NCT00389246

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Sep 2002

Typical duration for phase_3 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

First QC Date

October 17, 2006

Last Update Submit

September 27, 2017

Conditions

Obesity

Keywords

obesitygenetic consultationrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Feeling guilty for being overweight

  • Negative affectivity

  • Self-control

Secondary Outcomes (5)

  • weight

  • body acceptance

  • restraint eating

  • qualityof life

  • coping

Interventions

Consultation without genetic informationBEHAVIORAL
Consultation with genetic informationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 30

You may not qualify if:

  • Brain damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Winfried Rief, PhD

    Philipps University of Marburg, Marburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

September 1, 2002

Study Completion

June 1, 2005

Last Updated

October 2, 2017

Record last verified: 2017-09