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South Asian Healthy Lifestyle Initiative (SAHELI) for Cardiovascular Risk (SAHELI Trial)

N/A

Waitlist Available

Led By Namratha Kandula, MD,MPH

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SAHELI Trial Summary

This trial is testing a culturally tailored, community-based lifestyle intervention to reduce cardiovascular disease risk in South Asians living in the United States.

SAHELI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participants who receive SAHELI intervention may show greater reduction in clinical risk factors for cardiovascular disease compared to the control group.

SAHELI Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SAHELI InterventionExperimental Treatment1 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.

Group II: Print Health EducationActive Control1 Intervention

Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

South Asian Healthy Lifestyle Initiative (SAHELI)

2018

N/A

~550

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Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,431 Total Patients Enrolled

3 Trials studying Cardiovascular Risk

226 Patients Enrolled for Cardiovascular Risk

NorthShore University HealthSystemOTHER

132 Previous Clinical Trials

737,108 Total Patients Enrolled

Shirley Ryan AbilityLabOTHER

194 Previous Clinical Trials

16,362 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals aged 55 and above accepted in this investigational program?

"In line with the requirements for potential participants, this study only allows persons between 18 and 65 years old to enroll."

Answered by AI

Are researchers still welcoming participants for this research effort?

"Per the information hosted on clinicaltrials.gov, this trial is not actively recruiting participants at present; it was initially published in March of 2018 and last revised October 18th 2022. Despite being inactive, there are 82 additional studies that require patient involvement immediately."

Answered by AI

To whom does this clinical trial apply?

"This trial seeks to enroll 550 subjects aged 18-65 with a BMI of 25 or greater and at least one CVD risk factor such as hypertension, abnormal cholesterol levels, pre-diabetes/diabetes; OR those with a BMI 23-24.9 and at least one clinical risk factor for cardiovascular disease, who are also South Asian adults living within the 22 square mile study area."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

The South Asian Healthy Lifestyle Intervention (SAHELI) Trial: Protocol for a Mixed-methods, Hybrid Effectiveness Implementation Trial for Reducing Cardiovascular Risk in South Asians in the United States

Kandula, Namratha R., Veronica Bernard, Swapna Dave, Linda Ehrlich-Jones, Catherine Counard, Nirav Shah, Santosh Kumar, et al.. 2020. “The South Asian Healthy Lifestyle Intervention (SAHELI) Trial: Protocol for a Mixed-methods, Hybrid Effectiveness Implementation Trial for Reducing Cardiovascular Risk in South Asians in the United States”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2020.105995.

clinicaltrials.govStudy

South Asian Healthy Lifestyle Initiative (SAHELI)

Namratha Kandula 2018. "South Asian Healthy Lifestyle Initiative (SAHELI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03336255.