Life Style and Food Habits Questionnaire in the Portugues... | NCT01715870

Studies
Life Style and Food Habits Questionnaire in the Portuguese Population Aged 55 or More

NCT01715870

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Status

Completed

Last Update Posted

Oct 9, 2015Estimated

Enrollment

2,000Actual

Phase

Not provided

Conditions

Age Related Macular Degeneration

Interventions

Life style and food habits questionnaire

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Oct 25, 2012

First Posted Date

Oct 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2015

Last Update Posted Date

Oct 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rufino Silva, MD, PhD, Association for Innovation and Biomedical Research on Light and ImagePrincipal Investigator

Lead Sponsor

Association for Innovation and Biomedical Research on Light and ImageOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Population of the "Epidemiological study on AMD".			Behavioral: Life style and food habits questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Life style and food habits questionnaire	Behavioral		Population of the "Epidemiological study on AMD".

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.)	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

- None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rufino M Silva, MD, PhD	Association for Innovation and Biomedical Research on Light and Image	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIBILI		Coimbra	Coimbra District	3000-548	Portugal

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37580831	Derived	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.

ID	Term
D008268	Macular Degeneration
D005247	Feeding Behavior

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D001522	Behavior, Animal