Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2022 |
Main ID: |
ISRCTN51957280 |
Date of registration:
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05/02/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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ICARE-PREVENT: Effectiveness of an Internet based intervention for eating disorders and obesity for adolescents in school setting
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Scientific title:
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Evaluating and disseminating transdiagnostic preventive interventions for eating disorders and obesity for adolescents in school settings (ICare-Prevent) |
Date of first enrolment:
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01/09/2016 |
Target sample size:
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430 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN51957280 |
Study type:
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Interventional |
Study design:
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Multi-centre international randomised controlled trial to test (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Austria
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Spain
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Megan
Jones |
Address:
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Allgemeines Krankenhaus der Stadt Wien
Waehringer Gürtel 18-20
1090
Vienna
Austria |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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1. Eating Disorders
2. Obesity
Mental and Behavioural Disorders Eating Disorders and Obesity
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Intervention(s)
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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
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Primary Outcome(s)
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Intuitive Eating measured by Intuitive Eating Scale (IES) at baseline, 9 weeks, 6 and 12 months.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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No. 634757
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Source(s) of Monetary Support
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European Commission
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Ethics review
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Status:
Approval date:
Contact:
Ethics Commission of the Medical University of Vienna, 28/01/0216, ref: 2209/2015
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/08/2019 |
URL:
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