Application of a Nutritional Counseling Program on the Frailty of Older Adults in the Mexican Population
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
April 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedMarch 31, 2022
March 1, 2022
4 months
March 8, 2022
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (4)
Protein intake
6 months
Malnutrition
6 months
Handgrip strength
6 months
sedentary activities
6 months
Study Arms (2)
nutritional counseling group
EXPERIMENTALThis group will have nutrition education sessions every fifteen days and will keep track of 10 healthy behaviors through goal setting and self-monitoring.
group without nutritional counseling
NO INTERVENTIONThis group will have sessions every fifteen days of reading, knitting and other activities unrelated to health.
Interventions
Educational sessions with topics that will address the management and prevention of frailty syndrome focusing on protein intake and physical activity
nutritional counseling system based on the com-b model through three strategies: goal setting, self-monitoring and social support
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 24402390BACKGROUNDAndersson 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.
PMID: 28717811BACKGROUNDFaber 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.
PMID: 16813773BACKGROUNDGardner 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.
PMID: 28183809BACKGROUNDFernandez-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.
PMID: 28273591BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Proffessor
Study Record Dates
First Submitted
March 8, 2022
First Posted
March 31, 2022
Study Start
April 29, 2022
Primary Completion
September 1, 2022
Study Completion
November 1, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share