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Evaluation of Consultation Including Genetic Aspects of Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389246
First Posted: October 18, 2006
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Winfried Rief, Philipps University Marburg Medical Center
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Consultation Including Genetic Aspects of Obesity

Further study details as provided by Winfried Rief, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > 30

Exclusion Criteria:

  • Brain damage
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389246


Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Winfried Rief, PhD Philipps University of Marburg, Marburg, Germany
  More Information

Additional Information:
Responsible Party: Winfried Rief, Professor Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00389246     History of Changes
Other Study ID Numbers: WR001
01GP0209
First Submitted: October 17, 2006
First Posted: October 18, 2006
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Winfried Rief, Philipps University Marburg Medical Center:
obesity
genetic consultation
randomized controlled trial

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms