Please select the eligibility criteria that correspond to the clinical trial below.
Title: Community Translation of the South Asian Healthy Lifestyle Intervention
Brief 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.


Options:
A: Inclusion Criteria:

* 21 years of age and older
* Receiving treatment for diabetes at selected primary care practices throughout New York City
* Most recent HbA1c ≥ 7.5% (max 3 months prior to randomization)
* Ability to speak and read English or Spanish (or someone in the household who will read to them)
* Access to a telephone
* Willing to give informed consent to participate and accept random assignment.

Exclusion Criteria:

* Stated intention to move out of the New York City area during the next year
* Mental incapacity (e.g., confusion) evident on first telephone contact by Department of Health staff
* Treatment provider deems that the patient is inappropriate for the trial
B: Inclusion Criteria:

* At high risk for impending death in the next 12 months

Exclusion Criteria:

* Patient not having decision-making capacity
C: 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.
D: Inclusion Criteria:

* Female gender
* Age 25 through 64 years
* Physical inactivity
* BMI \> 25
* Immigrant to Sweden from either the Middle East or Latin America

Exclusion Criteria:

* Diabetes mellitus type I
* Ischemic heart disease
* Disability that interferes with the ability to participate in lifestyle-related physical activity

Answer: C