Age Related Macular DegenerationNCT01715870
Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More
An observational study of Age Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
The study population will be selected from the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal photographic grading (current gold standard for AMD assessment) was performed to confirm AMD diagnostic. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Life style and food habits questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2012to Apr 2014
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects that participated in the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) will be invited to answer a validated life style and food habits questionnaire.
Who may be able to join
- Subjects included in the Epidemiologic Study (Protocol N. CC-01-2009). (Subjects aged over 55 years-old included in health care units of Mira or Lousã).
- Written Informed Consent Form signed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More.
The study population will be selected from the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal photographic grading (current gold standard for AMD assessment) was performed to confirm AMD diagnostic. This study provides a population-based sample in which precise and contemporary information on the frequency of nutritional and lifestyle risk factors will be collected, enabling to evaluate whether the separate and/or joint effects of these factors, if found significant, are likely to have a major public health impact in terms of AMD.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Life style and food habits questionnaire
- Keywords
- Age related macular degeneration, Food habits, Life style, Risk factors, questionnaire
- Medical subject headings
- Macular Degeneration, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life style and food habits questionnaireBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Population of the "Epidemiological study on AMD". | Not described Receives: Behavioral: Life style and food habits questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life style and food habits questionnaire.
Life style and food habits questionnaire. (This questionnaire assesses life style habits such as physical exercise and smoking habits and quantifies dietary intake.)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rufino Silva, Association for Innovation and Biomedical Research on Light and Image
- Investigators
- Rufino M Silva, MD, PhD, Principal investigator, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715870
- Sponsor's protocol ID
- 4C-2012-04
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2012
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Barreto P, Farinha C, Coimbra R, Cachulo ML, Melo JB, Lechanteur Y, Hoyng CB, Cunha-Vaz J, Silva R. Interaction between genetics and the adherence to the Mediterranean diet: the risk for age-related macular degeneration. Coimbra Eye Study Report 8. Eye Vis (Lond). 2023 Aug 14;10(1):38. doi: 10.1186/s40662-023-00355-0.
PubMed 37580831
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More.
- ClinicalTrials.gov ID
- NCT01715870
- Acronym / sponsor ID
- 4C-2012-04
- Conditions
- Age Related Macular Degeneration
- Keywords
- Age related macular degeneration, Food habits, Life style, Risk factors, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- 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.
The study population will be selected from the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal photographic grading (current gold standard for AMD assessment) was performed to confirm AMD diagnostic. This study provides a population-based sample in which precise and contemporary information on the frequency of nutritional and lifestyle risk factors will be collected, enabling to evaluate whether the separate and/or joint effects of these factors, if found significant, are likely to have a major public health impact in terms of AMD.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population of the "Epidemiological study on AMD". | – | Behavioral: Life style and food habits questionnaire |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that participated in the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) will be invited to answer a validated life style and food habits questionnaire.
Key inclusion criteria (2 listed)
- Subjects included in the Epidemiologic Study (Protocol N. CC-01-2009). (Subjects aged over 55 years-old included in health care units of Mira or Lousã).
- Written Informed Consent Form signed.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life style and food habits questionnaire | Behavioural | Population of the "Epidemiological study on AMD". |
Primary outcome
Life style and food habits questionnaire.
Time frame: 2 years
Life style and food habits questionnaire. (This questionnaire assesses life style habits such as physical exercise and smoking habits and quantifies dietary intake.)
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 9 Oct 2015.
- Derived from this study: PubMed 37580831Barreto P, Farinha C, Coimbra R, Cachulo ML, Melo JB, Lechanteur Y, Hoyng CB, Cunha-Vaz J, Silva R. Interaction between genetics and the adherence to the Mediterranean diet: the risk for age-related macular degeneration. Coimbra Eye Study Report 8. Eye Vis (Lond). 2023 Aug 14;10(1):38. doi: 10.1186/s40662-023-00355-0.
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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.
Rufino M Silva, MD, PhD principal investigator
Association for Innovation and Biomedical Research on Light and Image
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 Age Related Macular Degeneration, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
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 2 inclusion and 1 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 9 Oct 2015. 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 Portugal. 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?
Life style and food habits questionnaire. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715870, which also lists 1 linked publication.
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 9 Oct 2015.