PsoriasisAPPLENCT05448352
Asking People With Psoriasis About Lifestyle and Eating
An observational study of Psoriasis, run by King's College London at 1 site in United Kingdom.
Trial summary
The APPLE Study aims to understand if specific diet and lifestyle patterns are present in individuals with psoriasis and if these factors are correlated with psoriasis severity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 358 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2022to 8 Jan 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will comprise of adults, with a medical diagnosis of psoriasis living in the UK and who are fluent in the English language. This is a nationwide study to obtain responses from participants representative of the psoriasis population in the UK.
Who may be able to join
- Adults (18 years of age or older) Dermatologist diagnosis of psoriasis Residents in the United Kingdom (UK) Fluent in English
Who cannot join
- Minors (17 years of age or younger) Not medically diagnosed with Psoriasis Non-UK residents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The APPLE Study; a Cross-sectional Study Exploring Diet, Life-style Patterns and Psoriasis Severity
The APPLE Study aims to understand if specific diet and lifestyle patterns are present in individuals with psoriasis and if these factors are correlated with psoriasis severity.
Read the detailed description
Prospective participants will be invited to read an information sheet and provide informed consent. Once informed consent is obtained, participants will be screened for eligibility with a short online screening questionnaire. Upon successful completion, participants will be directed to start the online multiple-choice survey with questions on psoriasis, diet and lifestyle patterns and complete a 4-day diet diary.
- Conditions
- Psoriasis
- Keywords
- Diet, Lifestyle, Sleep, Physical Acitivty, Wellbeing
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
self-assessed Simplified Psoriasis Index
The self-assessed Simplified Psoriasis Index measures psoriasis severity as a joint score of 3 categories.
Severity; a 3-point scale will measure the severity of skins lesions on 10 body parts. 0=minimal, +/-=noticeable. + =extensive. A 5-point scale ranging from 0=clear to 5=intensely inflamed skin will measure the overall state of psoriasis.
Psychosocial; a 10 point scale ranging from 0=not at all to 10=very much will indicate the extent to which psoriasis is affecting day-to-day life.
Intervention; participants will need to indicate each psoriasis treatment that is being received. 1 point per treatment.
The sa-PSI will generate a total score out of 70. The higher the score, the greater the severity of psoriasis.
Measured: Baseline
The Dermatology Life Quality Index (DLQI)
This index measures the impact of psoriasis on day-to-day routines as well as on psychological and social fronts. Responses to questions are scored as follows: very much (3 points), a lot (2 points), a little (1 point), not at all/not relevant (0 points).
The DLQI provides a score between 0-30. The score range is interpreted as follows: 0-1 points = no effect at all on the participants life, 2-5 points = small effect on participant's life, 6-10 points = moderate effect on participant's life, 11-20 = very large effect on participant's life and 21-30 = extremely large effect on participant's life.
Measured: Baseline
Diet
The Twins United Kingdom (TwinsUK) modified European Prospective Investigation into Cancer Food Frequency Questionnaire (EPIC FFQ) will assess dietary intake.
This FFQ will provide an overview of the consumption of 131- food items over the past 12 months. Each food item will be rated on a 9 point scale as follows: Never or less than once a month, 1-3 times per month, Once a week, 2-4 per week, 5-6 per week, Once a day, 2-3 per day, 4-5 per day and 6+ per day.
Measured: Baseline
Diet
Nutrient consumption will be examined using the Intake24 (https://intake24.co.uk/). This is dietary assessment tool in which participants will record their food intake over the past 24 hours. The results obtained from the Intake24 will provide a detailed breakdown of the total calories, macronutrients and micronutrients consumed.
Measured: 4 day 24-hour dietary recall
Secondary outcomes (8)
Sleep
Questions from the Pittsburgh Sleep Quality Index will be used to evaluate sleep quality, latency and duration.
Sleep quality: is measured on a 4-point scale ranging from very bad to very good.
Sleep latency: participants will indicate the number of minutes taken to fall asleep on a weekday and weekend day. The 6-point scale ranges from 0-10 minutes to 60+ minutes.
Sleep duration: participants will indicate the number of hours of actual sleep that are obtained on a weekday/weekend day.
Measured: Baseline
Physical Activity (PA)
The International Physical Activity Questionnaire (IPAQ) categorises PA into vigorous intensity, moderate intensity and walking. The frequency (number of days/week) and the duration (number of hours) for each PA category will determine the participant's PA level:
Health Enhancing Physical Activity (HEPA)=vigorous intensity physical activity is undertaken on at least 3 days/ week with a minimum of 1500 metabolic equivalent (MET) minutes/week or with 7 or more days of any combination of walking, moderate or vigorous intensity activities with a minimum of 3000 MET minutes/week.
Minimally active (any one of the following)=3 or more days of vigorous activity with at least 20 minutes/day, 5 or more day of moderate intensity or walking at least 30 minutes/day, or 5 or more days of combination of walking, moderate or vigorous intensity activities with a minimum of 600 MET minutes/week.
Inactive=no activity is reported or if some activity is reported but does not meet the above criteria.
Measured: Baseline
Alcohol
The frequency and units of alcohol intake will be examined using the Alcohol Use Disorders Identification Test Consumption (AUDIT-C).
Measured: Baseline
Smoking
Smoking status will be evaluated as smoker, non-smoker or ex-smoker.
Measured: Baseline
Meal timings
Meal timings will be captured using the Food Timing Questionnaire.
Measured: Baseline
Demographic characteristics
The demographic characteristics assessed include age, gender and ethnicity.
Measured: Baseline
General Health
General health will be examined based on the presence of health conditions such as obesity, cardiovascular disease, diabetes etc.
Measured: Baseline
Dietary habits
Dietary habits will be evaluated based on the inclusion and exclusion of food items from diet, beliefs around diets and following specific diets as means to improve psoriasis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start18 Jun 2022
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Psoriasis Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448352
- Sponsor's protocol ID
- Worktribe ref 1121143
- Acronym
- APPLE
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The APPLE Study; a Cross-sectional Study Exploring Diet, Life-style Patterns and Psoriasis Severity
- ClinicalTrials.gov ID
- NCT05448352
- Acronym / sponsor ID
- APPLE / Worktribe ref 1121143
- Conditions
- Psoriasis
- Keywords
- Diet, Lifestyle, Sleep, Physical Acitivty, Wellbeing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Psoriasis Association
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 7 Jul 2022 (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.
The APPLE Study aims to understand if specific diet and lifestyle patterns are present in individuals with psoriasis and if these factors are correlated with psoriasis severity.
Detailed description
Prospective participants will be invited to read an information sheet and provide informed consent. Once informed consent is obtained, participants will be screened for eligibility with a short online screening questionnaire. Upon successful completion, participants will be directed to start the online multiple-choice survey with questions on psoriasis, diet and lifestyle patterns and complete a 4-day diet diary.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise of adults, with a medical diagnosis of psoriasis living in the UK and who are fluent in the English language. This is a nationwide study to obtain responses from participants representative of the psoriasis population in the UK.
Key inclusion criteria (1 listed)
- Adults (18 years of age or older) Dermatologist diagnosis of psoriasis Residents in the United Kingdom (UK) Fluent in English
Key exclusion criteria (1 listed)
- Minors (17 years of age or younger) Not medically diagnosed with Psoriasis Non-UK residents
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
self-assessed Simplified Psoriasis Index
Time frame: Baseline
The self-assessed Simplified Psoriasis Index measures psoriasis severity as a joint score of 3 categories. Severity; a 3-point scale will measure the severity of skins lesions on 10 body parts. 0=minimal, +/-=noticeable. + =extensive. A 5-point scale ranging from 0=clear to 5=intensely inflamed skin will measure the overall state of psoriasis. Psychosocial; a 10 point scale ranging from 0=not at all to 10=very much will indicate the extent to which psoriasis is affecting day-to-day life. Intervention; participants will need to indicate each psoriasis treatment that is being received. 1 point per treatment. The sa-PSI will generate a total score out of 70. The higher the score, the greater the severity of psoriasis.
The Dermatology Life Quality Index (DLQI)
Time frame: Baseline
This index measures the impact of psoriasis on day-to-day routines as well as on psychological and social fronts. Responses to questions are scored as follows: very much (3 points), a lot (2 points), a little (1 point), not at all/not relevant (0 points). The DLQI provides a score between 0-30. The score range is interpreted as follows: 0-1 points = no effect at all on the participants life, 2-5 points = small effect on participant's life, 6-10 points = moderate effect on participant's life, 11-20 = very large effect on participant's life and 21-30 = extremely large effect on participant's life.
Diet
Time frame: Baseline
The Twins United Kingdom (TwinsUK) modified European Prospective Investigation into Cancer Food Frequency Questionnaire (EPIC FFQ) will assess dietary intake. This FFQ will provide an overview of the consumption of 131- food items over the past 12 months. Each food item will be rated on a 9 point scale as follows: Never or less than once a month, 1-3 times per month, Once a week, 2-4 per week, 5-6 per week, Once a day, 2-3 per day, 4-5 per day and 6+ per day.
Diet
Time frame: 4 day 24-hour dietary recall
Nutrient consumption will be examined using the Intake24 (https://intake24.co.uk/). This is dietary assessment tool in which participants will record their food intake over the past 24 hours. The results obtained from the Intake24 will provide a detailed breakdown of the total calories, macronutrients and micronutrients consumed.
8 secondary outcomes
Sleep
Time frame: Baseline
Physical Activity (PA)
Time frame: Baseline
Alcohol
Time frame: Baseline
Smoking
Time frame: Baseline
Meal timings
Time frame: Baseline
Demographic characteristics
Time frame: Baseline
General Health
Time frame: Baseline
Dietary habits
Time frame: Baseline
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 26 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psoriasis, run by King's College London at 1 site in United Kingdom.
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 1 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 26 Jan 2024. 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 United Kingdom. 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?
self-assessed Simplified Psoriasis Index (time frame: Baseline). The study lists 4 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 26 Jan 2024.