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
About this trial
This is an interventional prevention trial for Frailty Syndrome
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
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
NCT ID
NCT05304429
First Posted
March 8, 2022
Last Updated
March 21, 2022
Sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
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
Learn more about this trial
Application of a Nutritional Counseling Program on the Frailty of Older Adults in the Mexican Population
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