Condition category
Mental and Behavioural Disorders
Date applied
02/02/2017
Date assigned
06/02/2017
Last edited
06/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Disordered eating describes a variety of abnormal eating behaviors that, by themselves, do not warrant a diagnosis of an eating disorder but involve common features of eating disorders such as binge eating (overeating) or restrained eating (not eating enough). Some forms of disordered eating can limit a person's ability to change their lifestyle to improve their health, such as by dieting or avoiding weight gain. Disordered eating that prevents people from losing weight can be associated with several behavioral eating patterns, such as emotional eating which is, in essence, a way of coping with stress and unpleasant emotions through eating. SIGMA (the Self-help, Integrated and Gamified Mobile-phone Application) is an treatment program delivered using mobile phones (mHealth) to target overweight young adults that are at risk for obesity not only because of their weight, but also because of disordered eating habits. The app consists of four modules, one of which is in the form of a game that uses elements of cognitive behavioural therapy (CBT - a type of therapy that helps people to change the way they think and behave) to help change behavior and thoughts towards food. The aim of this study is to find out whether SIGMA can help people to change their behaviour and eat better.

Who can participate?
Overweight Romanian-speaking young adults that own an Android operating smartphone who have problems with eating (emotional, compulsive or unstoppable eating or cravings) and are feeling depressed.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the SIGMA program for eight weeks. This involves completing four of mHealth modules via a mobile phone app. The first module consists of education. The second module is a game which uses elements of CBT to help change behaviour and thought patterns relating to eating. The third module consists of motivational messages, relaxation tools and distraction techniques to prevent relapse in dieting, and the fourth module consists of self-monitoring and feedback. Those in the second group receive a modified version of the SIGMA app for eight weeks, which includes education but without the second module. At the start of the study and then again after eight weeks and three months, participants complete questionnaires about their eating habits and have body measurements taken.

What are the possible benefits and risks of participating?
Participants may benefit from the CBT element of the program, as this type of therapy has been shown to be very effective at treating a range of mental health problems. There are no direct risks involved with participating.

Where is the study run from?
1. Babeș-Bolyai University (Romania)
2. University of Bucharest (Romania)

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

Who is funding the study?
Romanian Authority for Scientific Research: CNCS-UEFISCDI (Romania)

Who is the main contact?
Dr Ioana Podina
ioana.r.podina@gmail.com

Trial website

http://sigma-mhealth.ro/en/

Contact information

Type

Scientific

Primary contact

Dr Ioana Podina

ORCID ID

Contact details

International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health
Babeș-Bolyai University
Republicii Street
No 37
Cluj-Napoca
050657
Romania

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PN-II-RU-TE-2014-4-2481

Study information

Scientific title

Rationale and study design of an evidence-based gamified mHealth intervention for weight management in young adults with disordered eating: A placebo-controlled randomized trial

Acronym

SIGMA trial

Study hypothesis

The SIGMA intervention will be significantly more effective in promoting change in maladaptive behaviors and cognitive styles, decreasing the maladaptive counterparts and increasing adaptive food-related behavioral and cognitive styles of response.

Ethics approval

Ethics Commission, Babes-Bolyai University, ref: 30599/06.02.2017

Study design

Multi-center randomized placebo-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 below to request a patient information sheet

Condition

Irresistible food cravings, emotional eating or binge eating

Intervention

Selected participants will be randomized in the intervention and control trial arms in a 1:1 ratio. An independent researcher will handle the randomization and the random sequence will be generated using a 1:1 allocation ratio via an online available random number generator (i.e., www.randomization.com). The randomization sequence will be concealed from the staff responsible for the enrollment and assignment of the participants in the trial arms, by using the sealed opaque envelopes method.

SIGMA intervention: The SIGMA intervention is designed to accommodate four mHealth modules, as follows:
1. The psychoeducation module, where information about the purpose of the app, as well as information about physical activity and dieting is provided
2. The gamified intervention module, consisting firstly in an explicit cognitive-behavioral intervention targeting conscious cognitive and behavioral contents, such as sabotaging thoughts regarding foods and maladaptive eating habits and secondly, in an implicit attention training intervention aimed at addressing an unconscious process, the biased attention towards appetizing stimuli
3. The Crisis & Relapse prevention module, aimed at preventing relapses in dieting, and consisting of motivational messages and coping strategies, relaxation tools and distracting strategies
4. The self-monitoring, feedback, and evolution module

Attention placebo control: Participants allocated to the attention placebo control condition will have full access to a modified version of the SIGMA app, which includes all the SIGMA modules except for the gamified intervention module, thus lacking the active/distinctive ingredients of the SIGMA app.

Both interventions are scheduled to take place for 8 weeks. The follow-up evaluation will take place 3 months after treatment conclusion.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Maladaptive cognitive styles are measured using the Eating Disorders Beliefs Questionnaire at baseline, 8 weeks and 3 months
2. Behavioral eating habits are measured using the Dutch Eating Behavior Questionnaire at baseline, 8 weeks and 3 months

Secondary outcome measures

1. Weight is measured using the SIGMA application’s embedded self-report forms at baseline, 8 weeks and 3 months
2. Body mass index (BMI) is measured using the SIGMA application’s embedded self-report forms at baseline, 8 weeks and 3 months
3. Physical activity levels are assessed by measuring the number of steps taken per day using the SIGMA application’s embedded pedometer at baseline, 8 weeks and 3 months
4. General mood is measured using the Positive and Negative Affect Schedule – Short Form at baseline, 8 weeks and 3 months

Overall trial start date

01/11/2016

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young overweight adults (25 ≤ BMI ≤ 29)
2. Age between 18 and 35 years
3. Non-clinical eating behaviors in the range of irresistible food cravings, emotional eating or binge eating.
4. Owning an Android compatible smartphone

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

74

Participant exclusion criteria

1. Presence of any medical condition incompatible with physical/dietary recommendations (including pregnancy and type 2 diabetes)
2. Presence of an eating disorder
3. The use of appetite influencing medication and/or current enrollment in other weight-management programs
4. Current depression or any form of psychotic disorder
5. Lack of access to an Android compatible smartphone

Recruitment start date

05/04/2017

Recruitment end date

30/06/2017

Locations

Countries of recruitment

Romania

Trial participating centre

Babes-Bolyai University
Faculty of Psychology and Educational Sciences No. 7 Sindicatelor Street
Cluj-Napoca
400029
Romania

Trial participating centre

University of Bucharest
Faculty of Psychology and Educational Sciences No. 90 Panduri Street
Bucharest
050663
Romania

Sponsor information

Organisation

Romanian Authority for Scientific Research (CNCS-UEFISCDI)

Sponsor details

Str. Mendeleev nr. 21-25
Bucharest
010362
Romania

Sponsor type

Research council

Website

http://www.cncs-nrc.ro/

Funders

Funder type

Research council

Funder name

Romanian Authority for Scientific Research (CNCS-UEFISCDI)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal with an intent to publish around one year after the overall trial end date.

IPD Sharing plan:
The datasets generated during and/or analyzed during the current study are/will be available upon request from ioana.podina@fpse.unibuc.ro

Intention to publish date

30/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes