Cardiovascular DiseasesNCT05322876
Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
A study testing Healthy Hearts Family Program in people with Cardiovascular Diseases and Metabolic Syndrome, run by Poudre Valley Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of a 6-month family-based community intervention to mitigate cardiovascular disease risk factors in Hispanic families in northern Colorado as measured through biometric screenings, body composition, physical activity, and health knowledge. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome
- What is being tested?
- Healthy Hearts Family Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 31 Dec 2024
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least one member of the family unit self-identifies as Hispanic
- At least 13 years of age
Who cannot join
- Unwilling to wear Fitbit devices daily for 6 months except when charging and sleeping
- Cannot read or understand either English or Spanish
- Cannot return to screening location to perform the minimum of the baseline, 3-month and 6-month follow-up screenings
- Children or adolescents will be excluded from this project without a minimum of one accompanying parent or guardian
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80528
NaNet Jenkins, MPH, MHSA, 970-624-5298, nanet.jenkins@uchealth.org
About this study
The purpose of this study is to evaluate the feasibility of a 6-month family-based community intervention to mitigate cardiovascular disease risk factors in Hispanic families in northern Colorado as measured through biometric screenings, body composition, physical activity, and health knowledge.
Read the detailed description
The current project aims to leverage the UCHealth Healthy Hearts Family Program to provide a free, non-insurance-based 1-year cardiovascular disease (CVD) prevention and wellness program to Hispanic Colorado families. This program includes an interactive educational class series, baseline and quarterly biometric screenings, and optional consultations with an Exercise Physiologist and a Dietitian. This program takes a novel approach to preventative care by incorporating the family unit with the intention of having the child be the agent of change. The long-term goals of this project are to significantly improve CVD risk factors among participating families and to disseminate study findings to inform developing and current outreach programs to offer effective CVD prevention programs for Hispanic citizens. This work may ultimately lead to more Hispanics being served through new or existing programs, therefore expanding important preventative community health interventions into this underserved population.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Being tested
- Healthy Hearts Family Program
- Keywords
- Metabolic Syndrome, Cardiovascular Disease Risk Factors, Community Intervention
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Hearts Family ProgramBehavioural
Participants will participate in a baseline health and knowledge screening, followed by a 6-week once-weekly class series, and 3- and 6-month follow-up health and knowledge screenings.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Hearts Family Program | Experimental | Participants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program. Receives: Behavioral: Healthy Hearts Family Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of program through changes in physical health - Daily Steps
Physical activity metrics (daily average steps per month) measured by Fitbit devices
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Physical Activity
Physical activity metrics (daily minutes of light, moderate and vigorous activity per month) measured by Fitbit devices
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Blood Pressure
Biometric variables (blood pressure in mmHg)
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Lab Value -Lipid Profile
Biometric variables - lab values (lipid profile in mg/dL) measured through finger stick blood sampling
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Lab Value - Triglycerides
Biometric variables - lab values ( triglycerides in mg/dL) measured through finger stick blood sampling
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Lab Value - Blood Glucose
Biometric variables - lab values (blood glucose all in mg/dL) measured through finger stick blood sampling
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Waist Circumference
Body composition (waist circumference in inches)
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Body Composition - Muscle Mass
Body composition (muscle mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Body Composition - Fat Mass
Body composition (fat-free mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Body Fat Percentage
Body composition (body fat percentage) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in physical health - Visceral Fat Rating
Body composition (Tanita visceral fat rating) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Measured: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Efficacy of program through changes in health knowledge
Health knowledge gained and retained will be evaluated and compared at baseline, post-6 week class series, 3- and 6-month follow-ups utilizing previously developed and utilized Healthy Hearts knowledge survey. This outcome will be measured by correct responses on the Healthy Hearts knowledge survey.
Measured: Baseline, post-6 week class series, 3- and 6-month follow-up appointments.
Secondary outcomes (3)
Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended
Attendance for screenings, classes and other consultations across baseline and follow-up visits. Attendance will be measured as the percentage of scheduled visits (including the 6 week class series and the 3- and 6-month follow-up visits) completed.
Measured: These variables will be measured and assessed throughout the full 6 month program.
Adherence to program and utilization of additional resources - Fitbit Utilization
Compliance to Fitbit utilization as measured by days worn throughout the 6 month program. The NHANES compliance to wear time of > 10 hours worn per day will be utilized.
Measured: These variables will be measured and assessed throughout the full 6 month program.
Adherence to program and utilization of additional resources - Resource Utilization
Use of Exercise Physiologist and Dietician resources provided will be quantified and reported. This outcome will be reported as the number of consultation appointments requested and utilized throughout the program.
Measured: These variables will be measured and assessed throughout the full 6 month program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start22 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sample
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Fitbit LLC
- Responsible party
- Principal investigator, Gary J. Luckasen, MD, Poudre Valley Health System
- Investigators
- Victoria Bandera, MS, Principal investigator, University of Colorado Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322876
- Sponsor's protocol ID
- HHFP-001
- Status last verified
- Apr 2024
- First submitted
- 25 Feb 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Reducing Cardiovascular Disease Risk Factors in Hispanics Through a Family-Based Community Intervention
- ClinicalTrials.gov ID
- NCT05322876
- Acronym / sponsor ID
- HHFP-001
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Cardiovascular Disease Risk Factors, Community Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Collaborators
- Fitbit LLC
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 2022 (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 purpose of this study is to evaluate the feasibility of a 6-month family-based community intervention to mitigate cardiovascular disease risk factors in Hispanic families in northern Colorado as measured through biometric screenings, body composition, physical activity, and health knowledge.
Detailed description
The current project aims to leverage the UCHealth Healthy Hearts Family Program to provide a free, non-insurance-based 1-year cardiovascular disease (CVD) prevention and wellness program to Hispanic Colorado families. This program includes an interactive educational class series, baseline and quarterly biometric screenings, and optional consultations with an Exercise Physiologist and a Dietitian. This program takes a novel approach to preventative care by incorporating the family unit with the intention of having the child be the agent of change. The long-term goals of this project are to significantly improve CVD risk factors among participating families and to disseminate study findings to inform developing and current outreach programs to offer effective CVD prevention programs for Hispanic citizens. This work may ultimately lead to more Hispanics being served through new or existing programs, therefore expanding important preventative community health interventions into this underserved population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sample
| Arm | Type | Receives |
|---|---|---|
| Healthy Hearts Family Program | Experimental | Behavioral: Healthy Hearts Family ProgramParticipants will be enrolled in the standard Healthy Hearts Family Program 6-month family-based cardiovascular disease prevention program. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- At least one member of the family unit self-identifies as Hispanic
- At least 13 years of age
Key exclusion criteria (4 listed)
- Unwilling to wear Fitbit devices daily for 6 months except when charging and sleeping
- Cannot read or understand either English or Spanish
- Cannot return to screening location to perform the minimum of the baseline, 3-month and 6-month follow-up screenings
- Children or adolescents will be excluded from this project without a minimum of one accompanying parent or guardian
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 |
|---|---|---|
| Healthy Hearts Family ProgramParticipants will participate in a baseline health and knowledge screening, followed by a 6-week once-weekly class series, and 3- and 6-month follow-up health and knowledge screenings. | Behavioural | Healthy Hearts Family Program |
Primary outcome
Efficacy of program through changes in physical health - Daily Steps
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Physical activity metrics (daily average steps per month) measured by Fitbit devices
Efficacy of program through changes in physical health - Physical Activity
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Physical activity metrics (daily minutes of light, moderate and vigorous activity per month) measured by Fitbit devices
Efficacy of program through changes in physical health - Blood Pressure
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Biometric variables (blood pressure in mmHg)
Efficacy of program through changes in physical health - Lab Value -Lipid Profile
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Biometric variables - lab values (lipid profile in mg/dL) measured through finger stick blood sampling
Efficacy of program through changes in physical health - Lab Value - Triglycerides
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Biometric variables - lab values ( triglycerides in mg/dL) measured through finger stick blood sampling
Efficacy of program through changes in physical health - Lab Value - Blood Glucose
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Biometric variables - lab values (blood glucose all in mg/dL) measured through finger stick blood sampling
Efficacy of program through changes in physical health - Waist Circumference
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Body composition (waist circumference in inches)
Efficacy of program through changes in physical health - Body Composition - Muscle Mass
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Body composition (muscle mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Efficacy of program through changes in physical health - Body Composition - Fat Mass
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Body composition (fat-free mass in pounds) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Efficacy of program through changes in physical health - Body Fat Percentage
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Body composition (body fat percentage) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Efficacy of program through changes in physical health - Visceral Fat Rating
Time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared
Body composition (Tanita visceral fat rating) measured with a Tanita MC980Uplus multi-frequency bio-electrical impedance analysis device.
Efficacy of program through changes in health knowledge
Time frame: Baseline, post-6 week class series, 3- and 6-month follow-up appointments.
Health knowledge gained and retained will be evaluated and compared at baseline, post-6 week class series, 3- and 6-month follow-ups utilizing previously developed and utilized Healthy Hearts knowledge survey. This outcome will be measured by correct responses on the Healthy Hearts knowledge survey.
3 secondary outcomes
Adherence to program and utilization of additional resources - Program attendance - Percentage of Scheduled Visits Attended
Time frame: These variables will be measured and assessed throughout the full 6 month program.
Adherence to program and utilization of additional resources - Fitbit Utilization
Time frame: These variables will be measured and assessed throughout the full 6 month program.
Adherence to program and utilization of additional resources - Resource Utilization
Time frame: These variables will be measured and assessed throughout the full 6 month program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Victoria Bandera, MS principal investigator
University of Colorado Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Hearts Family Program in people with Cardiovascular Diseases and Metabolic Syndrome, run by Poudre Valley Health System 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria M Bandera, MS (7329913081, victoria.bandera@uchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of program through changes in physical health - Daily Steps (time frame: Baseline, 3-month follow up and 6-month follow up data will be evaluated and compared). The study lists 12 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 3 Apr 2024.