Group 1 (Intervention) for Heart Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mexia, Mexia, TX
Heart Diseases
Group 1 (Intervention) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a civic engagement curriculum can improve healthy eating and physical activity habits in residents.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Heart Diseases

Study Objectives

This trial is evaluating whether Group 1 (Intervention) will improve 2 primary outcomes and 55 secondary outcomes in patients with Heart Diseases. Measurement will happen over the course of Baseline to 24 months.

Baseline to 24 months
Change in (community) social cohesion
Change in American Heart Association's Life's Simple 7 (LS7) cardiovascular health score
Change in HDL cholesterol
Change in LDL cholesterol
Change in Simple 7 cardiovascular health score
Change in World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) recommendation adherence score
Change in alcohol consumption
Change in body mass index (BMI)
Change in community connection
Change in community membership
Change in confidence for healthy eating
Change in confidence for healthy eating (expanded)
Change in consumption of whole grains
Change in diastolic blood pressure
Change in exercise attitudes
Change in exercise confidence
Change in fasting blood glucose
Change in fiber intake
Change in frequency of consuming ultra-processed foods
Change in fresh fruit and vegetable availability
Change in fruit and vegetable intake
Change in general civic engagement attitudes
Change in general civic engagement behaviors
Change in general health status
Change in healthy eating motivation
Change in individual mobilization
Change in investment in community health
Change in mindset and expectations
Change in neighborhood aesthetic
Change in neighborhood safety
Change in red and processed meat consumption
Change in restaurant access
Change in restaurant healthy food availability
Change in resting heart rate
Change in sedentary behavior
Change in social (group) identity
Change in social engagement
Change in social issues advocacy
Change in social support for healthy eating
Change in social support for healthy eating scale
Change in social support for physical activity
Change in store access
Change in store selection motivation
Change in systolic blood pressure
Change in total HEI score
Change in total cholesterol
Change in total dietary quality score
Change in total physical activity
Change in total steps per day
Change in triglycerides
Change in waist circumference
Change in walking environment
Current smoker (y/n)
Met recommendation for fish consumption (y/n)
Percent with diabetes/prediabetes
Percent with high/borderline high cholesterol.
Percent with high/elevated blood pressure

Trial Safety

Safety Progress

1 of 3

Other trials for Heart Diseases

Trial Design

2 Treatment Groups

Group 1 (Intervention)
1 of 2
Group 2 (Control)
1 of 2
Experimental Treatment

This trial requires 2260 total participants across 2 different treatment groups

This trial involves 2 different treatments. Group 1 (Intervention) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Group 1 (Intervention)
Behavioral
For Change Club members (CCM) only: CCM will participate in meetings of the Change Club and continue implementation of a change to the community environment for up to an additional 24 months. Change Club members will also be asked to recruit 10 or more friends and family members (FFM) to participate in the research study. In addition, 100 community residents (CR) will be recruited into the study. Family members, friends and community residents do not participate in the Change Club, but may hear about Change Club activities in their community.
Group 2 (Control)
Behavioral
Control group participants will participate in no intervention activities during the 3-year research study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Group 1 (Intervention)
2017
N/A
~190

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 24 months for reporting.

Closest Location

Mexia - Mexia, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We will be recruiting members of Change Club, friend and family members of Change Club, and community residents. show original
Age 18-99
English-speaking
Provide consent electronically
Be willing to be randomized to either group
Score "poor" or "intermediate" on at least one of the Simple 7 composite score items (e.g. not meeting Physical Activity Guidelines for Americans)
Live in one of the designated towns in NY and TX
You have a family member or friend identified by a CCM. show original

Patient Q&A Section

Can heart diseases be cured?

"Findings from a recent study, even using a higher threshold for a positive test result, heart disease could not be fully cured. For one person with heart disease, one negative test result per person does not change their cardiovascular outcomes substantially." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart diseases?

"Symptoms of heart disease in children are common. In younger children a heart murmur is the most common sign. The signs of heart murmur also vary according to the type and severity of heart disease and the age of the child." - Anonymous Online Contributor

Unverified Answer

What is heart diseases?

"Heart diseases is a disease of the blood vessels. It could cause blood vessels to narrow, restricting the blood flowing to the body, creating an increased pressure on the heart and eventually leading to heart pain.Heart diseases in other words could trigger heart attacks. Symptoms of heart attacks depend on the location of the affected heart part:\n\n- Heart attack: the most prominent symptom associated heart attacks are pressure in the chest, chest pain, sweating and shortness of breath.\n- Heart failure: would mean the disease of the heart that affects in the left ventricle, which pumps blood to the body. Symptoms related to heart failure are dizziness, fainting and shortness of breath." - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart diseases?

"Antipsychotics are sometimes prescribed for individuals with various heart conditions or comorbid disorders like bipolar disorder or schizophrenia. It helps to treat symptoms but its benefit is unclear as it doesn't seem to be effective and there is potential for side effects such as extrapyramidal syndrome. Other medications are commonly prescribed such as ACE inhibitors or calcium channel blockers. Also, cholesterol is often addressed for people with heart disease by taking cholesterol blockers or lipid-lowering drugs. These can be prescribed as a single tablet. In some cases, an individual might need to start a combination therapy due to intolerance or toxicity of other drugs. Other treatment modalities (that are rarely prescribed) are massage, acupuncture and electroacupuncture." - Anonymous Online Contributor

Unverified Answer

What causes heart diseases?

"While the main cause of heart diseases remains to be cardiovascular disease, people in many high-risk populations are at risk for heart diseases as a result of chronic inflammation." - Anonymous Online Contributor

Unverified Answer

How many people get heart diseases a year in the United States?

"The number of adults having an initial coronary or major vascular surgery has been growing rapidly in the United States for 15 years, with numbers reaching almost 2 million annually in 2013 in the United States alone. The current data imply that one in 8 adults will be diagnosed with one of these heart diseases within their lifetimes." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in group 1 (intervention) for therapeutic use?

"The most recent papers from the ITHC discuss recent developments in the management of CHD in those of advanced age. Many papers have been published over the last decade regarding therapeutic use for CHD in G/G1 for over 10 years; several randomized controlled trials have been performed in subjects diagnosed with advanced CHD. These trials have demonstrated the success of these therapeutic approaches to improve the health status and survival of patients with advanced CHD. Although some of the therapeutic uses have been evaluated in G/G1 with significant benefit in the reduction of the number of hospitalizations and rehospitalizations for the primary prevention of acute decompensation, the number of hospitalization due to CHF and the need for cardiac transplantation were not reduced." - Anonymous Online Contributor

Unverified Answer

Is group 1 (intervention) typically used in combination with any other treatments?

"Group 1, in combination with any other treatments for primary prevention of coronary heart disease, significantly reduced total and cardiovascular mortality in both sexes, despite a significant decrease in absolute event rates within this group." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of heart diseases?

"Risk factors associated with heart disease are shared by various types of heart disease and are the result of both genetic and environmental effects. Many of the risk factors are treatable. As cardiac diseases become more common in young adults, early prevention and detection are important." - Anonymous Online Contributor

Unverified Answer

Does heart diseases run in families?

"Heart is a genetic disease. Recent findings, it seems that first-degree relatives of patients with familial and non-familial CAD show significantly different profile among their lipid profile, as well, their blood pressure." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets heart diseases?

"The lifetime risk of heart disease is low among those who are between 65 and 89 years old, but becomes higher when the life expectancy drops below 65 years. It is estimated that about 6% of the population over 65 years have heart disease, which may be underestimated by age-adjusted prevalence." - Anonymous Online Contributor

Unverified Answer

Has group 1 (intervention) proven to be more effective than a placebo?

"There seemed to be an effect of the intervention on the quality of life irrespective of treatment-group composition (placebo, active) and the treatment-group composition showed no significant effect on the change from baseline to follow-up, therefore this study suggests that we are unlikely to verify the positive results of a previous meta-analysis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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