- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04883268
Focusing on Body Functionality After Bariatric Surgery
May 6, 2021 updated by: Jessica Alleva, Maastricht University
Does Focusing on Body Functionality Improve Body Image Among Women Who Have Undergone Bariatric Surgery?
This study investigated whether focusing on one's body functionality (i.e., everything the body can do, rather than how it looks) would lead to improvements in body image, self-esteem, and self-kindness among women who have undergone bariatric surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
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Maastricht, Limburg, Netherlands, 6200MD
- Maastricht University
-
-
Utrecht
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Huis ter heide, Utrecht, Netherlands, 3712BA
- Nederlandse Obesitas Kliniek
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Identifying as female, being between 18 and 65 years old, having undergone bariatric surgery 5-7 months prior to the study, and qualifying for standard aftercare at the Nederlandse Obesitas Kliniek (NOK; Dutch Obesity Clinic).
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in the intervention group completed the Expand Your Horizon programme (Alleva et al., 2015).
|
Expand Your Horizon is an online programme, comprising three 15min writing exercises delivered over the course of 1 week.
In each writing exercise, participants are asked to describe the functions of their body, and why those are personally meaningful to them.
|
|
No Intervention: Comparison Group
Participants in the comparison group did not complete any intervention (i.e., this was a waitlist comparison group).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in appearance satisfaction over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Appearance satisfaction was assessed using the Body Areas Satisfaction Subscale (BASS) of the Multidimensional Body-Self Relations Questionnaire (MBSRQ).
Scores range from 1-5, with higher scores demonstrating higher appearance satisfaction.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
|
Change in functionality satisfaction over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Functionality satisfaction was assessed using the Physical Condition Subscale (PCS) of the Body Esteem Scale (BES).
Scores range from 1-5, with higher scores demonstrating higher functionality satisfaction.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
|
Change in body appreciation over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Body appreciation was assessed using the Body Appreciation Scale-2 (BAS-2).
Scores range from 1-5, with higher scores demonstrating higher body appreciation.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
|
Change in body responsiveness over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Body responsiveness was assessed using the Body Responsiveness Questionnaire (BRQ).
Scores range from 1-7, with higher scores demonstrating higher body responsiveness.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
|
Change in self-objectification over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Self-objectification was assessed using the Self-Objectification Questionnaire (SOQ).
Scores range from -25 to 25, with lower scores demonstrating higher levels of self-objectification.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in self-esteem over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Self-esteem was assessed using the Rosenberg Self-Esteem Scale (RSE).
Scores range from 10-40, with higher scores reflecting higher levels of self-esteem.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
|
Changes in self-kindness over time (pretest, posttest, follow-ups)
Time Frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Self-kindness was assessed using the Self-Kindness Subscale (SKS) of the Self-Compassion Scale (SCS).
Scores range from 1-7, with higher scores reflecting higher levels of self-kindness.
|
Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jessica Alleva, Maastricht University
- Principal Investigator: Carolien Martijn, Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
February 1, 2020
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
April 30, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ERCPN-167_03_05_2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymised quantitative data (SPSS file) will be uploaded to DataVerse, and will be accessible upon request from the Principal Investigator.
Study protocol and informed consent sheet will be available via ClinicalTrials.gov
registration.
IPD Sharing Time Frame
The data will become available as soon as the manuscript is published, with no deadline.
The study protocol and informed consent sheet will be available immediately, with no deadline.
IPD Sharing Access Criteria
Data will be available to other researchers for non-commercial purposes.
Qualitative data (derived from participants' responses to the writing exercises) will not be shared, given the sensitive nature of the data, and given that participants did not provide consent for their writing exercises to be shared outside of the research team.
Study protocol and informed consent sheet will be available for non-commercial purposes via ClinicalTrials.gov
registration.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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