SALSA (Health, Food and Sociability): Community Networks for Healthy Eating, Autonomy, and Social Interaction

NCT06800027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-01-29

No results posted yet for this study

Summary

Antecedents: Unwanted loneliness is associated with an increased risk of anxiety, depression, social isolation, and malnutrition. The SALSA project aims to establish mechanisms and create an ecosystem that enables healthcare and social services to prescribe meals at pre-trained local restaurants. The goal is to encourage socialisation and simultaneously ensure a diet tailored to the user's needs, without stigmatisation, new infrastructure, or additional staffing.

Hypotheses: Individuals experiencing unwanted loneliness with a risk of anxiety, depression, and malnutrition will improve their emotional and nutritional status, social support, and quality of life if they dine at a restaurant in a group, accompanied by a facilitator, twice a week.

Objectives: To assess whether dining at a restaurant twice a week in a group, accompanied by a facilitator, and participating in healthy eating workshops improves the emotional and nutritional status, social support, and quality of life of individuals experiencing unwanted loneliness.

Methodology:

Design: Randomised clinical trial with two groups. Inclusion Criteria: Autonomous individuals experiencing challenges related to living alone (Z60), at risk of malnutrition or emotional disorders, with a score of ≥14 and \<28 on the Beck Depression Inventory (BDI-II), ≥10 on the Generalised Anxiety Disorder scale (GAD-7), or ≥32 on the DUKE-UNC-11 Social Support Scale. Participants must be able to attend follow-ups over eight months, read and write in Spanish or Catalan, and dine at a restaurant twice a week.

Measurements: Sociodemographic variables, assessments of depression, anxiety, social support, quality of life, and clinical variables such as weight, height, body mass index, blood pressure, haemogram and formula, glycated haemoglobin, total cholesterol, HDL, LDL, triglycerides, albumin, iron, ferritin, vitamin B12, and folate. Adherence to the Mediterranean diet, intervention satisfaction and compliance, and the number of primary care visits will also be measured during pre-intervention (4 months), intervention (4 months), and post-intervention (4 months) periods. Confounding or effect-modifying variables will also be recorded.

Statistical Analysis: Initially, the sociodemographic characteristics of both groups will be described. Percentages will be used for qualitative variables, and means with standard deviations or medians with ranges and interquartile ranges (25-75) for quantitative variables. Baseline scores on selected scales will be compared post-randomisation to ensure no significant differences. Post-intervention, mean scores across scales and variables will be compared for each group independently and for different post-intervention time periods using paired Student's t-tests (for normally distributed data) or Mann-Whitney U tests (for non-normal distributions). Secondary analyses will include multiple regression, incorporating sociodemographic and confounding variables, to assess clinical remission of depression (Yes: Beck scale \<12), anxiety (Yes: GAD-7 \<10), and social support (Yes: DUKE-UNC-11 \>32).

Expected Results:

The intervention group is expected to show improvements in emotional and nutritional status, social support, and quality of life.

Applicability and Relevance:

The proposed solution leverages existing infrastructure-neighbourhood restaurants, historically spaces for gathering and socialisation, which are currently under threat. These venues could become vital players in the socio-health sector, acting as nutrition caretakers for a specific group of individuals. This approach avoids the need for new canteens or facilities, instead relying on skilled professionals who already exist within the community, while also supporting local economic activity.

By enabling individuals experiencing unwanted loneliness to access group dining in pre-trained restaurants, the intervention aims to improve emotional well-being through social interaction, foster better nutrition, and enhance quality of life. These benefits could result in reduced healthcare visits and less need for medication.

Conditions

  • Depression
  • Anxiety
  • Social Support (formal and Informal)
  • Quality of Life (QOL)
  • Loneliness
  • Malnutrition

Interventions

OTHER

SALSA group intervention: Going to lunch at the restaurant in a group and attending healthy eating workshops.

The intervention group will dine at a selected and trained restaurant twice a week for 4 months (from March to June 2024). A facilitator will accompany the participants to the restaurant and supervise them. Once a month, a healthy habits and meal supplementation workshop will be held at the senior citizens' centre. Participants will not be required to pay for the meals at the restaurant or for participation in the workshops. The control group will receive standard care at their Primary Care Centre. In order for the restaurant to provide appropriate services tailored to the users' needs, training will be conducted by professionals from the Alicia Foundation on how to manage the nutrition of elderly individuals and other participants in the study according to their dietary needs.

Sponsors & Collaborators

  • Fundació Alícia

    collaborator UNKNOWN
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-07-30
Completion
2024-07-30

Countries

  • Spain

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 NCT06800027 on ClinicalTrials.gov