NCT01527851

Brief Summary

Introduction: Currently, bariatric surgery appears to be the most effective treatment to improve the health of morbidly obese population. However, the massive weight loss induced by this intervention can create excess loose skin in various parts of the body contributing to the feeling of failure in their desire to feel better in some patients. Several studies show that people are once again disappointed and dissatisfied with their body appearance due to the mass of unsightly loose skin that disrupts their quality of life. However, very few studies have focused on the barriers that this excess skin could create in everyday physical activity. The aim of the investigators pilot study is to assess the impact of excess skin on the practice of physical activity in women who underwent bariatric surgery and evaluate if there is a relationship between physical activity and the level and location of excess skin. Also, the investigators will explore, the benefits of plastic surgery in patients who had this intervention. Materials and methods: About twenty women who underwent bariatric surgery and a dozen who had subsequent plastic surgery will be included in this pilot study. Anthropometry, weight loss post bariatric and plastic surgery, motivational stage on the practice of physical activity, usual practice of physical activity, functional and physical ability, perceived benefits and barriers of physical activity, self-esteem and quality of life will be assessed. After analyzing the results, a group discussion will be established to further evaluate the impact of excess skin on the practice of physical activity. The evaluation will be identical for monitoring the effects of plastic surgery but the discussion group will also address the benefits and satisfaction related to plastic surgery. Expected results: Excess skin could be a barrier to physical activity by limiting the functional and physical capacity. Thus, plastic surgery could improve the practice of physical activity with a direct improvement of functional discomfort, the subjects' motivation to be physically active, perceived benefits and barriers to physical activity, self-esteem and quality of life. Issue project: This pilot project will generate data that will allow us, depending on the relevance of the results, to continue the investigators investigation with a larger cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2014

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

February 1, 2012

Last Update Submit

January 12, 2021

Conditions

Keywords

Post-bariatric surgeryExcess skinPhysical fitnessPhysical activityBarriers to physical activityPlastic surgeryQuality of lifeSelf-esteem

Outcome Measures

Primary Outcomes (1)

  • Physical activity pratice

    Inconvenience during physical activity

    Initial

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A group of 20 people who underwent bariatric surgery and a group of 10 people who underwent bariatric surgery and one or several plastic surgery

You may qualify if:

  • have underwent bariatric surgery more than 1 year ago
  • had a weight loss of at least 20% after bariatric surgery
  • had a weight change of less than 5 kg in the last 3 months
  • woman \> 18 years old
  • have read and given consent
  • have underwent a plastic surgery at least 6 months ago

You may not qualify if:

  • medical contraindication for physical activity
  • major functional limitations : failure to realize different tests
  • intellectual disability and/or neuropsychological disease
  • not being able to speak or understand french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

  • Baillot A, Asselin M, Comeau E, Meziat-Burdin A, Langlois MF. Impact of excess skin from massive weight loss on the practice of physical activity in women. Obes Surg. 2013 Nov;23(11):1826-34. doi: 10.1007/s11695-013-0932-0.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 7, 2012

Study Start

February 1, 2012

Primary Completion

October 21, 2014

Study Completion

January 11, 2021

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations