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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.

ABSTRACT: Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.

SUBMITTER: Kandula NR

PROVIDER: S-EPMC8011000 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Objective:The purpose of this study was to develop and test the feasibility of a culturally tailored Diabetes Prevention Programme (DPP) for US South Asians, a large population with high diabetes risk. Design:The South Asian Health and Prevention Education (SHAPE) study included: (1) focus group discussions with South Asian adults to understand views of lifestyle behaviours and diabetes prevention; (2) modification of the US DPP for South Asians and (3) a pilot, pre-post study to test the feasibility and impact of delivering the culturally tailored programme. Setting:The study was conducted in Atlanta, Georgia, USA. Focus group discussions and intervention classes were held at locations within the community (eg, South Asian restaurants, a public library, university classrooms, a South Asian owned physical therapy studio). Participants:The focus group discussions (n=17 with 109 individuals) included adults aged 25 years of older who self-identified as South Asian. Groups were stratified by age (25-40 years or older than 40 years) and sex. The SHAPE pilot study included 17 (76.5% male with a mean age of 46.9±12 years) South Asian adults aged 25 years or older with pre-diabetes and body mass index (BMI) >22 kg/m2. Results:Formative data from 17 focus group discussions and a community board guided the modification of the DPP curriculum to reflect cultural food preferences and include tools to leverage social support, create a stronger foundation in exercise and overcome culturally specific barriers. The SHAPE pilot study included 17 South Asian adults with pre-diabetes and BMI >22 kg/m2. There were positive changes in participants' weight, waist circumference, blood pressure, plasma lipids, HbA1c and other cardiometabolic markers postintervention and 55% of participants regressed to normoglycaemia. Conclusion:These results provide important information on the barriers faced by US South Asians in participating in 'standard' lifestyle change programs, indicate the feasibility of culturally tailored programmes and show positive impact of a culturally tailored programme for diabetes prevention in the South Asian population.

Project description:To explore the reasons for enrolling, experiences of participating and reasons for remaining in a family-based, cluster randomised controlled trial of a dietitian-delivered lifestyle modification intervention aiming to reduce obesity in South Asians at high risk of developing diabetes.Qualitative study using narrative interviews of a purposive sample of trial participants following completion of the intervention. Data were thematically analysed.The intervention was conducted in Scotland and resulted in a modest decrease in weight, but did not statistically reduce the incidence of diabetes.We conducted 21 narrative interviews with 24 participants (20 trial participants and four family volunteers).Many participants were motivated to participate because of: known family history of diabetes and the desire to better understand diabetes-related risks to their own and their family's health; ways to mitigate these risks and to benefit from personalised monitoring. Home-based interventions, communication in the participant's chosen language(s) and continuity in dietitians supported their continuing engagement with the trial. Adaptations in food choices were initially accommodated by participants, although social and faith-based responsibilities were reported as important barriers to persevering with agreed dietary goals. Many participants reported that increasing their level of physical activity was difficult given their long working hours, physically demanding employment and domestic commitments; this being compounded by Scotland's challenging climate and a related reluctance to exercise in the outdoors.Although participants had strong personal interests in participation and found the information provided by dietitians useful, they nonetheless struggled to incorporate the dietary and exercise recommendations into their daily lives. In particular, increasing levels of physical exercise was described as an additional and in some cases unachievable burden. Consideration needs to be given to strengthening and supporting lifestyle interventions with community-based approaches in order to help overcome wider social and environmental factors.

Project description:BACKGROUND:This paper describes the design and methods of a multi-phase study to reduce early childhood caries and obesity in vulnerable South Asian (SA) immigrants in the United States. Early childhood caries and obesity are the most common diseases of early childhood. Risk factors for both diseases are rooted in early childhood feeding practices such as bottle feeding and intake of sweets and sweetened beverages. The Common Health/Risk Factor Approach to addressing oral health is widely promoted by the WHO and other policy makers. This approach recognizes links between oral health and other diseases of modernity. Our CHALO! ("Child Health Action to Lower Obesity and Oral health risk"--from a Hindi word meaning "Let's go!") study targets SA families at high risk for early childhood caries and obesity. CHALO! addresses common risk factors associated with these two common diseases of childhood. METHODS:This two part project includes a randomized controlled trial, and a Knowledge Translation campaign. A randomized controlled trial will enroll n?=? 360 families from pediatric practices serving South Asians in the New York metro area. The intervention group will receive home visits by SA community health workers at 6, 8, 10, 12, 14, and 16 months of age. Controls will receive culturally tailored educational material. Primary outcomes-- cariogenic and obesogenic feeding practices at 6, 12, and 18 months-- will be assessed with the MySmileBuddy iPad based tool. Secondary outcomes include: oral hygiene practices, anthropometrics, and caries incidence at 18 months. A public education campaign will focus on both families and health care providers. DISCUSSION:There are few Common Health/Risk Factor Approach published studies on obesity and oral health risk in children, despite health morbidity and costs associated with both conditions. CHALO! comprises a multi-level interventions designed to promote culturally competent, sustainable change. TRIAL REGISTRATION:ClinicalTrials.gov NCT03077425 .

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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.

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