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

NCT ID: NCT07319663

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2027-05-01

Brief Summary

This study evaluates the effectiveness of a community-based social connection intervention program (SCIP) designed to reduce social isolation and loneliness and improve cardiovascular and brain health among older adults living in rural Ecuador. Loneliness and social isolation are recognized risk factors for poor cardiovascular outcomes, cognitive decline, depression, and reduced quality of life. However, evidence from low- and middle-income countries, particularly in rural Latin American settings, remains limited. This protocol describes a quasi-experimental, longitudinal study conducted in three rural villages that have been part of a long-standing population-based cohort.

The intervention will be implemented in one community and compared with two similar communities that will continue receiving usual community activities. SCIP consists of three components: (1) monthly community activities and educational talks designed to promote social participation; (2) monthly peer-support group sessions facilitated by trained personnel; and (3) individualized home-based coaching delivered twice per month, incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy. The program aims to strengthen social networks, enhance coping skills, and promote healthier behaviors.

Participants aged 60 years and older will be enrolled and followed for 12 months. Assessments will occur at baseline, 6 months, and 12 months. Primary outcomes include changes in social isolation (Lubben Social Network Scale-6) and loneliness (De Jong Gierveld Scale). Secondary outcomes include cardiovascular health (Life's Essential 8), 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, and mortality, monitored through ongoing community surveillance.

This study will generate evidence on the feasibility and impact of a culturally adapted, community-based intervention to promote social connection and healthy aging in a resource-limited rural setting. Findings may inform scalable public health strategies for older adults in similar contexts.

Detailed Description

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.

Conditions

Social Isolation in Older Adults; Loneliness; Stroke; Cognitive Decline

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

intervention community (SCIP)

Participants in this community receive the Social Connection Intervention Program (SCIP), which includes monthly community activities and educational talks, monthly peer-support group sessions, and twice-monthly individualized home-based coaching. The program is delivered over 12 months to reduce social isolation and loneliness and promote cardiovascular and brain health.

Group Type: EXPERIMENTAL

Social Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness.

Intervention Type: OTHER

The Social Connection Intervention Program (SCIP) is a 12-month, community-based program designed to reduce social isolation and loneliness among older adults in rural Ecuador. The intervention includes three components: (1) monthly community activities and educational talks to promote social participation and health awareness; (2) monthly peer-support group sessions facilitated by trained personnel to enhance emotional support and shared problem-solving; and (3) twice-monthly individualized home-based coaching sessions incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy to strengthen coping skills, goal-setting, and healthy behaviors. The program is delivered in the intervention community, while comparison c

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Social Connection Intervention Program (SCIP): Community activities, peer-support groups, and home-based coaching to reduce social isolation and loneliness.

The Social Connection Intervention Program (SCIP) is a 12-month, community-based program designed to reduce social isolation and loneliness among older adults in rural Ecuador. The intervention includes three components: (1) monthly community activities and educational talks to promote social participation and health awareness; (2) monthly peer-support group sessions facilitated by trained personnel to enhance emotional support and shared problem-solving; and (3) twice-monthly individualized home-based coaching sessions incorporating principles of Social Cognitive Theory and Cognitive Behavioral Therapy to strengthen coping skills, goal-setting, and healthy behaviors. The program is delivered in the intervention community, while comparison c

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age 60 years or more,
• residents of the study villages,
• no stroke,
• no significant disability,
• no dementia

Exclusion Criteria

• age younger than 60 years,
• previous stroke,
• disabled,
• demented

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Universidad de Especialidades Espiritu Santo

OTHER

Sponsor Role: lead

Responsible Party

Oscar H. Del Brutto

Director, the Atahualpa Project

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oscar H Del Brutto, MD

Role: STUDY_CHAIR

Proyecto Atahualpa

Locations

Universidad Espiritu Santo

Samborondón, Guayas, Ecuador

Countries

Ecuador

Central Contacts

Oscar H Del Brutto, MD

Role: CONTACT

oscardelbrutto@hotmail.com

593-997476984

Denisse A Rumbea, MHA

Role: CONTACT

denisse_rumbea@hotmail.com

593-994013452

References

Taylor HO, Cudjoe TKM, Bu F, Lim MH. The state of loneliness and social isolation research: current knowledge and future directions. BMC Public Health. 2023 Jun 1;23(1):1049. doi: 10.1186/s12889-023-15967-3.

Reference Type: RESULT

PMID: 37264355 (View on PubMed)

Other Identifiers

UniversidadEES

Identifier Type: -

Identifier Source: org_study_id