Clinical trial NCT04401930: Eating Habits and Lifestyle Profile of an Italian Aging Cohort
Official title: Eating Habits and Lifestyle Profile of an Italian Aging Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Healthy Aging
Life Style
Eating Habit
Nutritional Deficiency
Sarcopenia
Keywords: elderly
life style
eating habits
health status
body composition
sarcopenia
nutritional deficiency
aged
Lead sponsor: University of Pavia
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2020-05-26
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Free-living over 65 subjects living in Milan and surroundings, in apparent good health conditions and self sufficient, able to express their consent to participate in the study.

Brief summary: Aging is characterized by low-grade inflammatory state, supported by impairment oxidative balance and endocrine changes, leading to changes in: body composition, such as decrease in lean body mass and increase in adipose tissue; resting metabolic rate; immune function; cognitive impairment. According to the Academy of Nutrition and Dietetics all subjects over the age of 60 should be able to access to adequate nutrition and appropriate nutritional services.

In order to ensure healthy aging and to reduce effects of specific diseases, recommendations are needed for illness and disability in this population, as well as adequate physical activity and specific support programs, culturally accepted.

The aim of this study is to evaluate eating habits in term of food consumption, health state and lifestyle in a sample of free-living elderly over the age of 65, living in Milan and surroundings.

In particular, profiling of the elderly population is performed using a survey in which information are collected on methods, contexts, time and ability to buy, prepare, consume and dispose of and recycle food. Eating habits and knowledge about food are detected through the analysis of food consumption frequencies, and lifestyle by assessing the level of physical activity, quality of sleep, smoking habit. Weight status and health status are evaluated through anthropometric measurements, body composition (bioelectrical impedance) and strength test.

Other information relating to social participation and other socio-demographic variables (age, gender, family composition, socio-economic status) are collected to have a completed profiling of target population.

Achieved results will help us to identify factors on which acting to ensure healthy aging and counteract inflammaging, the chronic low-grade systemic inflammation characteristic in the aging process.

Moreover, the study allows increasing the knowledge related to the needs and requirements of the target population to determine a good food policy and to increase the elderly empowerment.

Detailed description: The study concerns the elderly population of the Milan Metropolitan Area. The aim is to identify and interpret the nutritional needs of the target population and thus implement the quality of life and the nutritional status of citizens through the evaluation of the dietary habits, health status and lifestyle of the elderly free-living.

The information is collected through a questionnaire consisting of 6 sections and includes batteries of questions and scales already validated in the literature: i) access to the points of sale; ii) consumer behavior; iii) eating habits; iv) opinions regarding accessibility; v) state of health, physical activity and sleep quality; vi) other socio-demographic information. The collected data will allow to identify different profiles of elderly people with respect to the investigated dimensions and to estimate the influence of different factors on eating habits and health status.

To complete the information collected with the questionnaire, functional and anthropmetric parameters are detected which are useful to complete the nutritional assessment of the target population. Specifically, the muscle strength, body composition, body weight, height, body circumferences, plicometry are measured, and the antripometric indices waist-height circumference ratio, waist-hip circumference ratio and arm muscle area are calculated.

SAMPLE SIZE: Based on the data on the population residing on 1 January 2017 from an Istat source, the residents of the metropolitan city of Milan aged 65 and over are 722703. The sample size was defined with the choice of a confidence level of 95% and of a confidence interval of 4%.

Eligibility criteria: Inclusion Criteria:

* Age: over 65
* free-living
* autonomous, self sufficient
* acceptance and sign of informed consent

Exclusion Criteria:

* Age: under 65
* living in: nursing home, Extended Care
* hospitalized
* non autonomous, non self sufficient
* without acceptance and sign of informed consent

Primary outcomes:
measure: Assessment of the socio-demographic characteristics
timeFrame: 1 day
measure: Assessment of eating habits
timeFrame: 1 day
measure: Assessment of smoking habits
timeFrame: 1 day
measure: Assessment of Physical activity level
timeFrame: 1 day
measure: Assessment of Sleep Quality
timeFrame: 1 day
measure: Nutritional assessment: weight status
timeFrame: 1 day
measure: Nutritional assessment: fat distribution
timeFrame: 1 day
measure: Nutritional assessment: other antropometric parameters
timeFrame: 1 day
measure: Nutritional assessment: arm circumference and triceps skinfold thickness
timeFrame: 1 day
measure: Nutritional assessment: muscle strenght
timeFrame: 1 day
measure: Nutritional assessment: body composition
timeFrame: 1 day
Secondary outcomes:
measure: Adherence to Italian National Dietary Guidelines
timeFrame: 1 day
measure: Identify possible nutritional deficiencies
timeFrame: 1 day
measure: Lifestyle and nutritional status
timeFrame: 1 day
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
state: Lombardia
Study officials:
affiliation: University of Pavia
name: Hellas Cena
role: PRINCIPAL_INVESTIGATOR
References: