NCT06800027: SALSA

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

Completed NA Last updated 29 January 2025

What this trial tests

NA trial testing SALSA group intervention: Going to lunch at the restaurant in a group and attending healthy eating workshops. in Depression in 98 participants. Completed in 30 July 2024.

Timeline

15 January 2024

Primary endpoint
30 July 2024

30 July 2024

Quick facts

Lead sponsor	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	98
Start date	15 January 2024
Primary completion	30 July 2024
Estimated completion	30 July 2024
Sites	1 location across Spain

Drugs / interventions tested

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

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Social Support (Formal and Informal) — all drugs for Social Support (Formal and Informal) →
• Quality of Life (QOL) — all drugs for Quality of Life (QOL) →

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →

Who can join

Eligibility, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.