Towards a more custom tailored treatment of obesity: Subtyping the motivation to overeat.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR3267
• Date of registration: 31/01/2012
• Primary sponsor: Alan Turing Institute Almere
• Public title: Towards a more custom tailored treatment of obesity: Subtyping the motivation to overeat.
• Scientific title: Towards a more custom tailored treatment of obesity: Subtyping the motivation to overeat. -
• Date of first enrolment: 1/3/2012
• Target sample size: 400
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3267
• Study type: observational
• Study design: Randomised: No; Masking: [default]; Control: Not applicable; Group: Parallel; Type: Single arm

Countries of recruitment

The Netherlands

Contacts

• Name: A. Alkemade

• Name: A. Alkemade

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects must be between 18≤ age ≤70 years;

2. BMI≥35;

3. Subjects must be able to read and understand Dutch language and instructions;

4. Subjects must have ample sight and hearing, or corrected sight and hearing to a level that this does not interfere with the neuropsychological testing;

5. Signed informed consent.
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study:

1. Pregnancy;

2. Use of psychoactive medication (ATC groups N03 through N07), or medication with significant psychoactive side-effects, currently or during the past 3 months, including, but not restricted to antidepressants, psychostimulants and antipsychotics;

3. Use of medication with significant effects on body weight, currently or during the past 3 months, with the exception of drugs used for treatment of comorbidities of obesity, such as for type 2 diabetes, in case of the use of metformin, sulfonylureum derivatives, thiazolidinediones, DPP4 inhibitors, GLP1 analogues, or meglitinides);

4. Significant use of illicit psychoactive substances, currently or during the past 3 months as reported by the participant;

5. Abuse of or dependence on legal psychoactive substances (alcohol, nicotine, cannabis), currently or during the past 3 months. Smoking is associated with altered performance on two subscales of the BIS BAS questionnaire (Voigt et al, 2009). In addition, smoking has clear effects on energy expenditure. This is expected to generalize to other substances and neuropsychological tests;

6. Use of any psychoactive substance (excluding nicotine and caffeine) on the testing day;

7. A significant change (quitting attempt or starting) in the use of legal psychoactive drugs in the past three months;

8. Known underlying clinically relevant endocrine disease, or mobility impairments underlying the development of obesity, e.g.

A. Thyroid disease;

B. Cushing?s disease;

C. Parkinson?s disease;

D. Being bound to a wheelchair (with the exception of being bound to a wheelchair as a result of obesity).

9. Color blindness, since this interferes with the interpretation of the instructions and stimuli for the neuropsychological tasks;

10. Inability to comprehend the questionnaires or follow the instructions sufficiently in the opinion of the supervising doctor or investigator (at any time during the test visit).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

N/A

Primary Outcome(s)

The classification of the obese into three personality subtypes, assessment of the motivational behavior and the role of genetic and biochemical variations. The design of the study is cross-sectional and aimed to clarify which parameters and interactions are most important in obesity. Causal relationships of the most important parameters will need to be investigated in future studies.

Secondary Outcome(s)

Refinement of the above classification.

The distribution of comorbidities among the above subtypes.

Secondary ID(s)

NL28955.044.11 / P12-02;

Source(s) of Monetary Support

Alan Turing Institute Almere