South Asian Healthy Lifestyle Initiative (SAHELI) (SAHELI)
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|ClinicalTrials.gov Identifier: NCT03336255|
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factor||Behavioral: South Asian Healthy Lifestyle Initiative (SAHELI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Community Translation of the South Asian Healthy Lifestyle Intervention|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
No Intervention: Print Health Education
Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Experimental: SAHELI Intervention
Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 16 to 20 participants who will attend 16 weekly, 90 minute group education sessions at Metropolitan Asian Family Services or Skokie Health Department. 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.
Behavioral: South Asian Healthy Lifestyle Initiative (SAHELI)
Culturally tailored lifestyle intervention for South Asians.
Other Name: SAHELI
- Participants who receive SAHELI intervention may show greater reduction in clinical risk factors for cardiovascular disease compared to the control group. [ Time Frame: 12 months ]Total of 550 participants with 50% randomized to SAHELI intervention arm will show significantly greater improvements in clinical risk factors associated with Cardio Vascular Disease (primary outcomes of systolic and diastolic blood pressure, cholesterol, glycated hemoglobin, and weight) relative to a comparison group that receives print education materials on healthy lifestyle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336255
|Contact: Swapna Dave, MPH,MBBSfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University-Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Swapna Dave, MPH,PMP,MBBS 312-503-6995 email@example.com|
|Principal Investigator: Namratha Kandula, MD, MPH|
|Principal Investigator:||Namratha Kandula, MD,MPH||Northwestern University|