Evaluation of Consultation Including Genetic Aspects of Obesity

This study has been completed.
Sponsor:
Information provided by:
Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT00389246
First received: October 17, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Consultation Including Genetic Aspects of Obesity

Resource links provided by NLM:


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
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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

Additional Information:
No publications provided

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

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014