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Life sciences · Interventional Study
ClinicalTrials.gov · November 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05461495). This is a study registration, not published results. Lead sponsor: New York University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Dementia Caregivers, Diabetes, Heart Disease, Overweight. Interventions: BEHAVIORAL: Treatment Group. Primary outcome measures: Depressive symptoms , 12 months; Self-rated Health , 12 months; Caregiving related stress , 12 months; Positive aspects of caregiving , 12 months; Stigma , 12 months; Chronic disease self management behaviors , 12 months; Loneliness , 12 months; Social support , 12 months; Diabetes , 12 months; Lipid metabolism , 12 months; Inflammation , 12 months; Hypertension , 12 months; Body Mass index (BMI) , 12 months; Waist circumference , 12 months; Care recipient's cognitive impairment , 12 months. Brief summary: This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk/other social media apps \[popular social media apps for individuals of Chinese or Korean descents\] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin, BMI) and inflammation (hsCRP, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.