Clinical Trials Directory

Trials / Completed

CompletedNCT00389246

Evaluation of Consultation Including Genetic Aspects of Obesity

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
420 (planned)
Sponsor
Philipps University Marburg · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALConsultation without genetic information
BEHAVIORALConsultation with genetic information

Timeline

Start date
2002-09-01
Completion
2005-06-01
First posted
2006-10-18
Last updated
2017-10-02

Source: ClinicalTrials.gov record NCT00389246. Inclusion in this directory is not an endorsement.