Evaluation of Consultation Including Genetic Aspects of Obesity - Full Text View

Sponsored by:	Philipps University Marburg Medical Center
Information provided by:	Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:	NCT00389246

Purpose

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.

Condition	Intervention	Phase
Obesity	Behavioral: Consultation without genetic information Behavioral: Consultation with genetic information	Phase III

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Consultation Including Genetic Aspects of Obesity

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:

Feeling guilty for being overweight
Negative affectivity
Self-control

Secondary Outcome Measures:

weight
body acceptance
restraint eating
qualityof life
coping

Estimated Enrollment:	420
Study Start Date:	September 2002
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI > 30

Exclusion Criteria:

Brain damage

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389246

Sponsors and Collaborators

Philipps University Marburg Medical Center

Investigators

Principal Investigator:

Winfried Rief, PhD

Philipps University of Marburg, Marburg, Germany

More Information

Philipps University of Marburg, Germany This link exits the ClinicalTrials.gov site

Study ID Numbers:	WR001, 01GP0209
Study First Received:	October 17, 2006
Last Updated:	October 17, 2006
ClinicalTrials.gov Identifier:	NCT00389246
Health Authority:	Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:

obesity
genetic consultation
randomized controlled trial

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009