Translating a Heart Disease Lifestyle Intervention Into the Community
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 19, 2012 | ||||||||
| Last Updated Date | April 15, 2013 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01647438 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Translating a Heart Disease Lifestyle Intervention Into the Community | ||||||||
| Official Title ICMJE | Translating a Heart Disease Lifestyle Intervention Into the Community | ||||||||
| Brief Summary | Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved South Asian ((Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 30 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01647438 | ||||||||
| Other Study ID Numbers ICMJE | R21 HL113743-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Namratha Kandula, Northwestern University | ||||||||
| Study Sponsor ICMJE | Northwestern University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Northwestern University | ||||||||
| Verification Date | April 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||