Condition category
Mental and Behavioural Disorders
Date applied
28/01/2016
Date assigned
05/02/2016
Last edited
03/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Body image concerns and chaotic eating behaviors such as unhealthy dieting and binge eating are becoming increasingly common in teenagers. These problems are common at both ends of the spectrum, with both eating disorders (such as anorexia and bulimia) and obesity. Adolescence is a particularly turbulent time, and studies have shown that being very overweight or underweight can dramatically lower self-esteem and mood. It is therefore very important to promote healthy eating and exercise habits to young people in order to prevent these conditions and their consequences. This study will test a new internet program which is geared towards promoting healthy eating and exercise, as well information about improving body image and to learning how to deal with difficult emotions. The aim of this study is to test the effectiveness of this program at preventing eating disorders and obesity in school age adolescents.

Who can participate?
All students aged 14 to 19 years old who attend participating Austrian and Spanish schools.

What does the study involve?
Schools that agree to participate in this study are assigned to one of two groups. All participants taking part complete an online questionnaire, which includes about eating and physical activity habits, attitudes towards weight and shape, feelings, self-esteem and quality of life. Students attending schools in the first group take part in the internet-based prevention program “Staying Fit”. Based on the results of the initial online-questionnaire, participants are allocated to one of two tracks to fit their specific needs (overweight students take part in a program geared towards weight management and healthy weight student take part in a program about healthy habits). Both tracks consist of eight modules where the participants learn how to build healthy eating and exercise habits, to improve their body image and to learn how to deal with difficult emotions. The participants are able to work on these modules (one 30 minute module per week) during school hours and/or at home. Following completion of the initial questionnaires, participants in the second group continue as normal and are not given access to the Staying Fit program for the 12 month study. After the end of the program as well as 6 and 12 months later, participants in both groups complete the online questionnaires again to see if there has been any change to their eating and exercise habits, diet, self-esteem and mood. At the end of the 12 month study, participants in the second group are given access to the “Staying Fit” program.

What are the possible benefits and risks of participating?
Participants who take part in the Staying Fit program may learn to better cope it difficult situations and learn to respect themselves as they are, helping them to feel better. The study could also lead to improved eating and exercise habits, which is beneficial for their health. There are no real risks of taking part however some participants may feel uncomfortable or embarrassing when answering certain questions in the questionnaires, although they are given the opportunity to talk about this with the team anonymously at any time.

Where is the study run from?
1. Medical University of Vienna (Austria)
2. Ferdinand-Porsche FernFH (Austria)
3. Jaume I University (Spain)
4. University of Valencia (Spain)

When is the study starting and how long is it expected to run for?
September 2015 August 2019

Who is funding the study?
European Commission (Belgium)

Who is the main contact?
1. Dr Megan Jones (scientific)
2. Professor Andreas Karwautz (scientific)
3. Professor Rosa Maria Banos Rivera (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Megan Jones

ORCID ID

http://orcid.org/0000-0002-0514-5888

Contact details

Allgemeines Krankenhaus der Stadt Wien
Waehringer Gürtel 18-20
Vienna
1090
Austria

Type

Scientific

Additional contact

Prof Andreas Karwautz

ORCID ID

http://orcid.org/0000-0001-9053-998X

Contact details

Allgemeines Krankenhaus der Stadt Wien
Waehringer Guertel 18-20
Vienna
1090
Austria

Type

Scientific

Additional contact

Prof Rosa Maria Banos Rivera

ORCID ID

http://orcid.org/0000-0003-0626-7665

Contact details

Universitat de València
Avda- Blasco Ibanez 21
Valencia
46010
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

No. 634757

Study information

Scientific title

Evaluating and disseminating transdiagnostic preventive interventions for eating disorders and obesity for adolescents in school settings (ICare-Prevent)

Acronym

ICare-Prevent

Study hypothesis

The internet-based prevention program reduces eating disorder and obesity risk for adolescents in the intervention groups compared to a control group.

Ethics approval

Ethics Commission of the Medical University of Vienna, 28/01/0216, ref: 2209/2015

Study design

Multi-centre international randomised controlled trial to test

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

1. Eating Disorders
2. Obesity

Intervention

Schools (upper secondary level) in Austria and Spain are approached and asked for participation in the study. Participating schools are randomly assigned to either the intervention or the control condition. All students of a school assigned to the intervention group will receive the “Staying Fit” prevention program. All students of a school assigned to the control group will do the assessments only.

Control group: Participants will complete online-questionnaires at four different time points (baseline, 9 weeks, 6 months, 12 months) assessing eating and physical activity habits, body image concerns, weight and height, food intake, depression, anxiety, self-esteem and health related quality of life. Completing the questionnaires take about 30 minutes. After the end of the study (after 12 months) participants of the control group receive access to the prevention program “Staying Fit”.

Intervention group: Participants will complete the same online-questionnaires as the control group. Based on the baseline assessment, participants will be assigned to one of two available tracks of the “Staying Fit” prevention program which will be provided via an online-platform. Overweight adolescents will be assigned to the “Staying Fit – Weight management” track. Normal weight adolescents will receive the “Staying Fit – Health Habits” track. Both tracks consist of 8 modules which take about 30 minutes to complete. The participants will work on these modules during school lessons and/or at home and they are asked to complete one module per week. In both program tracks, the participants will learn about healthy eating and physical activity habits, how to deal with difficult emotions and situations, how to build a healthy body image and how to critically analyse contents from media (like internet and TV). The participants will also be encouraged to do some little practical exercises concerning these topics (e.g. completing food and physical activity diaries, setting specific goals they would like to work on).

Differences between the “Staying Fit – Weight Management” and “Staying Fit – Healthy Habits” track are primarily in the language used to describe the content and exercises, rather than the content itself. In the Staying Fit-Weight management” track there is a bit more emphasize on the topics eating and physical activity whereas in the “Staying Fit-Health Habits” track there is a bit more emphasize on the topics dealing with difficult emotions and media literacy.

After completing the 8 program modules (that means after 9 weeks) as well as after 6 and 12 months the participants are invited to complete a follow-up online-questionnaire which contains mainly the same questions as in the baseline assessment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Intuitive Eating measured by Intuitive Eating Scale (IES) at baseline, 9 weeks, 6 and 12 months.

Secondary outcome measures

1. Eating disorder psychopathology is measured using the Eating Disorder Examination Questionnaire at baseline, 9 weeks, 6 and 12 months
2. Body image concerns are measured using the Weight Shape Concerns Scale (questionnaire for females) and the Male Body Image Concerns scale (questionnaire for males) at baseline, 9 weeks, 6 and 12 months
3. BMI is determined from height and weight measurements (self-rating) at baseline, 9 weeks, 6 months and 12 months
4. Food intake is measured using the Food Frequency Questionnaire at baseline, 9 weeks, 6 and 12 months
5. Physical Activity is measured using the International Physical Activity Questionnaire at baseline, 9 weeks, 6 and 12 months
6. Depression is measured using the Child Depression Inventory at baseline, 9 weeks, 6 and 12 months
7. Anxiety is measured using the State/Trait Anxiety Inventory at baseline, 9 weeks, 6 and 12 months
8. Self-Esteem is measured using the Rosenberg Self-Esteem Scale at baseline, 9 weeks, 6 and 12 months
9. Health Related Quality of Life is measured using Inventory of Life Quality of Children and Youth at baseline, 9 weeks, 6 months and 12 months

Overall trial start date

01/09/2015

Overall trial end date

31/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Students aged 14-19 years in Austrian and Spanish schools
2. Access to and ability to use a computer with Internet
3. Adolescents’ as well as parental informed consents are available

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

430

Participant exclusion criteria

1. Adolescents with a current diagnosed mental disorder and/or currently in treatment due to a mental disorder
2. Adolescents below a healthy body weight, as defined by BMI <18,5 or Ideal Body Weight (IBW) below 75% or with pronounced eating disorder symptoms

Recruitment start date

01/09/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Austria, Spain

Trial participating centre

Medical University of Vienna
Spitalgasse 23
Vienna
1090
Austria

Trial participating centre

Ferdinand-Porsche FernFH
Lothringerstraße 4-8
Vienna
1040
Austria

Trial participating centre

Universitat Jaume I de Castellon
Avenida de Vicent Sos Baynat s/n 12071 Castellón
Valencia
12071
Spain

Trial participating centre

Universitat de Valencia
Av. de Blasco Ibáñez, 13
Valencia
46010
Spain

Sponsor information

Organisation

Medical University of Vienna

Sponsor details

Spitalgasse 23
Vienna
1090
Austria

Sponsor type

University/education

Website

Organisation

University of Valencia

Sponsor details

Avda. Blasco Ibanez 13
Valencia
46010
Spain

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

A study protocol for this study should be submitted to an international peer-reviewed scientific journal by December 2016 at the latest. A final results report will be posted to the trial registry by August 2019. Further publications in scientific peer-reviewed journals will be prepared as soon as data collection and analyses is completed.

Intention to publish date

31/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes