Focusing on Body Functionality After Bariatric Surgery

NCT04883268 | Completed DMC

• 1 other identifier: ERCPN-167_03_05_2016
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bariatric Surgery Candidate; Body Image

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Changes in self-esteem over time (pretest, posttest, follow-ups)

  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)

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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).

Interventions

Expand Your Horizon OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• N/A

Sponsors & Collaborators

• Maastricht University: lead
• Nederlandse Obesitas Kliniek: collaborator
• Dutch Research Council: collaborator

Study Sites (2)

Maastricht University

Maastricht, Limburg, 6200MD, Netherlands

Location

Nederlandse Obesitas Kliniek

Huis ter Heide, Utrecht, 3712BA, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 26280376 BACKGROUND

• Alleva 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.

  PMID: 36608971 DERIVED

Study Officials

• Jessica Alleva

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Carolien Martijn

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants are randomised to group by the online research system. The investigator does not know what group participants have been assigned to. Participants are aware whether they have been assigned to the intervention or comparison (waitlist) group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 12, 2021
• Study Start: September 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

NL (2)