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The Effects of Weight Loss on Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis, Obesity

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

diet and biopsychosocial exercise intervention

About this trial

This is an interventional supportive care trial for Psoriatic Arthritis focused on measuring psoriatic arthritis, diet, biopsychosocial exercise

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

overweight/obese
diagnosed with PSA

Exclusion Criteria

pregnancy or lactation

Sites / Locations

Sümeyra Öteleş

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

diet group

diet+bety group

control group

Arm Description

weight loss diet intervention for 12 weeks

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

no intervention, control

Outcomes

Primary Outcome Measures

Weight Loss

BMI (kilogram/metre2(kg/m2))

DAPSA score

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

Secondary Outcome Measures

Quality of Life Score

The score ranges from 0 to 100 points, with increased score reflecting improved quality of life

Full Information

NCT ID

NCT05393141

First Posted

May 23, 2022

Last Updated

December 4, 2022

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT05393141

Brief Title

The Effects of Weight Loss on Psoriatic Arthritis

Official Title

The Effect of Body Weight Management and Cognitive Exercise Therapy Approach on Psoriatic Arthritis Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 30, 2022 (Actual)

Primary Completion Date

August 15, 2022 (Actual)

Study Completion Date

October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. The present study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach interventions on symptoms. Fourt-five overweight/obese subjects with PSA aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups. Individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian. BETY exercise training will be given by a registered physiotherapist. The subjects will be followed for 12 weeks. 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 study completion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis, Obesity

Keywords

psoriatic arthritis, diet, biopsychosocial exercise

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diet group

Arm Type

Experimental

Arm Description

weight loss diet intervention for 12 weeks

Arm Title

diet+bety group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

No Intervention

Arm Description

no intervention, control

Intervention Type

Behavioral

Intervention Name(s)

diet and biopsychosocial exercise intervention

Intervention Description

dietary intervention: biopsychosocial exercise intervention:

Primary Outcome Measure Information:

Title

Weight Loss

Description

BMI (kilogram/metre2(kg/m2))

Time Frame

At the end of 3 months

Title

DAPSA score

Description

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

Time Frame

At the end of 3 months

Secondary Outcome Measure Information:

Title

Quality of Life Score

Description

The score ranges from 0 to 100 points, with increased score reflecting improved quality of life

Time Frame

At the end of 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: overweight/obese diagnosed with PSA Exclusion Criteria pregnancy or lactation

Facility Information:

Facility Name

Sümeyra Öteleş

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effects of Weight Loss on Psoriatic Arthritis

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