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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04883268
Other study ID # ERCPN-167_03_05_2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date February 2020

Study information

Verified date May 2021
Source Maastricht University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date February 2020
Est. primary completion date February 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Expand 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.

Locations

Country Name City State
Netherlands Nederlandse Obesitas Kliniek Huis ter heide Utrecht
Netherlands Maastricht University Maastricht Limburg

Sponsors (3)

Lead Sponsor Collaborator
Maastricht University Dutch Research Council, Nederlandse Obesitas Kliniek

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Primary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Primary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Primary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Primary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Secondary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
Secondary 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. Pretest (Day 1), posttest (Day 5), 1-week follow-up (Day 12), 3-month follow-up (Day 95)
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