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Cardiovascular Risk FactorSAHELINCT03336255

South Asian Healthy Lifestyle Initiative (SAHELI)

A study testing South Asian Healthy Lifestyle Initiative (SAHELI) in people with Cardiovascular Risk Factor, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Risk Factor
What is being tested?
South Asian Healthy Lifestyle Initiative (SAHELI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
1 siteUnited States
Study dates
15 Mar 2018to 24 Feb 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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),

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Community Translation of the South Asian Healthy Lifestyle Intervention

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.

Being tested
South Asian Healthy Lifestyle Initiative (SAHELI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • South Asian Healthy Lifestyle Initiative (SAHELI)Behavioural

    Also called SAHELI

    Culturally tailored lifestyle intervention for South Asians.

Study groups in NCT03336255
Study groupRoleWhat they receive
Print Health EducationNo interventionParticipants will receive primary care referrals and print health education material about heart disease prevention in the mail.
SAHELI InterventionExperimentalParticipants 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.
Receives: Behavioral: South Asian Healthy Lifestyle Initiative (SAHELI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight

    Change in weight in kg between baseline and 12 months

    Measured: 12 months

  2. Change in Systolic Blood Pressure

    Change in systolic blood pressure in mmHG between baseline and 12 months

    Measured: 12 months

  3. Change in Diastolic Blood Pressure

    Change in diastolic blood pressure in mm HG between baseline and 12 months

    Measured: 12 months

  4. Change in Total Cholesterol

    Change in total cholesterol in mg/dL between baseline and 12 months

    Measured: 12 months

  5. Change in HbA1c

    Percent change in HbA1c between baseline and 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start15 Mar 2018
  3. Primary completion11 Feb 2023
  4. Study completion24 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336255
Sponsor's protocol ID
STU00204939
Other IDs
R01HL132978
Acronym
SAHELI
Status last verified
Jun 2026
First submitted
19 Oct 2017
Last updated
15 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lam EL, Kandula NR, Shah NS. The Role of Family Social Networks in Cardiovascular Health Behaviors Among Asian Americans, Native Hawaiians, and Pacific Islanders. J Racial Ethn Health Disparities. 2023 Oct;10(5):2588-2599. doi: 10.1007/s40615-022-01438-9. Epub 2022 Nov 3.

    PubMed 36329308

  • Vu M, Nedunchezhian S, Lancki N, Spring B, Brown CH, Kandula NR. A mixed-methods, theory-driven assessment of the sustainability of a multi-sectoral preventive intervention for South Asian Americans at risk for cardiovascular disease. Implement Sci Commun. 2024 Sep 13;5(1):89. doi: 10.1186/s43058-024-00626-4.

    PubMed 39267181

  • Kandula NR, Shah NS, Kumar S, Charley M, Clauson M, Lancki N, Finch EA, Ehrlich-Jones L, Rao G, Spring B, Shah NS, Siddique J. Culturally Adapted Lifestyle Intervention for South Asian Adults With Cardiovascular Risk Factors: The SAHELI Randomized Clinical Trial. JAMA Cardiol. 2024 Nov 1;9(11):973-981. doi: 10.1001/jamacardio.2024.2526.

    PubMed 39259546

  • 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.

    PubMed 32220632

Questions about this trial

What is this clinical trial studying?

A study testing South Asian Healthy Lifestyle Initiative (SAHELI) in people with Cardiovascular Risk Factor, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336255, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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