Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/05/2018
Date assigned
22/05/2018
Last edited
21/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Many people with eating and weight disorders find it difficult to make changes to their eating habits. Two new computer trainings have had promising effects on reducing symptoms when attention processes are trained. This study is designed to compare the effects on treatment outcomes of two different attention trainings for overweight/obesity, to determine the impact of such training on people in the short and longer term and gain insights on how this might work.

Who can participate?
Males or females who are 18 years old or older and are currently overweight or obese

What does the study involve?
Participants answer questions about their eating behaviour and emotions, complete some computer and behavioural tasks, and have their height and weight measured. They are then asked to participate in the training sessions. They are randomly allocated to either an Attention Bias Modification Training, a Mindfulness Based Intervention, or a waiting list. The trainings consists of eight weekly sessions in the lab, and daily short trainings at home. The lab sessions last for about 30 minutes and the home trainings are 10 minutes long. For the home sessions, participants are provided with an electronic tablet at the beginning of the study to complete the trainings and return it at the end of the 8 weeks. At the end of the training sessions (on week eight), participants undergo a similar assessment to the one at the beginning of the trainings. Lastly, four weeks after having completed the training, participants are contacted by email with a brief questionnaire to be filled in online. They have the option to stop the study at any time.

What are the possible risks and benefits of participating?
There may be some slight discomfort associated with completing questionnaires evaluating eating behaviour and emotions, although all the questionnaires are very widely used and usually do not cause distress. This is an experimental study, the outcomes of which can inform on future treatment options that contribute to eating and weight disorders. The trainings have been shown to be effective in other studies, and are designed to help with eating habits and anxiety around food and eating.

Where is the study running from?
King’s College London (UK)

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

Who is funding the study?
National Council of Science and Technology (Mexico)

Who is the main contact?
Ms Daniela Mercado
Daniela.mercado_beivide@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Daniela Mercado Beivide

ORCID ID

http://orcid.org/0000-0003-1319-8362

Contact details

De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)2078485608
daniela.mercado_beivide@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS Project ID: 241656

Study information

Scientific title

A randomised controlled feasibility study of food related computerised attention training for obesity versus active (mindfulness-based intervention [MBI] and waiting list control [FOCUS])

Acronym

FOCUS

Study hypothesis

1. This study design will be feasible and acceptable for participants with overweight/obesity
2. MBI will improve general attention control and will reduce food-related AB (in comparison to ABMT). Moreover, it will have higher effect sizes in reducing anxiety symptoms, and will lead to a reduction in overeating and to weight loss

Ethics approval

Not provided at time of registration

Study design

Single-centred randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Overweight/obesity

Intervention

After baseline assessment, participants will be randomly allocated to either Attention Bias Modification Training (ABMT), Mindfulness, Based Intervention (MBI) or a waiting list condition. To balance groups for body weight, randomisation will be stratified by BMI (above or below 30 kg/m2) and by gender. Participants assigned to either condition will be asked to attend the Institute of Psychiatry, Psychology and Neuroscience eight times during an 8-week period (i.e. once a week).

The ABMT condition will last approximately 30 min. per visit and will implicitly train participants to “look towards” low calorie food using a modified version of the anti-saccade task while eye movements are recorded to assess participants' accuracy.

The MBI (provided by a company called Headspace) will last approximately 20 min. per training and will guide participants through a series of breathing exercises focusing on the present moment. In addition, participants allocated to the MBI condition will be asked to bring their favourite food (snack) increasing in calorie content as the training progresses (i.e. low, medium and high calorie), and will be guided to mindfully analyse it, focusing on its characteristics before eating it.

Participants from both training conditions will be asked to complete a Visual Analogue Scale (VAS) measuring hunger and craving.

For home sessions, participants will be given a tablet (Asus ZenPad 10) with the allocated training for a daily 10 min session using an app based ABMT or Headspace.

Participants allocated to the waiting list condition will be asked to wait for 8 weeks after baseline assessment and then they will be asked if they wish to receive either ABMT or MBI for 8 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. The feasibility of conducting a large scale RCT of attention trainings in overweight/obese patients by assessing recruitment, attendance, and retention rates. An acceptability and credibility questionnaire will be administered at post-assessment (i.e., week 8)
2. The quality, completeness, and variability of the outcome measures, determined using descriptive statistical analyses and graphical methods

Secondary outcome measures

Weight, eating behaviour and cognition before and after trainings. Assessment of these outcome measures will include different self-report questionnaires:
1. Hunger, craving, mood, stress and anxiety levels, measured using the Visual Analogue Scale (VAS)
2. Eating behaviour and awareness, assessed using the Food Craving Questionnaire – Trait version (FCQ-T), the Eating Disorders Examination Questionnaire (EDEQ), the Power of Food scale, the Mindful Eating Questionnaire (MEQ) and Mindful Awareness and Attention Scale (MAAS)
3. General psychopathology measured using the Depression, Anxiety and Stress Scale (DASS-21) and the State and Trait Anxiety Inventory (STAI)
4. Quality of diet and calorie intake assessed using 24h dietary recall questionnaire
5. BMI and body composition calculated by taking height and weight on the day of the assessment using a bioelectrical impedance scale
6. Different components of attention (i.e. alerting, orienting and executive attention) assessed by the food-Attention Network Task (Food-ANT)
7. Attention bias for food, measured by a dot-probe task while recording eye movements
8. Preference of low vs high-calorie food items, assessed using the food-choice task
9. State levels of cue-elicited food cravings, assessed using the Food Challenge Task
10. Food intake measured by the Bogus Taste Test, where participants will be asked to rate different kinds of highly palatable food in terms of their visual attractiveness, smell and taste and will be told that they should try as much of the offered items as they like. Food consumption will be determined by weighing remaining food.


All of these measures will be taken both at baseline assessment and post-assessment (8 weeks) with the exception of the EDEQ and the Power of Food Scale, which will also be completed by participants at follow-up (week 12). The size of the treatment effect on each outcome measure will be the difference in outcome data between conditions at post treatment (8 weeks) and follow-up (12 weeks). Group differences will be estimated using linear mixed effects regression models, controlling for the baseline level of the outcome and the strata variable used in the randomisation.

The aim is not to determine significant group differences but to establish a suitably precise effect size for the primary outcome at the post treatment assessment. This estimate will be used to guide the sample size of a future efficacy trial.

Overall trial start date

01/06/2017

Overall trial end date

01/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male or female participants
2. 18 years old or older (women of childbearing age will be included)
3. BMI of >25kg/m2
4. Fluent in English
5. Informed consent (written and witnessed)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45 participants (15/arm)

Participant exclusion criteria

1. Having a current other major psychiatric disorder (e.g., major depression, major suicidality, substance dependence, psychosis) needing treatment in its own right
2. Having a diagnose of Anorexia Nervosa, Bulimia Nervosa or Eating disorder not otherwise specified (EDNOS)
3. Diagnosis of Diabetes Mellitus
4. Having recently started psychotropic medication or increased the dose (i.e. within the previous 2 weeks)
5. Taking medication for weight loss
6. Pregnancy (either current or during the past 6 months)
7. Regular current or past mindfulness meditation or yoga practice (defined as > 20 minutes, twice or more times per week during the past 2 months).
8. Visual impairments that cannot be corrected with contact lenses or glasses

Recruitment start date

01/10/2018

Recruitment end date

01/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Consejo Nacional de Ciencia y Tecnología

Alternative name(s)

National Council of Science and Technology, Mexico, CONACYT

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Mexico

Results and Publications

Publication and dissemination plan

Study protocol in intended to be published in a high-impact peer reviewed journal (manuscript in progress). Planned publication of the study results in a high-impact peer reviewed journal. The intended date of publication is 01/05/2021.

IPD sharing statement
Once the study has finished and data has been published, anonymised data could be shared upon direct request to the PI (Ulrike.schmidt@kcl.ac.uk). Participants will agree to this by signing the consent form which state the possibility of anonymised data sharing.

Intention to publish date

01/05/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes