South Asian Healthy Lifestyle Initiative (SAHELI)

Cardiovascular Risk Factor Clinical Trial

— SAHELI  

Official title:

Community Translation of the South Asian Healthy Lifestyle Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336255
• Other study ID #: STU00204939
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: February 24, 2023

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research show that South Asians (SA) have a high burden of Cardiovascular 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. The proposed study is based on the pilot study and 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: February 24, 2023
• Est. primary completion date: February 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Behavioral:
• South Asian Healthy Lifestyle Initiative (SAHELI)
Culturally tailored lifestyle intervention for South Asians.

Locations

Country	Name	City	State
United States	Northwestern University-Feinberg School of Medicine	Chicago	Illinois

Sponsors (6)

Lead Sponsor	Collaborator
Northwestern University	Case Western Reserve University, Metropolitan Asian Family Services, NorthShore University HealthSystem, Shirley Ryan AbilityLab, Skokie Health Department

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kandula NR, Bernard V, Dave S, Ehrlich-Jones L, Counard C, Shah N, Kumar S, Rao G, Ackermann R, Spring B, Siddique J. 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. Contemp Clin Trials. 2020 May;92:105995. doi: 10.1016/j.cct.2020.105995. Epub 2020 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants who receive SAHELI intervention may show greater reduction in clinical risk factors for cardiovascular disease compared to the control group.	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.	12 months