Cardiovascular DiseasesNCT06567184
Evaluation of the Strong Hearts Urban Program
A study testing Strong Hearts Urban in people with Cardiovascular Diseases, run by Texas A&M University at 2 sites in United States.
Trial summary
The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Strong Hearts Urban
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2023to 9 Aug 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 or older
- Overweight or obese (BMI≥25)
- Less than 150 minutes of moderate physical activity per week
- Black/African American race and/or Hispanic/Latinx ethnicity
Who cannot join
- Pregnancy, or intent to become pregnant during the study duration
- Unable to read and communicate in English
- Planning to participate in another health behavior change program in the next three months
- Unable/unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Dallas Multipurpose Center
Dallas, Texas, 75212
Texas A&M AgriLife Research and Extension Center at Dallas
Dallas, Texas, 75252
About this study
Official title: Pilot Evaluation of the Strong Hearts Program in an Urban Setting
The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with overweight or obesity.
Read the detailed description
Cultural adaptation of effective health behavior interventions holds the potential to improve health behaviors and ultimately health outcomes among underserved populations. The Strong Hearts (SH) Urban Intervention will adapt the existing SH curriculum for delivery in urban Dallas communities to improve weight status and Life's Essential 8 score for ideal cardiovascular health. Despite declines in heart disease mortality in the United States since 2000, it remains the leading cause of mortality in both men and women-accounting for about one-third of all deaths in the U.S. Costs related to cardiovascular disease (CVD) place a substantial financial burden on the health care system, accounting for an estimated $320 billion in 2016. Although most obesity or CVD prevention programs target only the individual level, the US Centers for Disease Control and Prevention recognizes that health is affected by factors at multiple levels: individual (e.g., behaviors, knowledge, attitudes, skills, psychological factors), social (e.g., influences from one's social network on health-related behaviors), and environmental (e.g., safe places to walk, food choices at workplaces, availability of affordable fruits and vegetables), and recommends integrating approaches to make changes beyond the individual level to support long-term, sustainable behavior change. Providing individuals with the motivation, skills, and opportunity to change behaviors may be less effective if their social or community environment makes it difficult to adopt or maintain these behaviors
SH is a multilevel, multicomponent community-based program, in which an experiential learning focus is combined with social and environmental components, including civic engagement activities related to local resource awareness and enhancement. There is limited knowledge about how programs and services can move beyond commonly used individual-level approaches, which have limitations in terms of cost, impact, reach, and sustainability, to effectively reduce CVD health disparities using an integrated, multi-level, community-engaged approach. This pilot study will provide needed data on the feasibility and preliminary effectiveness of such approaches in urban and underserved communities.
- Conditions
- Cardiovascular Diseases
- Being tested
- Strong Hearts Urban
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strong Hearts UrbanBehavioural
A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities
| Study group | Role | What they receive |
|---|---|---|
| Strong Hearts Urban | Experimental | A 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities Receives: Behavioral: Strong Hearts Urban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Change in body weight
Measured: 12 weeks
Secondary outcomes (6)
Fruit and Vegetable Consumption
Dermal Carotenoid Score. As measured by Veggie Meter using a participant's index finger, the dermal carotenoid score (0-800) reflects a concentration biomarker of fruit and vegetable intake, where a higher score is correlated with higher intake.
Measured: 12 weeks
Self-reported healthy eating behaviors
Healthy Eating Index (HEI) as measured by Dietary Health Questionnaire (DHQ-III). The DHQ-III is a self-administered, web-based food frequency questionnaire scored 0 to 100, where higher scores indicate closer adherence to the Dietary Guidelines for Americans.
Measured: 12 weeks
Physical activity - Active Minutes
Objectively measured physical activity by Fitbit activity tracker, counted as Active Minutes
Measured: 12 weeks
Physical activity - Steps
Objectively measured physical activity by Fitbit activity tracker, counted as steps
Measured: 12 weeks
Participant Acceptability
Participant feedback from follow-up questionnaires measures acceptability on a 5-point Likert scale, where higher score indicates higher satisfaction
Measured: 12 weeks
Intervention Engagement
Engagement is assessed by attendance at study activities including intervention classes and data collection appointments
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start5 Jan 2023
- Primary completion29 Jul 2023
- Study completion9 Aug 2023
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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad D Rethorst, Ph.D., Principal investigator, Texas A&M AgriLife Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567184
- Sponsor's protocol ID
- IRB2022-0801D
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 22 Aug 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Strong Hearts Program in an Urban Setting
- ClinicalTrials.gov ID
- NCT06567184
- Acronym / sponsor ID
- IRB2022-0801D
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 22 Aug 2024 (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 aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with overweight or obesity.
Detailed description
Cultural adaptation of effective health behavior interventions holds the potential to improve health behaviors and ultimately health outcomes among underserved populations. The Strong Hearts (SH) Urban Intervention will adapt the existing SH curriculum for delivery in urban Dallas communities to improve weight status and Life's Essential 8 score for ideal cardiovascular health. Despite declines in heart disease mortality in the United States since 2000, it remains the leading cause of mortality in both men and women-accounting for about one-third of all deaths in the U.S. Costs related to cardiovascular disease (CVD) place a substantial financial burden on the health care system, accounting for an estimated $320 billion in 2016. Although most obesity or CVD prevention programs target only the individual level, the US Centers for Disease Control and Prevention recognizes that health is affected by factors at multiple levels: individual (e.g., behaviors, knowledge, attitudes, skills, psychological factors), social (e.g., influences from one's social network on health-related behaviors), and environmental (e.g., safe places to walk, food choices at workplaces, availability of affordable fruits and vegetables), and recommends integrating approaches to make changes beyond the individual level to support long-term, sustainable behavior change. Providing individuals with the motivation, skills, and opportunity to change behaviors may be less effective if their social or community environment makes it difficult to adopt or maintain these behaviors
SH is a multilevel, multicomponent community-based program, in which an experiential learning focus is combined with social and environmental components, including civic engagement activities related to local resource awareness and enhancement. There is limited knowledge about how programs and services can move beyond commonly used individual-level approaches, which have limitations in terms of cost, impact, reach, and sustainability, to effectively reduce CVD health disparities using an integrated, multi-level, community-engaged approach. This pilot study will provide needed data on the feasibility and preliminary effectiveness of such approaches in urban and underserved communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strong Hearts Urban | Experimental | Behavioral: Strong Hearts UrbanA 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 or older
- Overweight or obese (BMI≥25)
- Less than 150 minutes of moderate physical activity per week
- Black/African American race and/or Hispanic/Latinx ethnicity
Key exclusion criteria (4 listed)
- Pregnancy, or intent to become pregnant during the study duration
- Unable to read and communicate in English
- Planning to participate in another health behavior change program in the next three months
- Unable/unwilling to provide informed consent
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 |
|---|---|---|
| Strong Hearts UrbanA 12-week multi-level intervention targeting behavior modification, nutrition education, strength training, aerobic exercise, and stress reduction activities | Behavioural | Strong Hearts Urban |
Primary outcome
Body Weight
Time frame: 12 weeks
Change in body weight
6 secondary outcomes
Fruit and Vegetable Consumption
Time frame: 12 weeks
Self-reported healthy eating behaviors
Time frame: 12 weeks
Physical activity - Active Minutes
Time frame: 12 weeks
Physical activity - Steps
Time frame: 12 weeks
Participant Acceptability
Time frame: 12 weeks
Intervention Engagement
Time frame: 12 weeks
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 22 Aug 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.
Chad D Rethorst, Ph.D. principal investigator
Texas A&M AgriLife Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strong Hearts Urban in people with Cardiovascular Diseases, run by Texas A&M University at 2 sites 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 4 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: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Body Weight (time frame: 12 weeks). 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 22 Aug 2024.