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

NCT07319663 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER
  • Universidad de Especialidades Espiritu Santo

    lead OTHER

Principal Investigators

  • Oscar H Del Brutto, MD · Proyecto Atahualpa

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • Ecuador

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319663 on ClinicalTrials.gov