CClinicalTrials.gg
CompletedNCT04883268Updated May 12, 2021

Focusing on Body Functionality After Bariatric Surgery

An interventional study of Expand Your Horizon in Bariatric Surgery Candidate and Body Image, sponsored by Maastricht University. Completed at 2 sites in Netherlands. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-12.

Sponsored by Maastricht University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 7 months after the study started (first participant enrolled Sep 2016, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
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Study 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.

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Conditions studied

  • Bariatric Surgery Candidate
  • Body Image
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In context

Lead sponsor

Maastricht University is the lead sponsor of 96 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • N/A
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Participants in the intervention group completed the Expand Your Horizon programme (Alleva et al., 2015).

    Other: Expand Your Horizon

  • No intervention
    Comparison Group

    Participants in the comparison group did not complete any intervention (i.e., this was a waitlist comparison group).

Interventions

  • OtherExpand Your Horizon

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

  2. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

  3. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

  4. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

  5. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

Secondary outcomes

  1. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

  2. 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.

    Time frame: Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)

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Study locations

2 sites
  • Maastricht University
    Maastricht, Limburg 6200MD, Netherlands
  • Nederlandse Obesitas Kliniek
    Huis ter heide, Utrecht 3712BA, Netherlands
08

References and documents

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 26280376 ↗

Study documents

  • Study protocol · Jun 2, 2016
  • Informed consent form · Jun 2, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04883268
Lead sponsor
Maastricht University
Collaborators
Nederlandse Obesitas Kliniek, Dutch Research Council
Responsible party
Jessica Alleva (Assistant Professor, Maastricht University) — Principal investigator
First posted
May 12, 2021
Start date
Sep 2016
Primary completion
Feb 2020
Completion
Feb 2020
Last update
May 12, 2021

Study contacts

Jessica Alleva
principal investigator · Maastricht University
Carolien Martijn
principal investigator · Maastricht University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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