跳至主要内容
临床试验/NCT05304429
NCT05304429Unknown不适用

Application of a Nutritional Counseling Program on the Frailty of Older Adults in the Mexican Population

Instituto Tecnologico y de Estudios Superiores de Monterey0 个研究点目标入组 80 人开始时间: 2022年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
Frailty syndrome

研究概览

简要总结

In the present study, the COM-B model is intended to be used as a central axis in the planning of the nutritional counseling intervention, since it proposes that behavioral modification is conditioned by the capacity, opportunity and motivation of the person, 3 basic components that can be addressed with nutritional education and goal-setting strategies, self-monitoring and social support.

The intervention will consist of applying nutritional counseling in older adults with frailty syndrome to measure the effect on indicators of this syndrome such as nutritional status, handgrip strength, protein consumption and physical activity.

详细描述

Clinical trial with intervention group and control group that include men and women over 60 years of age with frailty or risk of suffering it according to the frailty scale

INTERVENTION:

The COM-B system is based on 3 main pillars that appear in the initials of its name, being the C for "capacity", the O for "opportunity" and the M for "motivation". The behavior of the person is attributed to these in such a way that if they have the capacity, motivation and opportunity, the strategies used for behavior change will be more effective.

Based on this theory, the investigators support the intervention of the study in which the capacity of the participants will be developed through nutritional education, motivation through goal setting and self-monitoring, and the opportunity for social support that will be provided through this project at no cost to users of the DIF Zapopan Metropolitan Center for the Elderly.

Regarding the establishment of goals, 10 important behaviors will be worked on to prevent or combat frailty, which promote adequate protein consumption, balance in the distribution of nutrients, avoid prolonged periods of fasting by encouraging the consumption of healthy snacks, decreased consumption of ultra-processed foods, increasing the consumption of plant-based foods and performing strength exercises. The adherence to these behaviors will be self-monitored on a weekly basis through a format (see annex 4) that each person will receive and that is inspired by the strategy used by Beeken and collaborators in the "ten top tis" project where the effectiveness in behavioral modification through goal setting and self-monitoring.

研究设计

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

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women over 60 years of age
  • •That they have a normal cognitive function (more than 24 points in the minimental test)
  • •That they attend weekly the Metropolitan Center for the Elderly (DIF Zapopan)
  • •Who suffer from frailty or pre-frailty (from 1 to 5 points on the frailty scale)

排除标准

  • •Severe dysphagia
  • •Consumption of food supplements (protein powder or vitamins)
  • •Senile dementia, cognitive impairment or Alzheimer's
  • •People who are following a diet or physical activity plan prescribed by a professional

研究组 & 干预措施

nutritional counseling group

Experimental

This group will have nutrition education sessions every fifteen days and will keep track of 10 healthy behaviors through goal setting and self-monitoring.

干预措施: nutrition education (Behavioral)

nutritional counseling group

Experimental

This group will have nutrition education sessions every fifteen days and will keep track of 10 healthy behaviors through goal setting and self-monitoring.

干预措施: nutritional counseling (Behavioral)

group without nutritional counseling

No Intervention

This group will have sessions every fifteen days of reading, knitting and other activities unrelated to health.

结局指标

主要结局

Frailty syndrome

时间窗: 6 months

Geriatric syndrome characterized by a decreased ability of the body to respond to external stressors, causing in the individual: risk of falls, functional decline, disability, dependency, institutionalization and even death. For its evaluation, the frailty scale valid in Mexicans proposed by Díaz de León González in 2016 will be used. It considers 5 questions and classifies those with a score between 3 to 5 points as frail, pre-fragile between 1 and 2 and non-fragile with a score of zero. Questions: Do you feel tired most of the time? Can you walk up one flight of stairs without breaks or help? Are you able to walk 100 m without pausing and without assistance? Have more than 5 symptoms. Arthritis, diabetes, angina/heart attack, hypertension, stroke, asthma, chronic bronchitis, emphysema, osteoporosis, colorectal cancer, skin cancer, depression/anxiety, dementia, leg ulcers. Weightloss: \> 5% in the last year

次要结局

  • Handgrip strength(6 months)
  • Malnutrition(6 months)
  • sedentary activities(6 months)
  • Protein intake(6 months)

研究者

发起方
Instituto Tecnologico y de Estudios Superiores de Monterey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Cecilia Orellana Haro

Clinical Proffessor

Instituto Tecnologico y de Estudios Superiores de Monterey

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