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Register:	ISRCTN
Last refreshed on:	19 March 2018
Main ID:	ISRCTN70907354
Date of registration:	06/02/2017
Prospective Registration:	Yes
Primary sponsor:	Romanian Authority for Scientific Research (CNCS-UEFISCDI)
Public title:	A mobile-based serious game for young adults with disordered eating
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
Date of first enrolment:	05/04/2017
Target sample size:	74
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN70907354
Study type:	Interventional
Study design:	Multi-center randomized placebo-controlled trial (Treatment)
Phase:

Countries of recruitment
Romania

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Ioana Podina
Address:	International Institute for the Advanced Studies of Psychotherapy and Applied Mental Health Babe?-Bolyai University Republicii Street, No 37 050657 Cluj-Napoca Romania
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Irresistible food cravings, emotional eating or binge eating
Mental and Behavioural Disorders
Irresistible food cravings, emotional eating or binge eating

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

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

Source(s) of Monetary Support

Romanian Authority for Scientific Research (CNCS-UEFISCDI)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	30/11/2017
URL:

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