Community-based social connection intervention programme to improve cardiovascular and brain health in older adults in rural Ecuador: study protocol for a quasi-experimental trial.

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Learn more: PMC Disclaimer | PMC Copyright Notice BMJ Open . 2026 Jun 1;16(6):e118544. doi: 10.1136/bmjopen-2026-118544 Community-based social connection intervention programme to improve cardiovascular and brain health in older adults in rural Ecuador: study protocol for a quasi-experimental trial Victor J Del Brutto 1 , Giselle Leal 2 , Robertino M Mera 3 , Denisse A Rumbea 4 , Maria Jose Abad 5 , Oscar H Del Brutto 4, ✉ Author information Article notes Copyright and License information 1 University of Miami, Miller School of Medicine, Miami, Florida, USA 2 Insight Neurocognitive and Behavioral Center, Miami, Florida, USA 3 Statistics/Epidemiology, Freenome Holdings Inc, South San Francisco, California, USA 4 Research Center, Universidad de Especialidades Espiritu Santo, Samborondon, Ecuador 5 School of Clinical Psychology, Universidad de Especialidades Espiritu Santo, Samborondon, Ecuador Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages) and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. None declared. ✉ Oscar H Del Brutto; odelbrutto@uees.edu.ec Received 2026 Feb 18; Accepted 2026 May 19; Collection date 2026. Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13239703  PMID: 42225361 Abstract Introduction Loneliness and social isolation are increasingly recognised as determinants of cardiovascular and brain health, particularly among older adults. Evidence from high-income settings links social disconnection to higher risk of coronary heart disease, stroke, cognitive decline and mortality, yet few interventions have been adapted for rural, resource-limited environments. In rural coastal Ecuador, demographic stability, low migration and strong community engagement provide a unique context to evaluate a culturally grounded intervention. This study aims to determine whether a multi-component social connection intervention programme (SCIP), informed by the Social Cognitive Theory, can reduce loneliness and social isolation and improve cardiovascular, cognitive and psychosocial outcomes among older adults living in three rural villages participating in a population-based cohort. Methods and analysis This quasi-experimental matched-control study will be conducted in Atahualpa (intervention site) and the neighbouring villages of El Tambo and Prosperidad (control sites). Eligible participants are adults aged ≥60 years without disability, dementia or major psychiatric illness. Intervention participants will be matched to controls using variable-ratio propensity score methods. The 12-month SCIP includes monthly community educational activities, peer-support group sessions and individualised coaching (two times per month) focused on skill-building, goal-setting and cognitive-behavioural strategies. Participants in the control villages will receive usual community and primary care services without exposure to SCIP activities. Baseline and 12-month assessments will measure social isolation, loneliness, cardiovascular health, sleep quality, cognitive performance, depressive symptoms and quality of life. Incident stroke, cardiovascular disease and mortality will be monitored quarterly. Analyses will use mixed-effects models for continuous and categorical outcomes and Cox proportional hazards models for incident events, adjusting for relevant confounders. Ethics and dissemination The protocol was approved by the Ethics Committee of Hospital-Clinica Kennedy, Guayaquil. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications, conference presentations and community reports. Results may inform scalable strategies to enhance psychosocial well-being and reduce cardiovascular and cognitive risk in underserved rural populations. Trial registration number NCT07319663 . Keywords: PUBLIC HEALTH, GERIATRIC MEDICINE, SOCIAL MEDICINE STRENGTHS AND LIMITATIONS OF THIS STUDY. Culturally adapted, theory-informed intervention designed specifically for older adults in rural, low-resource settings. Quasi-experimental matched-control design using variable-ratio propensity score matching to improve baseline comparability. Embedded in a stable population-based cohort, enabling high retention and consistent longitudinal measurement. Comprehensive outcome assessment spanning social, cardiovascular, cognitive, sleep and psychosocial domains. Non-randomised design may allow residual confounding and findings may not generalise beyond similar rural communities. Introduction Non-communicable disorders such as cardiovascular disease (CVD), stroke and cognitive impairment are emerging as major public health challenges in middle-and-low income countries (MLIC) as life expectancy increases. 1 , 3 Promoting heart and brain health is therefore a global priority. The American Heart Association (AHA) Life’s Essential 8 framework highlights the importance of healthy behaviours and metabolic factors in maintaining cardiovascular health (CVH), 4 while growing evidence demonstrates that psychosocial health also exerts an independent influence on CVD and brain health outcomes. 5 6 Psychosocial health encompasses mental, emotional and social well-being. In this context, addressing and improving social functioning represents a potentially cost-effective strategy to improve cardiovascular and brain health in developing regions. Social functioning can be conceptualised through the related but distinct concepts of social isolation and loneliness. Social isolation refers to the objective absence of meaningful interpersonal interactions, whereas loneliness reflects the subjective negative perception of inadequate or unfulfilling social connections. 7 Both constructs influence health through distinct pathways and are independently associated with poorer health outcomes and reduced quality of life (QoL). Meta-analyses of large cohort studies demonstrate that individuals experiencing social isolation and loneliness have approximately 29% higher risk of incident coronary heart disease and 32% higher risk of stroke. 8 Social isolation has also been associated with elevated all-cause and cardiovascular mortality, independent of traditional risk factors. 9 Regarding brain health, loneliness—but not necessarily social isolation—has been associated with a 26% increased risk of dementia, 10 and greater social integration mitigates cognitive decline. 11 These findings underscore the need to integrate social health within comprehensive prevention strategies targeting cardiovascular and brain health outcomes. Most interventions to address loneliness and social isolation have been evaluated in high-income countries, limiting their generalisability and contextual relevance globally. 12 In the USA and the UK, loneliness affects 20%–30% of older adults and social isolation approximately 25%. 13 National initiatives in high-income countries illustrate growing recognition of this issue. 14 Although these organisations have proposed strategies to decrease loneliness and social isolation, no consensus exists on the most effective or scalable interventions, particularly in rural or low-income settings. Rural populations in MLIC may be particularly vulnerable to loneliness and social isolation due to factors such as migration, discrimination, limited transportation, inadequate healthcare access and poor digital connectivity. Yet the experience of social disconnection in these settings may differ, shaped by close-knit communities and distinct cultural norms. 15 Older adults in these areas face heightened risk of social disconnection because of retirement, reduced income, family dispersal, bereavement, impaired mobility and cognitive decline. 16 17 To address the burden of social disconnection and their impact on cardiovascular and brain health in a low-income rural setting, we propose leveraging the established infrastructure of a population-based cohort study in rural coastal Ecuador to implement a controlled longitudinal interventional study applying a multi-strategy social connection intervention programme (SCIP) adapted from evidence-based approaches in high-income countries. 16 These approaches typically incorporate group-based activities, skill-building strategies and structured coaching, elements that were adapted to the cultural and logistical context of rural Ecuador. The primary objective of this study is to determine if a multi-strategy social connection intervention can significantly improve isolation and loneliness. Secondary outcomes include the potential impact of SCIP on improving CVH, reducing stroke and CVD risk, mitigating cognitive decline and enhancing QoL. Exploratory objectives include changes in the rate of incident stroke, CVD, vascular mortality and all-cause mortality. The study is expected to improve social connection, reduce loneliness and social isolation and potentially influence cardiovascular risk factors. At the population level, the findings may inform scalable community-based strategies for rural MLIC settings. Methods and analysis This protocol was developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 for transparency, reproducibility and ethical conduct. 18 Given the quasi-experimental community-based design, items related to randomisation and allocation concealment were adapted accordingly ( online supplemental file 1 ). The trial registration number is NCT07319663 , protocol V.1.2, May 2026 ( ClinicalTrials.gov ). Study design The study is scheduled to begin on 1 June 2026, and conclude 12 months later on 1 June 2027, This quasi-experimental study consists of an untreated control group and an intervention group with a pre-test and a post-test. This study design is interpretable given that the intervention and the control groups are made similar to each other at baseline by propensity score matching. All available baseline information both at the locality (village) and at the individual level is used to build the propensity score. Study settings The study will be conducted in three neighbouring rural villages of coastal Ecuador: Atahualpa, El Tambo and Prosperidad. These communities have been previously characterised as part of an established population-based cohort aimed at reducing the burden of non-communicable neurological and CVDs in the region. 19 Initiated in 2013 in Atahualpa (the Atahualpa Project), the study expanded in 2019 to include the villages of El Tambo and Prosperidad, collectively known as the Three Villages Study. As part of this ongoing cohort, residents aged ≥40 years were identified through door-to-door surveys and, after providing written informed consent, have been followed annually using standardised clinical questionnaires. Based on more than a decade of longitudinal follow-up in this population, we do not anticipate substantial attrition; previous cohort waves have documented only ~6% cumulative dropout over 12 years, reflecting the demographic stability and low migration rates of these rural communities. 20 In addition, our team has a long-standing presence in the area and has conducted multiple community talks and health-promotion activities with consistently high attendance, fostering trust, visibility and strong community engagement that support sustained participation in research initiatives. 21 Characteristics of the study population The populations of the included villages are homogeneous in terms of race and ethnicity (predominantly Amerindian ancestry), socioeconomic status and lifestyle. Most men work as artisan carpenters, tailors or farmers, while most women are homemakers. Dietary habits are characterised by high consumption of oily fish, carbohydrates and vegetables and limited intake of red meat, dairy products and highly processed foods. Educational attainment is low, with most residents having completed only primary school, and CVH profiles are comparable across the three villages. 19 22 Eligibility criteria The study has an intervention arm and a control arm. This stratification was informed by sample size, given that the participant count in the intervention village (Atahualpa) matched the aggregate number from the control populations (El Tambo and Prosperidad). Individual randomisation within the same village was avoided because participants share social networks and daily interactions. Randomising individuals in the same community to different study arms could have led to contamination, as participants exposed to the intervention might discuss intervention-related behaviours to those assigned to the control group. To minimise this risk and preserve internal validity, villages were used as the unit of allocation, resulting in a quasi-randomised cluster design. Participants will include community dwellers aged ≥60 years, who resided in the villages for >1 year with no plans to relocate. Individuals with severe disability, dementia, stroke or major psychiatric illness will not be included. Exclusion criteria (disability, dementia and major psychiatric illness) will be identified using existing cohort records and confirmed through standardised clinical evaluations routinely conducted in the Three Villages Study. Addressing potential bias The main threat to validity with non-equivalent groups design is selection bias. This is addressed through the matching procedure which includes both town level and individual level variables. The variable ratio matching enhances the probability of both intervention and control groups being similar at baseline, therefore reducing selection bias. The interaction of selection and history biases corresponds to the local history bias, which is addressed by using causal statistical models incorporating the potential confounder and testing its influence (sensitivity analyses). Study organisation The principal investigators and the study coordinator will be responsible for overseeing all the activities of the study, including translation and back translation of field instruments to a colloquial language understandable to the population, training and monitoring field personnel to assure uniformity in data collection, data entry and review of complementary examinations. Coordination of the Three Villages study is located at the community centre of the Atahualpa Project (Atahualpa), which will serve for clinical interviews, community talks and secure storage of informed consent forms, filled questionnaires and complementary tests, according to the Health Insurance Portability and Accountability Act (HIPAA). Only the principal investigators, the study coordinator and the designated statistician will have access to the final anonymised dataset. Study procedures Following a quasi-experimental design, active participants from this ongoing cohort will be invited to take part in the SCIP study. A 1-year multi-strategy SCIP consisting of community education sessions, group skill-building activities and individualised coaching will be implemented in Atahualpa (intervention group; figure 1 ); El Tambo and Prosperidad will serve as comparison sites (control group). Data will be collected at baseline and at the end of the study (1 year) using standardised procedures across all three villages. Additionally, participants will be surveyed quarterly during the study year to assess for incident strokes, CVDs, permanence into the villages and vital status. Figure 1. One-year multi-strategy social connection intervention programme consisting of community education sessions, group skill-building activities and individualised coaching. Left side of the panel shows inclusion criteria and baseline data questionnaires, and right side shows primary and health outcomes. Open in a new tab The propensity score which computes the propensity to live in Atahualpa versus the probability of living in El Tambo or Prosperidad will be used to match, on a variable-ratio basis, the intervention cases to control cases with the objective of matching cases and controls that on the average at a population scale are similar. A nearest neighbour matching procedure will be used and an area of common support computed and recursively used to optimise the overall similarity of the most important confounders. Retention strategies include reminder visits, flexible scheduling and home-based coaching, which have historically resulted in high participation rates in this cohort. Outcome measures Participants in the intervention and control groups will be interviewed face-to-face by trained personnel using standardised procedures to ensure consistency across sites. They will collect demographics, baseline clinical data and complete study-related questionnaires. Standardised, validated questionnaires will assess social isolation, loneliness, CVH, sleep quality, cognitive performance, QoL and depression, along with health outcomes including incident stroke, CVD, cognitive decline as well as vascular mortality and all-cause mortality. Social isolation will be assessed using the 6-item Lubben Social Network Scale (LSNS-6; range 0–30), with lower scores indicating greater isolation and scores ≤12 denoting high-risk isolation. 23 Loneliness will be measured using the 6-item De Jong Gierveld Loneliness Scale (range 0–6), with separate subscales for emotional and social loneliness (0–3 each), where higher scores indicate greater perceived loneliness. 24 Changes in scores from baseline to the end of the study (1 year) will be used to determine the primary outcome. CVH will be assessed through the AHA Life’s Essential 8 construct. 4 This framework evaluates diet (according to the Dietary Approaches to Stop Hypertension (DASH) score), physical activity, nicotine exposure, sleep health (nighttime sleep duration), body mass index (BMI), blood lipids (high-density lipoproteins (HDL) and total cholesterol), blood glucose (fasting glucose+haemoglobin A1c) and blood pressure (systolic and diastolic). In accordance with this construct, participants with poor individual health metrics included those who: (1) had DASH scores below the 25th percentile; (2) reported ≤29 min of moderate to vigorous physical activity per week; (3) were current smokers or had quit <1 year ago or were currently using inhaled nicotine delivery systems; (4) had a nighttime sleep duration <6 or >10 hours; (5) had a BMI ≥30 kg/m 2 ; (6) had non-HDL cholesterol levels ≥160 mg/dL; (7) had diabetes according to the American Diabetes Association criteria and (8) had ≥140 mmHg systolic or ≥90 mmHg diastolic pressure. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) 25 to complement the information on non-breathing sleep-related disorders provided by the Life’s Essential 8 framework. 4 The PSQI is a validated instrument comprising 18 items across seven components: duration, disturbances, latency, daytime dysfunction, efficiency, perceived quality and sleep medication use. This scale has previously been translated to Spanish and validated by our group. 26 Using the PSQI, a score of ≤5 indicated good sleep quality. The Spanish version of the Montreal Cognitive Assessment (MoCA; www.mocatest.org , V.07, November 2004) will be used to assess cognitive performance. The MoCA evaluates several cognitive domains, including: (1) visuospatial executive skills for up to 5 points; (2) animal naming ability for up to 3 points; (3) language proficiency for up to 3 points; (4) short-term memory capacity for up to 5 points; (5) abstraction skills for up to 2 points; (6) attention and calculation abilities for up to 6 points; and (7) orientation awareness for up to 6 points. The maximum score is 30 points, with an additional point given to persons with ≤12 years of education. 27 The cut-off of ≤25 points used to define cognitive impairment in highly educated populations will not be used in this study because of its poor reliability in populations with low literacy. 28 29 Instead, we will use the continuous MoCA score for analyses. Baseline and end-of-study follow-up MoCA evaluations will be performed to assess cognitive trajectories over the study period. Symptoms of depression will be assessed using the depression axis of the Depression Anxiety Stress Scale–21 (DASS-21), 30 a validated self-reported instrument adapted to Spanish. 31 The DASS-21 quantifies dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia, each rated on a 4-point Likert scale (0–3). Total scores for each domain are multiplied by 2 and categorised as normal, mild, moderate, severe or extremely severe, according to established cut-offs. 30 We will use the pre-established cut-off of ≥5 points to define depression. QoL will be evaluated using the 36-Item Short Form Health Survey (SF-36), adapted and validated in Spanish. 32 The SF-36 assesses eight domains of physical and mental health, each scored from 0 to 100, with higher scores indicating better perceived health-related QoL. Health outcomes These will include incident stroke, CVD, vascular mortality and all-cause mortality, screened quarterly. Stroke will be defined as neurological deficits lasting >24 hours without alternative cause, identified using a questionnaire validated in our population. Positive cases will be evaluated by a certified neurologist and suspected cases will undergo brain MRI and a complete stroke workup as previously described. 33 CVD screening will follow the WHO-recommended Rose Angina Questionnaire 34 and positive cases will be evaluated by a certified cardiologist with further workup as indicated. Vital status will also be assessed quarterly, complemented by verbal autopsy and review of medical records from the single local health centre, with causes of death classified as vascular using standardised instruments. Incident outcomes will be analysed individually and as a composite of CVD, cognitive decline, stroke and all-cause mortality. Sample size calculation Older adults who receive SCIP intervention are expected to significantly improve social integration as measured by a 15% increase in the social isolation score and a 20% increase in the loneliness score in the intervention group compared with the control group after adjusting for baseline covariates. Data from the same population points to an all-cause attrition rate of~6% over 12 years. A worst case scenario of 10% attrition is considered for the power and sample size calculation. The objective is to have sufficient statistical power (>80%) to detect a significant difference (p=0.05) in both the loneliness score and social integration. A rounded sample size of 250 cases and 250 controls, with an alpha of 0.05 on a two-tailed test of the difference between intervention and controls after adjusting for baseline values will have greater than 92% power to detect the difference predicted on each of the outcomes selected. The smallest effect size requires 173 subjects per group with 80% power. We nonetheless considered a 10% attrition rate and the availability of statistical power to evaluate strata within outcomes without the need to adjust for multiple comparisons. Patient and public involvement Participants and community members were not involved in the design of the study, selection of outcomes or development of study procedures. However, the intervention was culturally adapted based on long-standing engagement with this rural cohort and discussions with local community leaders regarding feasibility and acceptability. Participants were not involved in recruitment or conduct of the study. The study findings will be disseminated to participants and community authorities through local meetings and summary reports. Statistical analysis Data analysis will be carried out using STATA V.19 (StataCorp LLC,College Station, Texas, USA). Baseline characteristics of the intervention and control populations will be summarised using means (SD) or medians (IQR) for continuous variables and frequencies (%) for categorical variables. Changes in social isolation (LSNS-6) and loneliness (De Jong Gierveld Loneliness Scale) from baseline to 12-month follow-up will be analysed. Both continuous scores and the proportion classified as ‘high risk’ (expected 25% at baseline) will be evaluated. Analyses will be adjusted for baseline demographics, education, vascular risk factors, depression and cognitive performance. Linear mixed-effects models will be used for continuous outcomes, and logistic regression or generalised estimating equations for categorical outcomes. Effects of the intervention on CVH (Life’s Essential 8, poor vs non-poor), cognitive performance (MoCA, continuous) and QoL (SF-36, continuous) will be assessed from baseline to follow-up. Models will be adjusted for demographics, education, depression and vascular risk factors, using linear or logistic mixed-effects models as appropriate. Associations between the intervention and incident vascular events (composite of stroke, CVD or vascular death) during follow-up will be analysed using Cox proportional hazards models, adjusted for demographics and vascular risk factors. Time-to-event analyses will consider censoring at study end, death or loss to follow-up. Analysis will be conducted on an intention-to-treat basis. Analyses will then be performed among compliant participants, defined as those attending more than 50% and more than 80% of sessions, respectively. All analyses will be two-sided with a significance level of 0.05. Missing data will be addressed using appropriate multiple imputation methods. Intervention The SCIP was developed within the Social Cognitive Theory (SCT) framework, which emphasises the dynamic interplay between personal factors, behaviour and environmental influences. 35 This framework is particularly suited to the present study, as social isolation and loneliness in rural older adults often arise from both individual and contextual barriers to social engagement. The SCIP focuses on reducing loneliness and social isolation among rural community-dwelling older adults while promoting physical, cognitive and social well-being through guided opportunities for learning (behavioural capability), social interaction (observational learning and reciprocal determinism) and skill mastery (self-efficacy), supported by positive reinforcement and environmental facilitators to encourage sustained behavioural change. All intervention components will be delivered by trained study coaches with backgrounds in psychology and/or prior experience working with this rural population. Adverse events related to physical or emotional activities will be documented and participants will be referred to the local health centre when needed. Additionally, periodic quality checks will be conducted by the central study team. Previous studies have demonstrated that interventions addressing loneliness and social isolation are most effective when they include active participation , educational components and group-based formats. 36 37 According to the National Academies of Sciences, Engineering, and Medicine (2020), successful interventions often rely on socially engaging, skill-building and educational strategies that empower older adults to take an active role in their social and health behaviours, rather than relying on passive information delivery. 38 Consistent with these findings, studies across the past two decades have also suggested that interventions fostering skill development, peer interaction and community engagement yield greater and more sustained improvements in loneliness and perceived social support than purely informational or passive approaches. 39 , 44 Guided by this evidence and the principles of SCT, the present intervention integrates three complementary components: (1) monthly community activities and educational talks , (2) monthly peer-support group sessions and (3) two times per month individualised home-based coaching visits. The latter two interventions will be delivered under the supervision of a designated coach, a study team member with expertise in psychology and familiarity with the population’s cultural context. Monthly community activities and talks These sessions will be conducted in person at the local community centre. Each session will last approximately 60 min and will be held at the Atahualpa Community Center, following a standardised monthly curriculum. These events are designed to create a shared learning environment and serve as a facilitation mechanism, increasing opportunities for social interaction and observational learning. The sessions will consist of didactic presentations and interactive activities focused on health and wellness topics relevant to ageing populations, such as physical activity, nutrition, sleep, CVH, mental health and social engagement. Talks and activities will promote outcome expectations by highlighting tangible benefits of adopting health-promoting and socially engaging behaviours. Monthly topics will align with community interests, beginning with an introduction to the programme (month 1) and progressing through health-related and psychosocial themes, culminating with a closure and reflection event (month 12). Monthly peer-support group sessions Participants will be assigned to small peer-support groups of approximately 15 members, led by a study coach. Peer-support sessions will also last approximately 60 min and will take place in designated community spaces to ensure privacy and consistency. Group sessions follow structural session guides to ensure participants are exposed to the same cover context each month. Each group will meet once per month to reinforce the monthly topics, concepts and skills introduced during the community activities/talks. The coach will gather information about the interests, personal concerns and preferred discussion topics of each participant to ensure that group content is personally meaningful and culturally relevant. These sessions will allow the participants to contribute actively to discussions, enhancing self-efficacy through shared experiences and mutual reinforcement. Because members resided in close proximity, the expectation is that these relationships often extended beyond formal meetings, facilitating sustained social interaction and community integration. The design of the group intervention draws on evidence that group-based, activity-oriented and educational programmes tailored to specific subgroups of older adults are effective in reducing loneliness and social isolation. 45 46 Individual coaching sessions Each participant will receive a 1-hour face-to-face individualised coaching two times per month. These home-based visits follow structured session guides to ensure that all participants receive the same core content each month, and will focus on personalising the strategies introduced in the group and community settings, ensuring transfer of learning to real-life contexts. The individualised approach will facilitate targeted self-efficacy building through skill practice and continuous feedback. Coaches will collaborate with participants to establish and review individualised specific, measurable, assignable, realistic, time-related (SMART) goals tailored to their health and social needs, identify barriers and implement strategies to strengthen self-efficacy, and develop behavioural capabilities in social and communication domains to promote connectedness and independence. 47 They will use verbal persuasion to encourage adaptive behaviours related to physical activity, diet, medication adherence, safety and purposeful engagement after retirement. In addition, elements of Cognitive Behavioural Therapy (CBT) will be incorporated to help participants challenge maladaptive beliefs (eg, ‘I am a burden to others’) and adopt more adaptive cognitive and behavioural patterns, consistent with meta-analytic findings, indicating that CBT-based interventions are among the most effective approaches for reducing loneliness. 42 Home-based sessions will also provide opportunities for environmental facilitation, as coaches will assist participants to identify and modify aspects of their environment that could either support or hinder engagement in social and health-promoting behaviours. By addressing both individual and environmental factors within a cohesive community framework, the overarching goal of the SCIP is to e nhance social connectedness, increase opportunities for meaningful social interaction, and reduce social isolation and loneliness , while simultaneously promoting health-related self-efficacy and improving overall physical, cognitive and social functioning through semi-structured, theory-driven interactions. Ethics and dissemination The Ethics Committee of Hospital-Clínica Kennedy in Guayaquil, Ecuador (Federal Wide Assurance: 00030727), approved the study protocol and the informed consent procedures. All participants will provide written informed consent before enrolment ( online supplemental file 2 ). The study will adhere to the ethical principles outlined in the Declaration of Helsinki. On completion, the findings will be disseminated through peer-reviewed publications, conference presentations and community-focused reports. The results may inform scalable strategies to improve psychosocial well-being and reduce cardiovascular and cognitive risk in underserved rural populations. If the intervention demonstrates meaningful benefits, the same procedures will be offered to the communities assigned to the control group. Discussion The present study introduces and evaluates a community-based, theory-driven intervention aimed at reducing loneliness and social isolation while promoting cardiovascular and brain health among older adults in rural coastal Ecuador. Findings from this work are expected to contribute to the growing body of evidence linking psychosocial well-being with cardiovascular and brain health outcomes, particularly in under-represented, resource-limited settings. Furthermore, the study seeks to identify a cost-effective and impactful intervention that can be scaled to similar populations across the region. The SCIP represents an innovative adaptation of evidence-based models originally developed in high-income countries, contextualised to a low-resource, culturally cohesive rural environment. With SCT as its theoretical framework, the SCIP integrates education, community and peer engagement, as well as individualised coaching to address key determinants of social connection. By leveraging the infrastructure of the existing Three Villages cohort, the study ensures methodological rigour and longitudinal follow-up while maintaining ecological validity. The design of the intervention acknowledges that in rural Latin American communities, social disconnection often results not solely from personal or psychological barriers, but from structural limitations such as transportation, migration and economic instability. Thus, by combining community-level activities, small-group interactions and individualised coaching, the SCIP addresses social determinants at multiple levels, thereby maximising its potential impact. Consistent with findings from prior meta-analyses, 40 42 43 the SCIP prioritises active participation and skill-building over passive information delivery. The use of peer support groups and goal-oriented coaching is expected to strengthen social self-efficacy, a key SCT construct mediating sustained engagement and behavioural change. Moreover, incorporating CBT-based strategies into the individualised coaching component will encourage participants to challenge maladaptive cognitions linked to loneliness, thereby enhancing emotional regulation and adaptive coping. These mechanisms are particularly relevant to older adults, among whom loss of roles, mobility and perceived purpose often contribute to psychosocial decline. Beyond its psychosocial benefits, the potential impact of SCIP on cardiovascular and cognitive outcomes underscores the intersection between mental and physical health. Therefore, interventions that foster and strengthen social interaction are expected to improve vascular and neural integrity through improved health maintenance behaviours. Altogether, this study offers valuable contributions to methodological development and public health practice. First, its quasi-experimental community-based design allows for real-world implementation while maintaining comparability between intervention and control groups. Second, the use of standardised instruments facilitates cross-study comparison and potential scalability to other low-income and middle-income settings. Third, assessing outcomes across multiple levels, from perceived well-being to biological risk markers and clinical health events, allows for a more comprehensive understanding of how social connection influences cardiovascular and brain health. In conclusion, this protocol outlines a scalable, community-based intervention designed to strengthen social connection and reduce loneliness and social isolation in rural settings, with the potential to inform future public-health strategies in similar MLIC contexts. Supplementary material online supplemental file 1 bmjopen-16-6-s001.pdf (156.9KB, pdf) DOI: 10.1136/bmjopen-2026-118544 online supplemental file 2 bmjopen-16-6-s002.pdf (742.3KB, pdf) DOI: 10.1136/bmjopen-2026-118544 Footnotes Funding: The study is supported by an unrestricted academic grant from Universidad Espiritu Santo – Ecuador. The sponsor has no role in the design of the study, nor in the collection, analysis and interpretation of data. Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ( https://doi.org/10.1136/bmjopen-2026-118544 ). Provenance and peer review: Not commissioned; externally peer reviewed. Patient consent for publication: Consent obtained directly from patient(s) Ethics approval: This study involves human participants and was approved by Independent Review Board of Hospital‑Clínica Kennedy in Guayaquil, Ecuador (FWA: 00030727). Participants gave informed consent to participate in the study before taking part. Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. References 1. Mocumbi AO. Cardiovascular Health Care in Low- and Middle-Income Countries. Circulation. 2024;149:557–9. doi: 10.1161/CIRCULATIONAHA.123.065717. [ DOI ] [ PubMed ] [ Google Scholar ] 2. Alwan A, Maclean DR. 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