Bariatric Surgery CandidateNCT04883268
Focusing on Body Functionality After Bariatric Surgery
A study testing Expand Your Horizon in people with Bariatric Surgery Candidate and Body Image, run by Maastricht University at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate, Body Image
- What is being tested?
- Expand Your Horizon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Nederlandse Obesitas Kliniek
Huis ter Heide, Utrecht, 3712BA
Maastricht University
Maastricht, Limburg, 6200MD
About this study
Official title: 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.
- Conditions
- Bariatric Surgery Candidate, Body Image
- Being tested
- Expand Your Horizon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expand Your HorizonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group completed the Expand Your Horizon programme (Alleva et al., 2015). Receives: Other: Expand Your Horizon |
| Comparison Group | No intervention | Participants in the comparison group did not complete any intervention (i.e., this was a waitlist comparison group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in appearance satisfaction over time (pretest, posttest, follow-ups)
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.
Measured: 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)
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.
Measured: 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)
Body appreciation was assessed using the Body Appreciation Scale-2 (BAS-2). Scores range from 1-5, with higher scores demonstrating higher body appreciation.
Measured: 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)
Body responsiveness was assessed using the Body Responsiveness Questionnaire (BRQ). Scores range from 1-7, with higher scores demonstrating higher body responsiveness.
Measured: 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)
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.
Measured: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Secondary outcomes (2)
Changes in self-esteem over time (pretest, posttest, follow-ups)
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.
Measured: 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)
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.
Measured: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study startSep 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Nederlandse Obesitas Kliniek, Dutch Research Council
- Responsible party
- Principal investigator, Jessica Alleva, Maastricht University
- Investigators
- Jessica Alleva, Principal investigator, Maastricht UniversityCarolien Martijn, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883268
- Sponsor's protocol ID
- ERCPN-167_03_05_2016
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Alleva JM, Martijn C, Van Breukelen GJ, Jansen A, Karos K. Expand Your Horizon: A programme that improves body image and reduces self-objectification by training women to focus on body functionality. Body Image. 2015 Sep;15:81-9. doi: 10.1016/j.bodyim.2015.07.001. Epub 2015 Aug 14.
PubMed 26280376Alleva JM, Atkinson MJ, Vermeulen W, Monpellier VM, Martijn C. Beyond Body Size: Focusing on Body Functionality to Improve Body Image Among Women Who Have Undergone Bariatric Surgery. Behav Ther. 2023 Jan;54(1):14-28. doi: 10.1016/j.beth.2022.06.007. Epub 2022 Jul 3.
PubMed 36608971
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Focusing on Body Functionality Improve Body Image Among Women Who Have Undergone Bariatric Surgery?
- ClinicalTrials.gov ID
- NCT04883268
- Acronym / sponsor ID
- ERCPN-167_03_05_2016
- Conditions
- Bariatric Surgery Candidate, Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Nederlandse Obesitas Kliniek, Dutch Research Council
- Study start
- Sep 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Expand Your HorizonParticipants in the intervention group completed the Expand Your Horizon programme (Alleva et al., 2015). |
| Comparison Group | No intervention | –Participants in the comparison group did not complete any intervention (i.e., this was a waitlist comparison group). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expand Your HorizonExpand 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. | Other | Intervention Group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 26280376Alleva JM, Martijn C, Van Breukelen GJ, Jansen A, Karos K. Expand Your Horizon: A programme that improves body image and reduces self-objectification by training women to focus on body functionality. Body Image. 2015 Sep;15:81-9. doi: 10.1016/j.bodyim.2015.07.001. Epub 2015 Aug 14.
- Derived from this study: PubMed 36608971Alleva JM, Atkinson MJ, Vermeulen W, Monpellier VM, Martijn C. Beyond Body Size: Focusing on Body Functionality to Improve Body Image Among Women Who Have Undergone Bariatric Surgery. Behav Ther. 2023 Jan;54(1):14-28. doi: 10.1016/j.beth.2022.06.007. Epub 2022 Jul 3.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Alleva principal investigator
Maastricht University
Carolien Martijn principal investigator
Maastricht University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expand Your Horizon in people with Bariatric Surgery Candidate and Body Image, run by Maastricht University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021; AzTrials last refreshed its copy on 29 Oct 2026.