NCT01796340

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 20, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

February 20, 2013

Last Update Submit

October 13, 2015

Conditions

OverweightObesity

Keywords

cue exposurechildhoodovereatingoverweightobesetreatment

Outcome Measures

Primary Outcomes (2)

  • Eating in the absence of hunger

    Self-reported \& behaviourally measured eating in the absence of hunger

    2 - 3 months

  • Binge eating

    Self-reported binge eating

    2 - 3 months

Secondary Outcomes (4)

  • Cue reactivity

    2 - 3 months

  • Self-control and self-esteem

    2 - 3 months

  • Dietary restraint, and eating, weight and shape concerns

    2 - 3 months

  • BMI change

    2 - 3 months

Other Outcomes (1)

  • Self-reported expectation and evaluation of intervention

    2 - 3 months

Study Arms (2)

Food cue exposure

EXPERIMENTAL
Behavioral: Food cue exposure

Psycho-education

ACTIVE COMPARATOR
Behavioral: Psycho-education

Interventions

Food cue exposureBEHAVIORAL

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.

Food cue exposure
Psycho-educationBEHAVIORAL

General information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed.

Psycho-education

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre (MUMC+)

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 2576871BACKGROUND

  • 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.

    PMID: 1586360BACKGROUND

  • 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.

    PMID: 9642846BACKGROUND

  • 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.

    PMID: 12898559BACKGROUND

  • 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.

    PMID: 17607695BACKGROUND

  • 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.

    PMID: 22122291BACKGROUND

MeSH Terms

Conditions

OverweightObesityHyperphagia

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Anita Jansen, Professor

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 21, 2013

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 15, 2015

Record last verified: 2014-10

Locations

NL(1)