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Cue Exposure Training for Overweight Children

Primary Purpose

Overweight, Obesity

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Food cue exposure
Psycho-education
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring cue exposure, childhood, overeating, overweight, obese, treatment

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Centre (MUMC+)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Food cue exposure

Psycho-education

Arm Description

Outcomes

Primary Outcome Measures

Eating in the absence of hunger
Self-reported & behaviourally measured eating in the absence of hunger
Binge eating
Self-reported binge eating

Secondary Outcome Measures

Cue reactivity
Reactivity to food related cues, measured by food cravings and salivary responses
Self-control and self-esteem
Self-reported self-control and self-esteem
Dietary restraint, and eating, weight and shape concerns
Self-reported dietary restraint, and eating, weight and shape concerns
BMI change
Body Mass Index change

Full Information

First Posted
February 20, 2013
Last Updated
October 13, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Maastricht University, Netherlands Organisation for Scientific Research
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1. Study Identification

Unique Protocol Identification Number
NCT01796340
Brief Title
Cue Exposure Training for Overweight Children
Official Title
Cue Exposure Training for Overweight Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient number of participants
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Maastricht University, Netherlands Organisation for Scientific Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
cue exposure, childhood, overeating, overweight, obese, treatment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Food cue exposure
Arm Type
Experimental
Arm Title
Psycho-education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Food cue exposure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education
Intervention Description
General information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed.
Primary Outcome Measure Information:
Title
Eating in the absence of hunger
Description
Self-reported & behaviourally measured eating in the absence of hunger
Time Frame
2 - 3 months
Title
Binge eating
Description
Self-reported binge eating
Time Frame
2 - 3 months
Secondary Outcome Measure Information:
Title
Cue reactivity
Description
Reactivity to food related cues, measured by food cravings and salivary responses
Time Frame
2 - 3 months
Title
Self-control and self-esteem
Description
Self-reported self-control and self-esteem
Time Frame
2 - 3 months
Title
Dietary restraint, and eating, weight and shape concerns
Description
Self-reported dietary restraint, and eating, weight and shape concerns
Time Frame
2 - 3 months
Title
BMI change
Description
Body Mass Index change
Time Frame
2 - 3 months
Other Pre-specified Outcome Measures:
Title
Self-reported expectation and evaluation of intervention
Time Frame
2 - 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Jansen, Professor
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre (MUMC+)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
2576871
Citation
Jansen A, Van den Hout MA, De Loof C, Zandbergen J, Griez E. A case of bulimia successfully treated by cue exposure. J Behav Ther Exp Psychiatry. 1989 Dec;20(4):327-32. doi: 10.1016/0005-7916(89)90064-5.
Results Reference
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PubMed Identifier
1586360
Citation
Jansen A, Broekmate J, Heymans M. Cue-exposure vs self-control in the treatment of binge eating: a pilot study. Behav Res Ther. 1992 May;30(3):235-41. doi: 10.1016/0005-7967(92)90069-s.
Results Reference
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PubMed Identifier
9642846
Citation
Jansen A. A learning model of binge eating: cue reactivity and cue exposure. Behav Res Ther. 1998 Mar;36(3):257-72. doi: 10.1016/s0005-7967(98)00055-2.
Results Reference
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PubMed Identifier
12898559
Citation
Toro J, Cervera M, Feliu MH, Garriga N, Jou M, Martinez E, Toro E. Cue exposure in the treatment of resistant bulimia nervosa. Int J Eat Disord. 2003 Sep;34(2):227-34. doi: 10.1002/eat.10186.
Results Reference
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PubMed Identifier
17607695
Citation
Martinez-Mallen E, Castro-Fornieles J, Lazaro L, Moreno E, Morer A, Font E, Julien J, Vila M, Toro J. Cue exposure in the treatment of resistant adolescent bulimia nervosa. Int J Eat Disord. 2007 Nov;40(7):596-601. doi: 10.1002/eat.20423.
Results Reference
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PubMed Identifier
22122291
Citation
Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
Results Reference
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Cue Exposure Training for Overweight Children

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