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OpenTrials
Completed

NCT Number: NCT00389246

Evaluation of Consultation Including Genetic Aspects of Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI > 30

Exclusion criteria

  • Brain damage

Treatment and study plan

Consultation without genetic information

Behavioral

Consultation with genetic information

Behavioral

Primary outcomes

  1. Feeling guilty for being overweight

  2. Negative affectivity

  3. Self-control

Secondary outcomes

  1. weight

  2. body acceptance

  3. restraint eating

  4. qualityof life

  5. coping

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Oct 18, 2006
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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