OverweightNCT01796340
Cue Exposure Training for Overweight Children
A study testing Food cue exposure and Psycho-education in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Food cue exposure and Psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not being overweight (anymore, due to weight loss)
- Not able to speak and/or write Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre (MUMC+)
Maastricht, Limburg, 6202 AZ
About this study
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.
- Conditions
- Overweight, Obesity
- Being tested
- Food cue exposure, Psycho-education
- Keywords
- cue exposure, childhood, overeating, overweight, obese, treatment
- Medical subject headings
- Overweight, Obesity, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food cue exposureBehavioural
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-educationBehavioural
General information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| Food cue exposure | Experimental | Not described Receives: Behavioral: Food cue exposure |
| Psycho-education | Active comparator | Not described Receives: Behavioral: Psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating in the absence of hunger
Self-reported \& behaviourally measured eating in the absence of hunger
Measured: 2 - 3 months
Binge eating
Self-reported binge eating
Measured: 2 - 3 months
Secondary outcomes (4)
Cue reactivity
Reactivity to food related cues, measured by food cravings and salivary responses
Measured: 2 - 3 months
Self-control and self-esteem
Self-reported self-control and self-esteem
Measured: 2 - 3 months
Dietary restraint, and eating, weight and shape concerns
Self-reported dietary restraint, and eating, weight and shape concerns
Measured: 2 - 3 months
BMI change
Body Mass Index change
Measured: 2 - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Insufficient number of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Anita Jansen, Professor, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796340
- Sponsor's protocol ID
- METC 13-2-009
- Other IDs
- NWO
- Status last verified
- Oct 2014
- First submitted
- 20 Feb 2013
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 2576871Jansen 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.
PubMed 1586360Jansen 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.
PubMed 9642846Toro 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.
PubMed 12898559Martinez-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.
PubMed 17607695Boutelle 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.
PubMed 22122291
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue Exposure Training for Overweight Children
- ClinicalTrials.gov ID
- NCT01796340
- Acronym / sponsor ID
- METC 13-2-009
- Conditions
- Overweight, Obesity
- Keywords
- cue exposure, childhood, overeating, overweight, obese, treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University, Netherlands Organisation for Scientific Research
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food cue exposure | Experimental | Behavioral: Food cue exposure |
| Psycho-education | Active comparator | Behavioral: Psycho-education |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Not being overweight (anymore, due to weight loss)
- Not able to speak and/or write Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food cue exposureParticipants 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. | Behavioural | Food cue exposure |
| Psycho-educationGeneral information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed. | Behavioural | Psycho-education |
Primary outcome
Eating in the absence of hunger
Time frame: 2 - 3 months
Self-reported \& behaviourally measured eating in the absence of hunger
Binge eating
Time frame: 2 - 3 months
Self-reported binge eating
4 secondary outcomes
Cue reactivity
Time frame: 2 - 3 months
Self-control and self-esteem
Time frame: 2 - 3 months
Dietary restraint, and eating, weight and shape concerns
Time frame: 2 - 3 months
BMI change
Time frame: 2 - 3 months
Results and safety
The study was stopped early (reason given: Insufficient number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Background: PubMed 2576871Jansen 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.
- Background: PubMed 1586360Jansen 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.
- Background: PubMed 9642846Jansen 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.
- Background: PubMed 12898559Toro 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.
- Background: PubMed 17607695Martinez-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.
- Background: PubMed 22122291Boutelle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Jansen, Professor principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food cue exposure and Psycho-education in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient number of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating in the absence of hunger (time frame: 2 - 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796340, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.