Cue Exposure Training for Overweight Children

October 13, 2015 updated by: Maastricht University Medical Center
The primary objective of the study is to investigate the effectiveness of two intensive two-session trainings, the conventional psycho-education and food cue exposure, on eating in the absence of hunger, binge eating and Body Mass Index (BMI) change in overweight/ obese children.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Centre (MUMC+)

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

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being a patient in the Maastricht University Medical Center COACH unit for obese children and adolescents.
  • Overweight, according to the sex and age specific cut-off point for overweight in children, as defined by Cole and colleagues (2000).
  • Age: 12 - 18 years

Exclusion Criteria:

  • Not being overweight (anymore, due to weight loss)
  • Not able to speak and/or write Dutch

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Food cue exposure
Behavioral: Food cue exposure
Participants will be exposed to several kinds of their favorite food. The aim of this exposure is to increase the food cravings as much as possible.
ACTIVE_COMPARATOR: Psycho-education
Behavioral: Psycho-education
General information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating in the absence of hunger
Time Frame: 2 - 3 months
Self-reported & behaviourally measured eating in the absence of hunger
2 - 3 months
Binge eating
Time Frame: 2 - 3 months
Self-reported binge eating
2 - 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cue reactivity
Time Frame: 2 - 3 months
Reactivity to food related cues, measured by food cravings and salivary responses
2 - 3 months
Self-control and self-esteem
Time Frame: 2 - 3 months
Self-reported self-control and self-esteem
2 - 3 months
Dietary restraint, and eating, weight and shape concerns
Time Frame: 2 - 3 months
Self-reported dietary restraint, and eating, weight and shape concerns
2 - 3 months
BMI change
Time Frame: 2 - 3 months
Body Mass Index change
2 - 3 months

Other Outcome Measures

Outcome Measure
Time Frame
Self-reported expectation and evaluation of intervention
Time Frame: 2 - 3 months
2 - 3 months

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Collaborators

Maastricht University
Netherlands Organisation for Scientific Research

Investigators

  • Principal Investigator: Anita Jansen, Professor, Maastricht University

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.

General Publications

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

January 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (ESTIMATE)

February 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 13-2-009
  • NWO (OTHER_GRANT: Vici grant 453.10.006, awarded to Anita Jansen)

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.

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