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The predictive value of the self-regulation capacity for the compliance with postoperative behavioral prescriptions after bariatric surgery in morbid obesity: predictor for success?


- candidate number4110
- NTR NumberNTR1455
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2008
- Secondary IDs08-T-63 (METC) Atrium Medical Center, Heerlen
- Public TitleThe predictive value of the self-regulation capacity for the compliance with postoperative behavioral prescriptions after bariatric surgery in morbid obesity: predictor for success?
- Scientific TitleThe predictive value of the self-regulation capacity for the compliance with postoperative behavioral prescriptions after bariatric surgery in morbid obesity: predictor for success?
- ACRONYMSelf-regulation capacity: predictor for success after bariatric surgery?
- hypothesisSelf-regulation capacity is a predictor of compliance after bariatric surgery. Self-regulation capacity is a predictor of success after bariatric surgery (weight loss, quality of life, satisfaction). Compliance is a predictor of success (weight loss, quality of life, satisfaction). Compliance is a mediator between self-regulation capacity and success.
- Healt Condition(s) or Problem(s) studiedQuality of life, Psychosocial, Morbid obesity , Compliance, Bariatric surgery
- Inclusion criteria1. Every adult patient (minimal age of 18 years) in Atrium MC who will be admitted to a bariatric surgery procedure in pursuance of the clinical selection procedure and has given permission for participating in the study after informed consent
- Exclusion criteria1. Not be master of the Dutch language
2. Mentally deficient
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-nov-2016
- Target number of participants109
- InterventionsNo interventions are object of the study.
The study is an obervational study, using self-report questionnaires.
- Primary outcome- Weight loss (measured bij a M.D.)
- Quality of life (questionnaire)
- Satisfaction with the result of the treatment (bariatric surgery)(questionnaire)
- Compliance (questionnaire)
- Secondary outcomeNone
- Timepoints- pretest (1-3 months before surgery)
- postoperative: 3-6-12-18-24 months
- after that every year for the next three years
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. S. Salet
- CONTACT for SCIENTIFIC QUERIESDrs. S. Salet
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsN/A
- Brief summaryBariatric surgery, a collective noun for different procedures of surgical gastric reduction, is an affective treatment for patients with morbid obesity (Body Mass Index >= 40). In approximately 20-30% of the cases, however, an insufficient result (in terms of especially weight loss) is gained. For the treatment to be affective, the patients have to make adjustments in their way of living (eating and exercising) after the surgery. Many studies have tried to find psychological predictors of success. The results, however, are ambiguous, non consistent or even contradictory. The self-regulation capacity as a possible predictor has scarcely been investigated. Besides, most studies are not concerned with the measure of compliance with postoperative behavioral prescriptions. The hypotheses are that the self-regulation capacity is a predictor of success and that the measure of compliance with postoperative behavioral prescriptions is a mediator between the self-regulation capacity and success in terms of weight loss, quality of life and satisfaction with the result of the treatment. The study is an observational study.
- Main changes (audit trail)
- RECORD24-sep-2008 - 1-okt-2008


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