Evaluation of Consultation Including Genetic Aspects of Obesity
|Obesity||Behavioral: Consultation without genetic information Behavioral: Consultation with genetic information||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Consultation Including Genetic Aspects of Obesity|
- Feeling guilty for being overweight
- Negative affectivity
- body acceptance
- restraint eating
- qualityof life
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||June 2005|
More than 1,000 obese people are screened for genetic mutations (MC4R). Those with positive screenings as well as 320 randomly selected people without MC4R mutations are randomized to 2 consultation types: one including recommendations for eating and physical activity behavior, the other with an additional part on genetic determinants and actions in obesity. Their results are compared to a control group (n>100). It is hypothesized that obese people with obesity-specific genetic mutations, and obese people with a family history of obesity, benefit more if the consultation includes additional elements on genetic determinants.
The following variables are used: BMI, SCID interview for mental disorders, Stunkard's body silhouttes for participants and their parents and siblings, Restraint Eating Scale, PANAS, Well-being scale, body acceptance, shame and guilt, coping with obesity, participant's satisfaction with consultation.
Assessment Points: before consultation, after consultation, 6 months later.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389246
|Principal Investigator:||Winfried Rief, PhD||Philipps University of Marburg, Marburg, Germany|