Evaluation of Consultation Including Genetic Aspects of Obesity

September 27, 2017 updated by: Winfried Rief, Philipps University Marburg Medical Center

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.

Study Overview

Status

Completed

Conditions

Obesity

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

420

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

BMI > 30

Exclusion Criteria:

Brain damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feeling guilty for being overweight
Negative affectivity
Self-control

Secondary Outcome Measures

Outcome Measure
weight
body acceptance
restraint eating
qualityof life
coping

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Investigators

Principal Investigator: Winfried Rief, PhD, Philipps University of Marburg, Marburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Philipps University of Marburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

October 17, 2006

First Submitted That Met QC Criteria

October 17, 2006

First Posted (Estimate)

October 18, 2006

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

WR001
01GP0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.