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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.
South Asian individuals were recruited from a community based organization in Chicago and randomly assigned to the print health education group or the SAHELI intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Print Health Education | Other | Participants receive print health education materials |
|
| Lifestyle Intervention | Experimental | Six weekly health education classes and phone counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention | Behavioral | Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity (Minutes/Week) | Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months. | baseline and 6-months |
| Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake | Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months | baseline and 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Namratha Kandula, MD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University-Feinberg School of Medicine | Chicago | Illinois | 60611 | United States | ||
| Metropolitan Asian Family Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27225217 | Derived | Jayaprakash M, Puri-Taneja A, Kandula NR, Bharucha H, Kumar S, Dave SS. Qualitative Process Evaluation of a Community-Based Culturally Tailored Lifestyle Intervention for Underserved South Asians. Health Promot Pract. 2016 Nov;17(6):802-813. doi: 10.1177/1524839916650165. Epub 2016 May 24. | |
| 26475629 | Derived | Kandula NR, Dave S, De Chavez PJ, Bharucha H, Patel Y, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. Translating a heart disease lifestyle intervention into the community: the South Asian Heart Lifestyle Intervention (SAHELI) study; a randomized control trial. BMC Public Health. 2015 Oct 16;15:1064. doi: 10.1186/s12889-015-2401-2. |
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Community outreach
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Care Referral and Print Health Education | Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail. |
| FG001 | Lifestyle Intervention | Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Care Referral and Print Health Education | Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail. |
| BG001 | Lifestyle Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Physical Activity (Minutes/Week) | Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months. | Posted | Mean | Standard Error | min/week | baseline and 6-months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Care Referral and Print Health Education | Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Namratha Kandula, Principal Investigator | Northwestern University | 312-503-6470 | nkandula@nm.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| D018149 | Glucose Intolerance |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Print Health Education | Other | Participants will receive primary care referrals and print health education material about heart disease prevention in the mail. |
|
| Chicago |
| Illinois |
| 60645 |
| United States |
| 24060673 | Derived | Kandula NR, Patel Y, Dave S, Seguil P, Kumar S, Baker DW, Spring B, Siddique J. The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: design and methods. Contemp Clin Trials. 2013 Nov;36(2):479-87. doi: 10.1016/j.cct.2013.09.007. Epub 2013 Sep 21. |
Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake | Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months | Posted | Mean | Standard Error | percentage of kilocalories | baseline and 6-months |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Lifestyle Intervention | Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives. | 0 | 31 | 0 | 31 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |