NCT02532751

Brief Summary

The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

August 17, 2015

Last Update Submit

February 21, 2018

Conditions

Validation StudyQuality of Life

Outcome Measures

Primary Outcomes (4)

  • Validity of the Finnish version of the BODY-Q questionnaire

    The psychometric properties of the BODY-Q patient-reported outcome measure are measured

    6 months

  • Health-related quality of life after body contouring surgery in obese patients

    Health-related quality of life is assessed with a questionnaire

    0.5 to 3 years

  • Depression after body contouring surgery in obese patients

    Depression is assessed with a questionnaire

    0.5 to 3 years

  • Body image after body contouring surgery in obese patients

    Body image is assessed with a questionnaire

    0.5 to 3 years

Secondary Outcomes (3)

  • The 15-Dimensions health-related quality of life instrument

    0.5 to 3 years

  • The BODY-Q questionnaire

    0.5 to 3 years

  • The Raitasalo Beck Depression Index questionnaire

    0.5 to 3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 patients who underwent body contour surgery

You may qualify if:

  • Body contouring surgery due to:
  • A) massive weight loss B) Postbariatric weight loss
  • Patient age over 18 years

You may not qualify if:

  • Patient age under 18 years
  • No body contouring surgery
  • Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District
  • No obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jorvi Central Hospital

Espoo, Uusimaa, Finland

Location

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Central Study Contacts

Jussi P Repo, MD

CONTACT

+358443593100mrjussirepo@gmail.com

Pentscho Popov, MD, PhD

CONTACT

+35894711pentscho.popov@hus.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 26, 2015

Study Start

April 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

FI(2)