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临床试验/NCT07461883
NCT07461883已完成不适用

Improving Food Literacy in the Elderly Through an eHealth Education Program Based on Personalized Nutrition

CEU San Pablo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月8日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Food literacy score assessed with the Food Literacy Questionnaire for Spanish older adults (FLQ-e)

研究概览

简要总结

This controlled trial aims to assess the impact of personalization and digitalization on the development of skills related to food agency, safe dietary habits, and healthy lifestyles in a cohort of 120 free-living individuals aged 65 years and older. Participants are assigned to intervention and control groups to evaluate the effectiveness of tailored interventions leveraging personalized and digital approaches.

详细描述

The "proof of principle" study was a one-year, three-arm controlled trial conducted in free-living men and women over 65 years old living in Madrid, Spain. The study aimed to answer the following questions:

i) Did personalization of dietary and lifestyle advice improve diet and food literacy, promoting healthy lifestyles? ii) Was the use of a specifically designed mobile app effective in assisting and/or motivating study participants to make and sustain appropriate health-promoting changes? To answer these questions, participants were assigned to a Control group (Level 0) or to one of two intervention groups for a one-year period.

Participants were recruited in Cultural associations in Fuenlabrada, a town in southern Madrid. A cluster sampling was carried out, randomly selecting three centers from among the eight Cultural Centers for the Elderly existing in Fuenlabrada. One center acted as a control center, while the other two provided the sample of seniors who were the subjects of the interventions (one center for L1 (personalization) and another for L2 (personalization and digitalization)). Adequate distance between the selected centers was ensured to avoid cross-contamination between participants. Participation in the project was offered to all users of the selected centers who met the inclusion criteria, up to the number of participants required for the project.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 65 years and over
  • Non-institutionalized
  • Retired from main professional activity or part-time working
  • Smartphone user.

排除标准

  • Presence of a severe or limiting disease (such as cancer, dementia, advanced Parkinson's disease, or any other serious pathological condition)
  • Use of a pacemaker or implantable automatic defibrillator
  • Adherence to a specific prescribed diet for any reason other than a low-sodium, low-fat, or weight-control diet.
  • Diagnosis of digestive disorders such as celiac disease or Crohn's disease, or any metabolic disease or condition that alters nutritional requirements.
  • Use of enteral or parenteral nutritional support at home.
  • Presence of cognitive or psychomotor impairment.
  • Expectation of institutionalization.
  • Consumption of more than five main meals per week outside the home

研究组 & 干预措施

Level 0 (Control group, L0)

Active Comparator

干预措施: L0: non personalized dietary and lifestyle advice (Behavioral)

Level 1 (L1). Personalized Nutrition Group

Experimental

干预措施: L1: personalized dietary and lifestyle advice (Behavioral)

Level 2 (L2). Personalized and digitalized group

Experimental

干预措施: L2: personalized dietary and lifestyle advice and digitalization (Behavioral)

结局指标

主要结局

Food literacy score assessed with the Food Literacy Questionnaire for Spanish older adults (FLQ-e)

时间窗: From enrollment to the end of the intervention after 12 months

The Food Literacy Questionnaire for Spanish older adults (FLQ-e) consists of 41 items covering five domains of food literacy: (1) basic healthy eating, (2) label consultation and food selection, (3) meal planning and budgeting, (4) food safety, preparation and cooking, and (5) awareness of the influence of food on personal wellbeing. The questionnaire generates a total food literacy score ranging from 0 to 123 points. Based on this score, participants are classified into three levels of food literacy: low (0-41 points), medium (42-82 points), and high (83-123 points).

次要结局

  • Dietary intake assessed by 3-day dietary record and nutrient analysis using DIAL software(From enrollment to the end of the intervention at 12 months)
  • Physical activity level assessed with the International Physical Activity Questionnaire - Short Version (IPAQ-sv)(From enrollment to the end of the intervention at 12 months)

研究者

发起方
CEU San Pablo University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rocio de la Iglesia

Professor, PhD, nutritionist

CEU San Pablo University

研究点 (1)

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