Community-Based Social Connection Intervention Program to Improve Cardiovascular and Brain Health

Loneliness and social isolation are increasingly recognized as major public health concerns, particularly among older adults. These conditions are associated with elevated risks of cardiovascular disease, cognitive decline, depression, sleep disturbances, reduced quality of life, and premature mortality. Although evidence from high-income countries supports the use of community-based interventions to enhance social connection, there is limited research in low- and middle-income countries and almost no data from rural Latin American settings. The Social Connection Intervention Program (SCIP) was developed to address this gap by adapting evidence-based strategies to the cultural, social, and resource context of rural Ecuador.

Study Design and Setting: This is a quasi-experimental, longitudinal study conducted in three rural villages in coastal Ecuador that have participated in a population-based cohort for more than 12 years. One community (Atahualpa) will receive the intervention, while two comparable communities (El Tambo and Prosperidad) will serve as comparison sites. Allocation is based on pre-existing community of residence. The study will follow participants for 12 months, with assessments at baseline, 6 months, and 12 months.

Participants: Eligible participants are adults aged 60 years or older who have lived in the community for at least one year, have no plans to relocate, and do not have disability, dementia, stroke, or major psychiatric illness. Written informed consent will be obtained from all participants. Recruitment will leverage the existing cohort infrastructure, which has historically achieved high retention rates.

Intervention: SCIP consists of three integrated components: 1. Community Activities and Educational Talks: Monthly group activities designed to promote social participation, health education, and community engagement. Activities include cultural events, group discussions, and interactive workshops; 2. Peer-Support Groups: Monthly small-group sessions facilitated by trained personnel, focusing on emotional support, shared experiences, and collective problem-solving. These sessions aim to strengthen interpersonal connections and reduce feelings of loneliness , and 3. Home-Based Coaching: Twice-monthly individualized coaching sessions delivered in participants' homes. The coaching incorporates principles of Social Cognitive Theory and Cognitive Behavioral Therapy, emphasizing goal-setting, self-efficacy, coping strategies, and behavior change to support healthier lifestyles and social engagement.

The comparison communities will continue with their usual activities and will not receive SCIP during the study period.

Outcomes: The primary outcomes are changes in social isolation and loneliness from baseline to 12 months, measured using the Lubben Social Network Scale-6 (LSNS-6) and the De Jong Gierveld Loneliness Scale. Secondary outcomes include cardiovascular health assessed through the American Heart Association's Life's Essential 8 metrics, sleep quality (Pittsburgh Sleep Quality Index), cognitive performance (Montreal Cognitive Assessment), depressive symptoms (DASS-21), and quality of life (SF-36). Exploratory outcomes include incident stroke, cardiovascular events, vascular mortality, and all-cause mortality, monitored through ongoing community surveillance.

Data Collection and Management: Data will be collected through face-to-face interviews, validated questionnaires, and standardized clinical measurements. All data will be stored in a secure, encrypted database with restricted access. Quality control procedures include periodic audits and verification of data completeness and accuracy.

Statistical Analysis: Analyses will follow an intention-to-treat approach. Mixed-effects models will be used for continuous outcomes, logistic regression or generalized estimating equations for categorical outcomes, and Cox proportional hazards models for time-to-event outcomes. Multiple imputation will be used to address missing data. Sensitivity analyses will assess the robustness of findings.

Ethics and Dissemination: The study has been approved by the Independent Review Board of Hospital-Clínica Kennedy (FWA: 00030727). Protocol amendments will be submitted to the IRB and updated in the trial registry. Results will be disseminated to the community, local health authorities, scientific conferences, and peer-reviewed journals.

This study will provide valuable evidence on the feasibility, acceptability, and effectiveness of a culturally adapted, community-based intervention to reduce loneliness and social isolation and promote cardiovascular and brain health among older adults in a resource-limited rural setting. Findings may inform scalable public health strategies for healthy aging in similar contexts.