South Asian Healthy Lifestyle Initiative (SAHELI)
Condition: Cardiovascular Risk Factor
Study type: Interventional

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.
    


Intervention name(s): South Asian Healthy Lifestyle Initiative (SAHELI)
Intervention type(s): Behavioral
Intervention description(s): Culturally tailored lifestyle intervention for South Asians.
Other intervention name(s): SAHELI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention