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临床试验/NCT06800027
NCT06800027已完成不适用

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
2
主要终点
Depression

研究概览

简要总结

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.

详细描述

ANTECEDENTS:

In Western countries, unwanted loneliness has a prevalence of 24 to 40% among individuals aged 65 and over, and it increases with age (1,2). Correlations have been reported between the feeling of loneliness and various health problems, including mental illnesses such as depression and anxiety, cardiovascular and cerebrovascular diseases, cancer, and low levels of emotional well-being (3,4). The issues caused by loneliness lead to a decline in quality of life, poor disease recovery, increased mortality, and high rates of socio-healthcare resource utilization among older adults (4).

Health-related quality of life (HRQoL) is defined as the perception of the physical, mental, and social effects of illness on well-being (5). HRQoL is considered an important health outcome among the population and an essential public health tool for assessing physical and social functioning, mental health, and well-being, as well as for evaluating population-based intervention programmes (6). Poor HRQoL perceptions have been associated with advanced age, lack of social support, high levels of depression, low self-esteem, lower social class, female gender, chronic medical conditions, high body mass index, and sedentary lifestyles (7).

The percentage of individuals aged 64 and over in Catalonia on 1 January 2023 was 19.34% (1,528,379 individuals) (8), and it is expected to increase further to 26% by 2037, according to data published by the National Institute of Statistics (INE) (9). Promoting quality of life in this population is now a priority for healthcare researchers.

In our society, loneliness, depression, and anxiety are common among older adults. Malnutrition is also a very frequent condition among the elderly and constitutes a significant burden on healthcare and social systems (10).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Depression

时间窗: 4 months

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

Anxiety

时间窗: 4 months

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

Social support

时间窗: 4 months

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

Health-Related Quality of Life

时间窗: 4 months

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.

次要结局

  • 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)
  • Satisfaction with the intervention(4 months)
  • Adherence to the intervention(4 months)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Ruiz Comellas

PHD

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

研究点 (2)

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