Asking People With Psoriasis About Lifestyle and Eating

NCT05448352 | Completed

• 1 other identifier: Worktribe ref 1121143
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Diet; Lifestyle; Sleep; Physical Acitivty; Wellbeing

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  4 day 24-hour dietary recall

Secondary Outcomes (8)

• Sleep

  Baseline

• Physical Activity (PA)

  Baseline

• Alcohol

  Baseline

• Smoking

  Baseline

• Meal timings

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adults (18 years of age or older) Dermatologist diagnosis of psoriasis Residents in the United Kingdom (UK) Fluent in English

You may not qualify if:

• Minors (17 years of age or younger) Not medically diagnosed with Psoriasis Non-UK residents

Sponsors & Collaborators

• King's College London: lead
• Psoriasis Association: collaborator

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: July 7, 2022
• Study Start: June 18, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: January 26, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)