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South Asian Healthy Lifestyle Initiative (SAHELI) (SAHELI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03336255
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
Metropolitan Asian Family Services
Skokie Health Department
NorthShore University HealthSystem
Case Western Reserve University
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
Namratha Kandula, Northwestern University

Brief Summary:
Research show that South Asians (SA) have a high burden of Cardio Vascular Disease (CVD) risk factors of which, poor diet and physical inactivity remain the major lifestyle risk factors in SA. Intensive diet and physical activity behavioral interventions have been shown to yield improvements across a variety of intermediate cardiovascular health outcomes (blood pressure, cholesterol, glycated hemoglobin, weight) in persons with CVD risk factors and are recommended by national guidelines. However, the investigators prior research found that existing interventions are not reaching SA. First, the usual framing of behavioral risk factor interventions in terms of the biomedical model of CVD is mismatched to SA explanatory models, which emphasize psychosocial causes of CVD. Next, few interventions are tailored to the sociocultural patterns shared by much of the SA community. Interventions that address the individual and shared sociocultural drivers of CVD risk are needed to maximize reach and effectiveness in the high risk and rapidly growing SA population. The proposed study builds on the strong foundation of the South Asian Healthy Lifestyle Initiative (SAHELI), which has a 9-year history of using community-based participatory research to design and test culturally tailored, community-based interventions to reduce CVD disparities in SA. To date, SAHELI has engaged multi-sectoral partners, established relationships of trust, and defined mutually beneficial goals. The investigators also culturally adapted the SAHELI lifestyle intervention to (a) address the individual and sociocultural determinants of CVD risk in SA; and (b) increase components of self-regulation (motivation, self-monitoring, goal setting) that are most effective in eliciting diet and physical activity changes.Hence, the SAHELI intervention integrates evidence-based behavior change techniques with the shared the sociocultural processes salient to SA. A pilot study (n=63) established feasibility of the SAHELI intervention, had a 100% retention rate, and reduced glycated hemoglobin and weight among intervention participants compared to a control group. Based on this preliminary evidence of efficacy and a process evaluation, the investigators modified select components of the intervention for the proposed trial. Study team increased the intervention contact hours, piloted additional diet and exercise content, and included family. The proposed study will use a hybrid trial type 1 design to evaluate the clinical effectiveness and implementation potential of the culturally tailored, community-based lifestyle intervention in a larger, more generalizable at-risk SA population. Study team is uniquely positioned to fill a critical gap in work (a) demonstrating the cultural adaptation of evidence-based lifestyle interventions, and (b) evaluating the effectiveness of the SAHELI intervention in reducing CVD risk in SA living in the U.S.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Behavioral: South Asian Healthy Lifestyle Initiative (SAHELI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • South Asian adults (18-65 years)
  • Living within the 22 square mile study area
  • Ability to understand Hindi, Urdu, Gujarati or English. AND

Body Mass Index of 25 and over and a diagnosis by a doctor of high cholesterol or pre-diabetes/Diabetes, or High blood pressure. OR Body Mass Index of 23 to 24.9 and one clinical risk factors for Cardiovascular Disease (CVD) (CVD risk factors are: Hypertension (Systolic blood pressure >130 or diastolic blood pressure > 80), abnormal cholesterol (Total cholesterol ≥200, triglycerides >150),pre-diabetes (A1c between 5.7-6.4%), or diabetes (A1c 6.5 to 10.9),

Exclusion Criteria:

  • History of a CVD event (stroke or heart attack)
  • Being on insulin
  • Blood pressure ≥180/100 mmHg
  • HbA1c ≥11% BMI ≥ 40
  • Current pregnancy
  • Being ≤ 12 months postpartum
  • Any underlying diseases likely to limit lifespan and/or affects ability to exercise.

Information from the National Library of Medicine

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


Contacts
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Contact: Swapna Dave, MPH,MBBS 3125036995 swapna-dave@northwestern.edu

Locations
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United States, Illinois
Northwestern University-Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Swapna Dave, MPH,PMP,MBBS    312-503-6995    swapna-dave@northwestern.edu   
Principal Investigator: Namratha Kandula, MD, MPH         
Sponsors and Collaborators
Northwestern University
Metropolitan Asian Family Services
Skokie Health Department
NorthShore University HealthSystem
Case Western Reserve University
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: Namratha Kandula, MD,MPH Northwestern University
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Responsible Party: Namratha Kandula, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03336255    
Other Study ID Numbers: STU00204939
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No