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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01796340
Other study ID # METC 13-2-009
Secondary ID NWO
Status Terminated
Phase N/A
First received February 20, 2013
Last updated October 13, 2015
Start date January 2014
Est. completion date October 2014

Study information

Verified date October 2014
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Netherlands Maastricht University Medical Centre (MUMC+) Maastricht Limburg

Sponsors (3)

Lead Sponsor Collaborator
Maastricht University Medical Center Maastricht University, Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Jansen A. A learning model of binge eating: cue reactivity and cue exposure. Behav Res Ther. 1998 Mar;36(3):257-72. Review. — View Citation

Martinez-Mallén E, Castro-Fornieles J, Lázaro 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Self-reported expectation and evaluation of intervention 2 - 3 months No
Primary Eating in the absence of hunger Self-reported & behaviourally measured eating in the absence of hunger 2 - 3 months No
Primary Binge eating Self-reported binge eating 2 - 3 months No
Secondary Cue reactivity Reactivity to food related cues, measured by food cravings and salivary responses 2 - 3 months No
Secondary Self-control and self-esteem Self-reported self-control and self-esteem 2 - 3 months No
Secondary Dietary restraint, and eating, weight and shape concerns Self-reported dietary restraint, and eating, weight and shape concerns 2 - 3 months No
Secondary BMI change Body Mass Index change 2 - 3 months No
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