1) To investigate the impact of keeping/loosing diabetes on quality of life and psychological well-being in a group of (morbidly) obese patients who underwent bariatric surgery, and 2) To explore whether we can predict postoperative quality of life…
ID
Source
Brief title
Condition
- Other condition
- Diabetic complications
- Mood disorders and disturbances NEC
Synonym
Health condition
(morbide) obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Interviews assessing diabetes-related psychological well-being and
diabetes-related quality of life after surgery, to (former) diabetes patients.
- Symptom Checking List (SCL-90), before and after surgery
- Quality of life (RAND-36), before and after surgery
Secondary outcome
- Problem Areas In Diabetes (PAID). This questionnaire will be completed in the
presurgical course. The outcome will also be used as a qualitative guide for
the postsurgical interview.
- Dutch Personality Questionnaire (NPV), before surgery: to see which
personality characteristics can predict postoperative well-being and quality of
life in diabetes patients.
- weight reduction (BMI).
Background summary
Morbid obesity with its related comorbidities is an increasing problem in
Western societies. Bariatric surgery proved to be an effective intervention to
accomplish substantial weight loss. As a result, patients generally show
improvements in quality of life, in emotional well-being and in medical
comorbidities like diabetes mellitus type 2 (DM2). DM2 is a burdensome, chronic
disease that demands daily selfcare and is associated with substantially
increased risk for cardiovascular diseases, depression and anxiety disorders.
Up to 83% of the patients do not meet the criteria for DM2 anymore within weeks
after bariatric surgery. It is currently unknown to which extent psychological
factors (such as personality characteristics) in the preoperative course
predict diabetes-related quality of life and emotional well-being in the
post-operative course. It is also unclear how patients perceive the impact of
keeping/loosing diabetes. It might be plausible that patients with preoperative
existing diabetes will experience less improvement in psychological well-being
and quality of life, given the burdensome nature of DM2. Though, it might be
possible that patients experience an extra relief when *cured* from a chronic
condition.
Study objective
1) To investigate the impact of keeping/loosing diabetes on quality of life and
psychological well-being in a group of (morbidly) obese patients who underwent
bariatric surgery, and 2) To explore whether we can predict postoperative
quality of life (QoL) in these diabetes patients using baseline patient
characteristics (demographic data, baseline emotional well-being and
personality characteristics).
Study design
We will conduct an observational, prospective research. Participants will be
included before bariatric surgery and will be invited to complete a second set
of questionnaires a minimum of three months after surgery. It is known that
beneficial effects of bariatric surgery on DM2 occur within a few weeks.
Participants who had (or still have) DM2 but are then *cured* after the
surgery, take part in an interview about the psychological sequelae of their
(former) DM2. Diagnostics regarding the DM2 is part of a standard procedure in
the bariatric treatment and is not an extra measurement for the benefit of this
research. This is also the case for the weight-loss measurements. The study
will be starting at the 15th of December 2011 and ends at the 1st of March
2014. Participants who will undergo a bariatric procedure will be recruited at
the Máxima Medical Centre.
Study burden and risks
Time-investment for the participant:
- Obese patients without DM2: 30 minutes presurgically (questionnaires:
RAND-36, NPV), and 20 minutes postsurgically (questionnaires: RAND-36, SCL-90).
These questionnaires can be completed by the participant at home.
- Obese patients with DM2: 35 minutes presurgically (questionnaires: RAND-36,
NPV, PAID) and 80 minutes postsurgically (questionnaires: RAND-36, SCL-90 and
interview).
The completion of the SCL-90 in the presurgical course is a standard procedure
for every patient who will undergo bariatric surgery.
The questionnaires can be completed at home by the participant, the interview
will be held at the department of Medical Psychology of the Máxima Medical
Centre Eindhoven.
Risks:
There are no risks, although people can be confronted with the psychological
impact of their disease during the completion of the questionnaires and during
the interview. In clinical practise, this is seldom the case. If people have
problems coping this themselves, they can contact the researcher, D. Tak,
post-graduate health care psychologist (registered).
Ds. Th. Fliednerstraat 1
5631 BM Eindhoven
NL
Ds. Th. Fliednerstraat 1
5631 BM Eindhoven
NL
Listed location countries
Age
Inclusion criteria
- Body Mass Index (BMI) ><= 35, with and without diabetes mellitus type 2
- patients are screened by a surgeon, physiotherapist, dietician and psychologist for eligibility of surgery: the patient bariatric is already medically and psychologically approved for bariatric surgery.
Exclusion criteria
- psychiatric disorder(s) and eating disorders: all patients have already been examined by a health psychologist. Tools: clinical interview and questionnaires.
- present use of antidepressant and/or anxiety medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37873.015.11 |