NCT02028624

Brief Summary

Aim of the present study was to evaluate the effect of different lifestyle intervention administrations, in increasing adherence to the Mediterranean diet in a group of patients with RA living in the Mediterranean basin, and, thus, in improving parameters related to subjective and objective disease markers, including plasma adiponectin concentrations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

January 1, 2014

Last Update Submit

January 4, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisMediterranean dietLifestyle interventionAdiponectinTelephone counseling

Outcome Measures

Primary Outcomes (16)

  • Change from baseline Mediterranean Diet Score at 6 months

    6 months

  • Change from baseline Disease Activity Score (DAS28) at 6 months

    6 months

  • Change from baseline Health Assessment Questionnaire (HAQ) Score at 6 months

    6 months

  • Change from baseline Short Form-36 Health Survey (SF-36) score at 6 months

    6 months

  • Change from baseline energy intake at 6 months

    6 months

  • Change from baseline in macronutrients intake at 6 months

    6 months

  • Age

    baseline

  • Height

    baseline

  • Change from baseline body weight at 6 months

    6 months

  • Change from baseline systolic blood pressure at 6 months

    6 months

  • Change from baseline plasma adiponectin concentrations at 6 months

    6 months

  • Change from baseline plasma glucose levels at 6 months

    6 months

  • Change from baseline serum triglycerides levels at 6 months

    6 months

  • Change from baseline plasma HDL-cholesterol levels at 6 months

    6 months

  • Years of education

    baseline

  • Change from baseline diastolic blood pressure at 6 months

    6 months

Study Arms (3)

Face-to-face

EXPERIMENTAL

Patients received face-to-face nutrition counseling.

Behavioral: Nutrition counseling

Telephone

EXPERIMENTAL

Patients received telephone nutrition counseling.

Behavioral: Nutrition counseling

Minimum Intervention

NO INTERVENTION

Patients in this group received no further lifestyle-related counseling and contact until the 6-month evaluation.

Interventions

Nutrition counselingBEHAVIORAL

Patients received nutrition counseling, through one-to-one sessions conducted once a month, until the 6-month evaluation. Nutrition counseling was based on goal-setting and aimed at increasing adherence to Mediterannean diet.

Face-to-faceTelephone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • rheumatoid arthritis diagnosis according to the 1987 criteria of the American College of Rheumatology
  • clinically non active disease, as assessed and documented by the patient's own rheumatology specialist

You may not qualify if:

  • being on a slimming or any other special diet during the previous year, or being diagnosed with other serious medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Euroclinic Private Hopsital

Athens, 11521, Greece

Location

Laiko General Hospital

Athens, 15773, Greece

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mary Yannakoulia, PhD

    Harokopio University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Mary Yannakoulia

Study Record Dates

First Submitted

January 1, 2014

First Posted

January 7, 2014

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

GR(2)