AgingNCT04401930
Eating Habits and Lifestyle Profile of an Italian Aging Cohort
An observational study of Aging and Healthy Aging, run by University of Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy Aging, Life Style
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2017to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- Age: over 65
- free-living
- autonomous, self sufficient
- acceptance and sign of informed consent
Who cannot join
- Age: under 65
- living in: nursing home, Extended Care
- hospitalized
- non autonomous, non self sufficient
- without acceptance and sign of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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%.
- 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
- Medical subject headings
- Feeding Behavior, Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the socio-demographic characteristics
Age, Educational level, family status, food safety, food security.
Measured: 1 day
Assessment of eating habits
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).
Measured: 1 day
Assessment of smoking habits
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.
Measured: 1 day
Assessment of Physical activity level
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.
Measured: 1 day
Assessment of Sleep Quality
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.
Measured: 1 day
Nutritional assessment: weight status
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);
Measured: 1 day
Nutritional assessment: fat distribution
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.
Measured: 1 day
Nutritional assessment: other antropometric parameters
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.
Measured: 1 day
Nutritional assessment: arm circumference and triceps skinfold thickness
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.
Measured: 1 day
Nutritional assessment: muscle strenght
Measurement of hand-grip in kilograms, to assess muscle strength
Measured: 1 day
Nutritional assessment: body composition
Assessment of body composition with bioelectrical impedance analysis (BIVA).
Measured: 1 day
Secondary outcomes (3)
Adherence to Italian National Dietary Guidelines
Assess adherence to adequate eating habits from the analysis of Food Habits questionnaire according to the Italian National Dietary Guidelines.
Measured: 1 day
Identify possible nutritional deficiencies
Identify possible nutritional deficiencies from the analysis of the Food Habits questionnaire
Measured: 1 day
Lifestyle and nutritional status
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Nov 2017
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Principal investigator, Hellas Cena, University of Pavia
- Investigators
- Hellas Cena, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401930
- Sponsor's protocol ID
- 13052020
- Other IDs
- CUP E47F17000020009
- Status last verified
- May 2021
- First submitted
- 15 May 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Habits and Lifestyle Profile of an Italian Aging Cohort
- ClinicalTrials.gov ID
- NCT04401930
- Acronym / sponsor ID
- 13052020
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- Age: over 65
- free-living
- autonomous, self sufficient
- acceptance and sign of informed consent
Key exclusion criteria (5 listed)
- Age: under 65
- living in: nursing home, Extended Care
- hospitalized
- non autonomous, non self sufficient
- without acceptance and sign of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the socio-demographic characteristics
Time frame: 1 day
Age, Educational level, family status, food safety, food security.
Assessment of eating habits
Time frame: 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).
Assessment of smoking habits
Time frame: 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.
Assessment of Physical activity level
Time frame: 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.
Assessment of Sleep Quality
Time frame: 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.
Nutritional assessment: weight status
Time frame: 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);
Nutritional assessment: fat distribution
Time frame: 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.
Nutritional assessment: other antropometric parameters
Time frame: 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.
Nutritional assessment: arm circumference and triceps skinfold thickness
Time frame: 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.
Nutritional assessment: muscle strenght
Time frame: 1 day
Measurement of hand-grip in kilograms, to assess muscle strength
Nutritional assessment: body composition
Time frame: 1 day
Assessment of body composition with bioelectrical impedance analysis (BIVA).
3 secondary outcomes
Adherence to Italian National Dietary Guidelines
Time frame: 1 day
Identify possible nutritional deficiencies
Time frame: 1 day
Lifestyle and nutritional status
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hellas Cena principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Healthy Aging, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the socio-demographic characteristics (time frame: 1 day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.