Clinical trial NCT05304429: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty Syndrome
Lead sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial with intervention group and control group
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Frailty syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Protein intake
timeFrame: 6 months
measure: Malnutrition
timeFrame: 6 months
measure: Handgrip strength
timeFrame: 6 months
measure: sedentary activities
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.