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Eating Habits and Lifestyle Profile of an Italian Aging Cohort

28 de mayo de 2021 actualizado por: Hellas Cena, University of Pavia

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.

Descripción general del estudio

Descripción detallada

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%.

Tipo de estudio

De observación

Inscripción (Actual)

600

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Lombardia
      • Pavia, Lombardia, Italia, 27100
        • University of Pavia

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Free-living elderly

Free-living elderly over the age of 65 living in Metropolitan Area of Milan, in apparent good health conditions.

Male and Female

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assessment of the socio-demographic characteristics
Periodo de tiempo: 1 day
Age, Educational level, family status, food safety, food security.
1 day
Assessment of eating habits
Periodo de tiempo: 1 day
Eating habits: evaluated with the Food Habit (FHQ) section of questionnaire by Turconi et al. (2003), to investigate the eating habits related to daily number of meals, consumption of the main food groups (fruit, vegetables, etc) and soft drinks or alcoholic beverages. Each question has the following response: always, often, sometimes, never. The score assigned to each response ranged from 0 to 3, with the maximum score assigned to the healthiest one and the minimum score to the least healthy one according to the Italian National Dietary Guidelines (2018).
1 day
Assessment of smoking habits
Periodo de tiempo: 1 day
Smoking habits: evaluated with specific semi-quantitative questions such as: "Are you smoker, no-smoker or former smoker?"; "How long have you been smoking?", "How old were you when you started smoking?" and "How many cigarettes do you smoke daily?" in current smokers; "How many years have passed since the last cigarette?" and "How many cigarettes per day did you use to smoke?" in former smokers. The minimum score was assigned to the healthiest habit.
1 day
Assessment of Physical activity level
Periodo de tiempo: 1 day
Physical activity level evaluated with the International Physical Activity Questionnaires (IPAQ) - Short Form. The specific activity levels assessed are walking, moderate-intensity activities and vigorous-intensity activities. The scores are expressed in Metabolic Equivalent of task -minutes/week.The total score includes the sum of the duration (in minutes) and the frequency (days) of the three dimensions analyzed (walking, activity of moderate intensity and vigorous intensity). Higher number of MET per week relate with higher level of physical activity.
1 day
Assessment of Sleep Quality
Periodo de tiempo: 1 day
Sleep Quality: evaluated with the Italian version of Pittsburgh Sleep Quality Index (PSQI), validated by Curcio et al (2011). It's a 19-item questionnaire investigating seven domains of sleep (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction). A global score, calculated from the score of each domains, higher than 5 is considered as an indicator of bad sleep quality.
1 day
Nutritional assessment: weight status
Periodo de tiempo: 1 day
Measurement of: body weight in kilograms; height in centimeters, evaluated with prediction formula height-knee by Donini et al (2000); weight and height will be combined to report BMI in kg/m^2 to evaluate the weight status (underweight, normal, overweight, obesity);
1 day
Nutritional assessment: fat distribution
Periodo de tiempo: 1 day
Measurement of: waist circumference in centimeters; hip circumference in centimeters; waist and hip will be combined to report waist-hip ratio (WHR) and waist and height will be combined to report waist-height ratio (WHtR), both as indicators of fat distribution and metabolic diseases risk.
1 day
Nutritional assessment: other antropometric parameters
Periodo de tiempo: 1 day
Measurement of calf circumference in centimeters, as inidcator of muscle mass. Measurement of neck circumference in centimeters, as indicator of fat distribution and metabolic diseases risk.
1 day
Nutritional assessment: arm circumference and triceps skinfold thickness
Periodo de tiempo: 1 day
Mesurement of: arm circumference in centimeters, as inidcator of muscle mass; triceps skinfold thickness in millimeters, as indicator of fatty mass; upper arm circumference and triceps fold will be combined to report the upper arm area in millimeters^2, upper arm muscle area in millimeters^2, upper arm fat area in millimeters^2.
1 day
Nutritional assessment: muscle strenght
Periodo de tiempo: 1 day
Measurement of hand-grip in kilograms, to assess muscle strength
1 day
Nutritional assessment: body composition
Periodo de tiempo: 1 day
Assessment of body composition with bioelectrical impedance analysis (BIVA).
1 day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence to Italian National Dietary Guidelines
Periodo de tiempo: 1 day
Assess adherence to adequate eating habits from the analysis of Food Habits questionnaire according to the Italian National Dietary Guidelines.
1 day
Identify possible nutritional deficiencies
Periodo de tiempo: 1 day
Identify possible nutritional deficiencies from the analysis of the Food Habits questionnaire
1 day
Lifestyle and nutritional status
Periodo de tiempo: 1 day
Influence of eating habits analyzed with FHQ, sleep quality analyzed with PSQI, and physical activity level analyzed with IPAQ on nutritional status (all antropometric and body composition parameters collected).
1 day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Hellas Cena, University of Pavia

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2017

Finalización primaria (Actual)

31 de marzo de 2021

Finalización del estudio (Actual)

31 de marzo de 2021

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2020

Publicado por primera vez (Actual)

26 de mayo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 13052020
  • CUP E47F17000020009 (Otro número de subvención/financiamiento: Regione Lombardia - POR FESR 2014-2020)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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