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

Primary Purpose

Frailty Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nutrition education
nutritional counseling
Sponsored by
Instituto Tecnologico y de Estudios Superiores de Monterey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty Syndrome

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    nutritional counseling group

    group without nutritional counseling

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Frailty syndrome
    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

    Secondary Outcome Measures

    Protein intake
    Intake of grams of protein per day from animal or vegetable sources. It will be evaluated through a 24-hour recall.
    Malnutrition
    Malnutrition is a lack of calories or one or more essential nutrients. It will be measured through the Mini Nutritional Assessment long form (MNA-LF), a screening tool to help identify elderly patients who are malnourished or at risk of malnutrition. The tool consists of a 18-item in the long form scale.
    Handgrip strength
    It is the maximum isometric strength of the hand and forearm muscles.. It will be evaluated through the pressure force of the participant's dominant hand estimated through a dynamometer and whose cut-off points refer to a decrease in force when it is below 30 kg in men or 20 kg in women.
    sedentary activities
    Those activities that people do sitting or reclining, while we are awake, and that use very little energy. These will be evaluated through self-report of sedentary activities Adapted from the ASAQ Questionnaire (Adolescent Sedentary Activity Questionnaire)

    Full Information

    First Posted
    March 8, 2022
    Last Updated
    March 21, 2022
    Sponsor
    Instituto Tecnologico y de Estudios Superiores de Monterey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05304429
    Brief Title
    Application of a Nutritional Counseling Program on the Frailty of Older Adults in the Mexican Population
    Official Title
    Application of a Nutritional Counseling Program on the Frailty of Older Adults in the Mexican Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 29, 2022 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto Tecnologico y de Estudios Superiores de Monterey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. Nutritional education was carried out in group sessions of 40 minutes having a total of 10 workshops which provided practical theoretical tools to each of the behaviors to be monitored, in this way each workshop addressed a specific behavior. The intervention will be aimed at qualitatively and quantitatively modifying eating habits, emphasizing protein consumption and modifying physical activity habits, limiting sedentary behaviors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frailty Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Clinical trial with intervention group and control group
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nutritional counseling group
    Arm Type
    Experimental
    Arm Description
    This group will have nutrition education sessions every fifteen days and will keep track of 10 healthy behaviors through goal setting and self-monitoring.
    Arm Title
    group without nutritional counseling
    Arm Type
    No Intervention
    Arm Description
    This group will have sessions every fifteen days of reading, knitting and other activities unrelated to health.
    Intervention Type
    Behavioral
    Intervention Name(s)
    nutrition education
    Intervention Description
    Educational sessions with topics that will address the management and prevention of frailty syndrome focusing on protein intake and physical activity
    Intervention Type
    Behavioral
    Intervention Name(s)
    nutritional counseling
    Intervention Description
    nutritional counseling system based on the com-b model through three strategies: goal setting, self-monitoring and social support
    Primary Outcome Measure Information:
    Title
    Frailty syndrome
    Description
    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
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Protein intake
    Description
    Intake of grams of protein per day from animal or vegetable sources. It will be evaluated through a 24-hour recall.
    Time Frame
    6 months
    Title
    Malnutrition
    Description
    Malnutrition is a lack of calories or one or more essential nutrients. It will be measured through the Mini Nutritional Assessment long form (MNA-LF), a screening tool to help identify elderly patients who are malnourished or at risk of malnutrition. The tool consists of a 18-item in the long form scale.
    Time Frame
    6 months
    Title
    Handgrip strength
    Description
    It is the maximum isometric strength of the hand and forearm muscles.. It will be evaluated through the pressure force of the participant's dominant hand estimated through a dynamometer and whose cut-off points refer to a decrease in force when it is below 30 kg in men or 20 kg in women.
    Time Frame
    6 months
    Title
    sedentary activities
    Description
    Those activities that people do sitting or reclining, while we are awake, and that use very little energy. These will be evaluated through self-report of sedentary activities Adapted from the ASAQ Questionnaire (Adolescent Sedentary Activity Questionnaire)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mariana Cecilia Orellana, master degree
    Phone
    +52 3313446872
    Email
    m.orellana@tec.mx
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claudia Madeleine Hunot, PhD
    Phone
    +52 3331154831
    Email
    claudia.hunot@academicos.udg.mx

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24402390
    Citation
    Nykanen I, Rissanen TH, Sulkava R, Hartikainen S. Effects of individual dietary counseling as part of a comprehensive geriatric assessment (CGA) on nutritional status: a population-based intervention study. J Nutr Health Aging. 2014 Jan;18(1):54-8. doi: 10.1007/s12603-013-0342-y.
    Results Reference
    background
    PubMed Identifier
    28717811
    Citation
    Andersson J, Hulander E, Rothenberg E, Iversen PO. Effect on Body Weight, Quality of Life and Appetite Following Individualized, Nutritional Counselling to Home-Living Elderly after Rehabilitation - An Open Randomized Trial. J Nutr Health Aging. 2017;21(7):811-818. doi: 10.1007/s12603-016-0825-8.
    Results Reference
    background
    PubMed Identifier
    16813773
    Citation
    Faber MJ, Bosscher RJ, Chin A Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: A multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006 Jul;87(7):885-96. doi: 10.1016/j.apmr.2006.04.005.
    Results Reference
    background
    PubMed Identifier
    28183809
    Citation
    Gardner B, Jovicic A, Belk C, Kharicha K, Iliffe S, Manthorpe J, Goodman C, Drennan VM, Walters K. Specifying the content of home-based health behaviour change interventions for older people with frailty or at risk of frailty: an exploratory systematic review. BMJ Open. 2017 Feb 9;7(2):e014127. doi: 10.1136/bmjopen-2016-014127.
    Results Reference
    background
    PubMed Identifier
    28273591
    Citation
    Fernandez-Barres S, Garcia-Barco M, Basora J, Martinez T, Pedret R, Arija V; Project ATDOM-NUT group. The efficacy of a nutrition education intervention to prevent risk of malnutrition for dependent elderly patients receiving Home Care: A randomized controlled trial. Int J Nurs Stud. 2017 May;70:131-141. doi: 10.1016/j.ijnurstu.2017.02.020. Epub 2017 Feb 23.
    Results Reference
    background
    Links:
    URL
    http://www.enasem.org/images/MHASFactSheet_Frailty_SPANISH.pdf
    Description
    findings of the national study of health and aging in Mexico

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

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