Evaluation of Consultation Including Genetic Aspects of Obesity

Study Overview
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Brief Summary
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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. 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.

Detailed Description
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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.

Official Title
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Evaluation of Consultation Including Genetic Aspects of Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Consultation without genetic information
* Behavioral: Consultation with genetic information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 30 Exclusion Criteria: Brain damage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Consultation without genetic information|nan|
|Behavioral: Consultation with genetic information|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeling guilty for being overweight |  |  | 
| Negative affectivity |  |  | 
| Self-control |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  |  | 
| body acceptance |  |  | 
| restraint eating |  |  | 
| qualityof life |  |  | 
| coping |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, genetic consultation, randomized controlled trial