Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
Public ClinicalTrials.gov record NCT01245686. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity. Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins). The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions. Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.
Study identification
- NCT ID
- NCT01245686
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 489 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2011
- Primary completion
- Jun 30, 2012
- Completion
- Oct 31, 2012
- Last update posted
- Feb 5, 2013
2011 – 2012
United States locations
- U.S. sites
- 5
- U.S. states
- 1
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Durham Family Practice | Durham | North Carolina | 27704 | — |
| Dayspring Family Medicine | Eden | North Carolina | 27288 | — |
| Cabarrus Family Medicine Residency | Kannapolis | North Carolina | 28081 | — |
| Moncure Community Health Center | Moncure | North Carolina | 27559 | — |
| Caswell Family Medical Clinic | Yanceyville | North Carolina | 27379 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01245686, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 5, 2013 · Synced Sep 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01245686 live on ClinicalTrials.gov.