention arm in people with Risk Reduction Behavior and Diabetes Mellitus, Type 2, run by Gia Mudd at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior, Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Family-focused intervention arm and Individual-focused intervention arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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;
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky
Lexington, Kentucky, 40536-0232
About this study
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
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.
Read the 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.
- Being tested
- Family-focused intervention arm, Individual-focused intervention arm
- Keywords
- Diabetes; CVD; Lifestyle; Hispanic; Promotora, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Reduction Behavior, Hispanic Americans; Latinos, Community Health Workers
- Medical subject headings
- Risk Reduction Behavior, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-focused intervention armBehavioural
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 armBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Family-focused intervention arm | Experimental | 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. Receives: Behavioral: Family-focused intervention arm |
| Individual-focused intervention arm | Active comparator | 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. Receives: Behavioral: Individual-focused intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI)
BMI based on measurements of weight and height and calculated as kg/m2
Measured: Baseline, 3 months, and 12 months
Change in blood pressure
Blood pressure assessed using calibrated sphygmomanometry
Measured: 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.
Measured: Baseline, 3 months, and 12 months
Change in hemoglobin A1c (HbA1c)
HbA1c measured using point-of-care testing obtained by fingerstick.
Measured: 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
Measured: Baseline, 3 months, and 12 months
Change in diet quality
Diet quality will be measured using the Food Frequency Questionnaire
Measured: Baseline, 3 months, and 12 months
Change in tobacco use
Urine cotinine levels will be used to assess tobacco use
Measured: Baseline, 3 months, and 12 months
Secondary outcomes (1)
Support for healthy behaviors
Self report of experience of social support for healthy behaviors
Measured: Baseline, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start5 Oct 2017
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Mudd
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Gia Mudd, University of Kentucky
- Investigators
- Gia Mudd-Martin, PhD, RN, Principal investigator, University of KentuckyRosa Martin, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196024
- Sponsor's protocol ID
- 1R01NR016262-01A1
- Other IDs
- 1R01NR016262-01A1
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03196024
- Acronym / sponsor ID
- 1R01NR016262-01A1
- Keywords
- Diabetes; CVD; Lifestyle; Hispanic; Promotora, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Reduction Behavior, Hispanic Americans; Latinos, Community Health Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Gia MuddUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family-focused intervention arm | Experimental | Behavioral: Family-focused intervention armFamily-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 | Active comparator | Behavioral: Individual-focused intervention armIndividual-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- 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:
Key exclusion criteria (8 listed)
- 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.
- Have known coronary artery or cerebrovascular disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-focused intervention armFamily 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. | Behavioural | Family-focused intervention arm |
| Individual-focused intervention armFamily 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. | Behavioural | Individual-focused intervention arm |
Primary outcome
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
Change in blood pressure
Time frame: Baseline, 3 months, and 12 months
Blood pressure assessed using calibrated sphygmomanometry
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.
Change in hemoglobin A1c (HbA1c)
Time frame: Baseline, 3 months, and 12 months
HbA1c measured using point-of-care testing obtained by fingerstick.
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
Change in diet quality
Time frame: Baseline, 3 months, and 12 months
Diet quality will be measured using the Food Frequency Questionnaire
Change in tobacco use
Time frame: Baseline, 3 months, and 12 months
Urine cotinine levels will be used to assess tobacco use
1 secondary outcome
Support for healthy behaviors
Time frame: Baseline, 3 months, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gia Mudd-Martin, PhD, RN principal investigator
University of Kentucky
Rosa Martin study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-focused intervention arm and Individual-focused intervention arm in people with Risk Reduction Behavior and Diabetes Mellitus, Type 2, run by Gia Mudd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) (time frame: Baseline, 3 months, and 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.