The Effects of Weight Loss on Psoriatic Arthritis

NCT05393141 | Completed

• 1 other identifier: HU-SO-2022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. This study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach (BETY-Bilişsel Egzersiz Terapi Yöntemi) interventions on symptoms. Accordingly, 45 overweight/obese subjects with PSA aged 20-65 years will divide into "diet", "diet+bety", and "control" groups. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at the end of the study.

Conditions

Psoriatic Arthritis; Obesity

Keywords

psoriatic arthritis; diet; biopsychosocial exercise

Outcome Measures

Primary Outcomes (2)

• Weight Loss

  BMI (kilogram/metre2(kg/m2))

  At the end of 3 months

• DAPSA score

  The score ranges from 0 to 50 points, with increased score reflect more discomfort

  At the end of 3 months

Secondary Outcomes (1)

• Quality of Life Score

  At the end of 3 months

Study Arms (3)

diet group

EXPERIMENTAL

weight loss diet intervention for 12 weeks

Behavioral: diet and biopsychosocial exercise intervention

diet+bety group

EXPERIMENTAL

weight loss diet intervention for 12 weeks and exercise-based biopsychosocial approach (Cognitive Exercise Therapy Approach-BETY) intervention for 12 weeks

Behavioral: diet and biopsychosocial exercise intervention

control group

NO INTERVENTION

no intervention, control

Interventions

diet and biopsychosocial exercise intervention BEHAVIORAL

dietary intervention: biopsychosocial exercise intervention:

diet group; diet+bety group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• overweight/obese
• diagnosed with PSA

You may not qualify if:

• pregnancy or lactation

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Sümeyra Öteleş

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher of the Hacettepe University

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: January 30, 2022
• Primary Completion: August 15, 2022
• Study Completion: October 15, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)