Evaluation of Consultation Including Genetic Aspects of Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Consultation without genetic information

Intervention Type BEHAVIORAL

Consultation with genetic information

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI \> 30

Exclusion Criteria

* Brain damage

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Winfried Rief

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Winfried Rief, PhD

Role: PRINCIPAL_INVESTIGATOR

Philipps University of Marburg, Marburg, Germany

Other Identifiers

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01GP0209

Identifier Type: -

Identifier Source: secondary_id

WR001