Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/12/2017
Date assigned
13/12/2017
Last edited
13/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Childhood obesity is a growing problem, and because of the severity of the negative consequences, it needs to be dealt with as soon as possible. The current treatments for childhood obesity are working, but only in short term and only moderately. Therefore, there is a need to search for the underlying mechanisms to improve the existing treatments. A possible underlying mechanism is emotion regulation. Emotion regulation refers to the processes by which people influence which emotions they have, when they have them, and how they experience and express these emotions. When high levels of stress are regulated in an inadequate way, this can contribute to the development of obesity. Three processes are playing a role. Stress increases the production of the hormone cortisol, which may result in accumulation of fat. Low grade inflammation triggered by emotional distress may result in increased food intake and obesity. Emotional eating (eating to satisfy emotional needs) is also higher in children and adults with obesity, in comparison with average weight individuals. The aim of this study is to find out whether emotion regulation training results in less emotional eating and improves maintenance of weight loss.

Who can participate?
Youngsters aged 10-14 who are involved in a residential obesity treatment program

What does the study involve?
Participants are randomly allocated to receive either care as usual or Emotion Regulation Training (ERT) on top of care as usual. The ERT consists of 10 weekly sessions. Booster sessions are given 1, 3, 6 and 9 months after the end of this training. The participants are tested before and after the training and at 6 and 12 months follow-up to measure their use of emotion regulation strategies and changes in eating behaviour.

What are the possible benefits and risks of participating?
It is expected that the youngsters who receive ERT will use more adaptive emotion regulation strategies with less emotional eating and maintenance of weight loss at 6 and 12 months follow up. Improving the current childhood obesity treatments is the purpose of this study. If the treatment is found to be effective, the next step is to use it in a larger group of treatment centers.

Where is the study run from?
Zeepreventorium (Belgium)

When is the study starting and how long is it expected to run for?
January 2017 to August 2020

Who is funding the study?
Bijzonder Onderzoeksfonds (Belgium)

Who is the main contact?
Mrs Taaike Debeuf
Taaike.Debeuf@UGent.be

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Taaike Debeuf

ORCID ID

Contact details

Henri Dunantlaan 2
Gent
9000
Belgium
+32 (0)9/264 64 12
Taaike.Debeuf@UGent.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BOF GOA 2017 000101

Study information

Scientific title

Improving weight control and long-term treatment effects in young adolescents with obesity via emotion regulation training

Acronym

Study hypothesis

The trialists expect that adding an emotion regulation training (ERT) to the care as usual results in:
1. The use of more adaptive emotion regulation strategies
2. Less emotional eating
3. Improved weight-loss maintenance
4. Better long-term treatment effects
compared to care as usual only (CAU-only), reflected in different outcome measures (see below) .

Ethics approval

Ethics Committee of the Ghent University Hospital - approval pending

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Childhood obesity

Intervention

The recruitment consists of two waves of children entering the clinic (2018 and 2019). At entrance in the inpatient treatment clinic (July-August 2018, 2019) and after consent, participants are randomly assigned to either the ERT+CAU condition or to a CAU-only control condition. Randomization is stratified on age and gender. Before the beginning of the ERT (September 2018, 2019), the baseline measurement is conducted (August 2018, 2019). The ERT runs from September (2018, 2019) till December (2018, 2019). After the ERT measurements will take place post training (December 2019, 2020), 6-month follow up (February, 2019, 2020) and 12-month follow up (August 2019, 2020).

The intervention concerns an emotion regulation training (ERT): a group training of 10 sessions (duration 2h per session) on top of care as usual, namely the Multidisciplinary Obesity Treatment (MOT). The 10 sessions will be spread over 10 weeks. The groups are formed with max. 4 to 5 children/adolescents.

The ERT (emotion regulation training) will be given at the start of the treatment in the residential treatment center. Booster sessions will be provided at 1 month, 3 months and 6 months after this training. After every session the participants will also receive homework, making them exercising the competence or emotion regulation strategy they learned.

The content of the ERT is based on the training of prof. dr. Mathias Berking (Berking, M. & Whitley, B. (2014). Affect Regulation Training: A Practitioners' Manual. Houten: Springer). In the first 5 training sessions, the following basic competencies are learned: exploring feelings; learning about the basic feelings and the intensity of these feelings; body scan (where do I feel these feelings in my body?); abdominal breathing; emotional awareness; psycho- education on the influences of thoughts – feelings and behavior on each other and psycho- education on the function of emotions: learning to see negative emotions as allies. In the next 4 sessions the participants will be learned each time 1 emotion regulation strategy: Distraction; Acceptance; Cognitive Reappraisal and Problem Solving. In the last session the basic competencies and the emotion regulation strategies will be recapitulated.

The CAU (care as usual) consists of:
1. Psycho-education on food and physical activity
2. Therapy sessions on diet/healthy eating
3. Physical activity (4h a day) and healthy food habits
4. Parents are involved in therapy
5. Protocols about psychological aspects: problem solving, social competencies and self-worth
6. Individual sessions with a psychologist (every 2 weeks = Cognitive Behavioral Therapy)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Changes in the use of emotion regulation strategies: as measured on:
1.1. The FEEL-KJ questionnaire, measured at baseline, post, 6 and 12 months
1.2. Idiosyncratic measures (diary), measured between each ERT session, weekly 10 times from September to December
1.3. An experimental test after a mood induction movie, measured at baseline and post training
2. Changes in psychophysiological measures that represent emotion regulation as measured by:
2.1. Heart rate variability, measured at baseline, post and 6 months
2.2. Cortisol levels, measured at baseline, post and 6 months
3. Changes in eating behavior as measured on:
3.1. The NVE questionnaire, child and parent reporting, measured at baseline, post, 6 and 12 months
3.2. The SSES and SEES questionnaire, measured at baseline, post, 6 and 12 months
3.3. Idiosyncratic measures (diary), measured between each ERT session, weekly 10 times from September to December
3.4. Experimentally with a foodlab after a mood induction movie, measured at baseline and post training
4. Changes in attention for eating cues as measured by:
4.1. An attentional task, measured at baseline and post training
5. Changes in metabolomics:
5.1. Blood (parameters are inflammation; energy (leptin, ghrelin); NPY, cholesterol and triglycerides), measured at baseline and 6 months
5.2. Feces, measured at baseline and 6 months

Secondary outcome measures

1. Weight index as measured by:
1.1. BMI, measured at baseline, post, 6 and 12 months
1.2. Waist, measured at baseline, post, 6 and 12 months
2. Psychological wellbeing as measured by:
2.1. Different questionnaires (CBCL, YSR, CDI), measured at baseline, 6 and 12 months
3. Sleep pattern as measured by:
3.1. The CRSQ, measured at baseline, 6 and 12 months

Overall trial start date

01/01/2017

Overall trial end date

31/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary obesity (minimum 60% overweight at intake for obesity treatment in the clinic)
2. Age between 10 and 14 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Comorbid medical disorders that cause (a part of) the weight gain (i.e. serious thyroid problems)
2. Youngsters with medical problems where obesity is secondary

Recruitment start date

01/03/2018

Recruitment end date

01/07/2019

Locations

Countries of recruitment

Belgium

Trial participating centre

Zeepreventorium
Koninklijke Baan 5
De Haan
8420
Belgium

Sponsor information

Organisation

Ghent University

Sponsor details

Faculty of Psychology and Educational Sciences
Department of Developmental
Personality and Social Psychology
Henri Dunantlaan 2
Gent
9000
Belgium

Sponsor type

University/education

Website

https://www.vopspsy.ugent.be/en/

Funders

Funder type

Research organisation

Funder name

Bijzonder Onderzoeksfonds

Alternative name(s)

Special Research Fund, BOF

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Belgium

Results and Publications

Publication and dissemination plan

1. First year next to data collection:
1.1. Writing information for participants and their parents (education folders and flyers)
1.2. Concept manuscript/protocol paper (June 2018)
1.3. Feasibility analysis
1.4. Making movies and homework assignments to use in the training (psycho- education)
2. Second year next to data collection and analyzing:
2.1. Writing guidelines and manual
2.2. Train the trainer materials
2.3. Distributing knowledge newsletter
2.4. Information for partners
2.5. Press communications
2.6. Manuscript on the effects of the ER training on weight, psychological concepts (stress, emotion regulation, emotional eating), on attention (eating cues) and the related psychophysiological measures, directly after training and at 6 and 12 months follow-up

IPD sharing statement
The data is saved on a server of the University Ghent. Three types of data will be stored: questionnaire data, behavioural data and physiological data. Raw data of the questionnaires and behavioural data will be saved as .txt files, the physiological data will be stored as .edf files. Data storage fact sheets are used to document the meta-data. These files describe the transition from raw data to processed data and contain information about the variables and the encompassing datasets. The data storage fact sheets are stored on the local server of the department of the UGhent. Data about the informed consents, and the file linking participants numbers and names/contact information will be collected in a password-protected file. In this study there will be personal or confidential data collected. No personal information of participants will be coupled to the gathered data in any way. Participants' codes will be in the entire study (with the informed consents as only exception). The personal information will be saved according the law of privacy of 08/12/92. Participants will be informed about this in the informed consent. For sharing data, a protected USB flash drive is provided, filtered according the limitations as stated in the privacy and ethical commissions.

Intention to publish date

31/08/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes