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

NCT06800027 | Completed

• 1 other identifier: 23/285-P
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Loneliness; Depression; Anxiety; Social support; Quality of life

Outcome Measures

Primary Outcomes (4)

• Depression

  Clinical remission of depression or response to the intervention at the end of the intervention. Clinical remission is defined as a Beck Depression Inventory (BDI-II) score \<14, and response to the intervention is defined as a decrease in the initial score

  4 months

• Anxiety

  Clinical remission of anxiety or response to the intervention at the end of the intervention. Clinical remission is defined as a score \<10 on the GAD-7 scale (Generalized Anxiety Disorder), and response to the intervention is defined as a reduction in the baseline score

  4 months

• Social support

  Improvement in social support after the intervention. A response to the intervention is defined by a decrease in the Duke-UNC-11 Social Support Questionnaire score, with a score \<32 indicating good social support

  4 months

• Health-Related Quality of Life

  Improvement in Health-Related Quality of Life (HRQoL) after the intervention: an improvement in HRQoL is considered if there is a decrease in the EuroQol (EQ-5D) questionnaire score compared to the baseline.

  4 months

Secondary Outcomes (7)

• Clinical variables

  4 months

• Adherence to the Mediterranean diet

  4 months

• Visits made to the primary care centre

  8 months

• Visits made to the emergency department

  8 months

• Referrals to the hospital

  8 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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. 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.

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

Control grup

NO INTERVENTION

The control group will receive standard care at their Primary Care Centre.

Interventions

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

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Autonomous individuals experiencing issues related to living alone or feeling lonely (Z60) (e.g., elderly, migrants, those with functional diversity, etc.), at risk of malnutrition or emotional disorders, with a score of ≥14 and \<28 on the Beck Depression Inventory (BDI-II), a score of ≥10 on the Generalized Anxiety Disorder (GAD-7) scale, or a score of ≥32 on the Duke-UNC-11 Social Support Scale; ability to undergo follow-up for 8 months, ability to read and write in Spanish or Catalan, and the ability to attend the restaurant twice a week.

You may not qualify if:

• Diagnosis of dementia or moderate cognitive impairment, diagnosis of major depression (BDI-II score ≥28), alcohol or drug abuse, physical or mental impairment preventing attendance at the restaurant two or three times a week, failure to sign the informed consent form, participation in other food support programmes by social services or not being responsible for their own nutrition.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Fundació Alícia: collaborator

Study Sites (1)

Unitat de Suport a la Recerca de la Catalunya Central, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Manresa, Spain

Manresa, Barcelona, 08242, Spain

Location

Related Publications (8)

• Rockwood K. What would make a definition of frailty successful? Age Ageing. 2005 Sep;34(5):432-4. doi: 10.1093/ageing/afi146.

  PMID: 16107450 BACKGROUND

• Urzua M A. [Health related quality of life: Conceptual elements]. Rev Med Chil. 2010 Mar;138(3):358-65. Epub 2010 May 19. Spanish.

  PMID: 20556342 BACKGROUND

• 8. Institut d'Estadística de Catalunya. Població a 1 de gener 2023. Available online: https://www.idescat.cat/indicadors/?id=aec&n=15231 (accessed on 24 october 2023).Proyecciones de Población 2022-2072. Available online: https://www.ine.es/prensa/pp_2022_2072.pdf (accessed on 24 october 2023).

  BACKGROUND

• Gene-Badia J, Comice P, Belchin A, Erdozain MA, Caliz L, Torres S, Rodriguez R. [Profiles of loneliness and social isolation in urban population]. Aten Primaria. 2020 Apr;52(4):224-232. doi: 10.1016/j.aprim.2018.09.012. Epub 2019 Feb 12. Spanish.

  PMID: 30770152 BACKGROUND

• Lubetkin EI, Jia H, Franks P, Gold MR. Relationship among sociodemographic factors, clinical conditions, and health-related quality of life: examining the EQ-5D in the U.S. general population. Qual Life Res. 2005 Dec;14(10):2187-96. doi: 10.1007/s11136-005-8028-5.

  PMID: 16328899 BACKGROUND

• Dent E, Wright ORL, Woo J, Hoogendijk EO. Malnutrition in older adults. Lancet. 2023 Mar 18;401(10380):951-966. doi: 10.1016/S0140-6736(22)02612-5. Epub 2023 Jan 27.

  PMID: 36716756 BACKGROUND

• Cacioppo JT, Cacioppo S. Older adults reporting social isolation or loneliness show poorer cognitive function 4 years later. Evid Based Nurs. 2014 Apr;17(2):59-60. doi: 10.1136/eb-2013-101379. Epub 2013 Jun 8. No abstract available.

  PMID: 23749730 BACKGROUND

• Nyqvist F, Nygard M, Scharf T. Loneliness amongst older people in Europe: a comparative study of welfare regimes. Eur J Ageing. 2018 Sep 6;16(2):133-143. doi: 10.1007/s10433-018-0487-y. eCollection 2019 Jun.

  PMID: 31139028 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: January 15, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)