Condition category
Mental and Behavioural Disorders
Date applied
25/02/2016
Date assigned
26/02/2016
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Eating disorders are a group of common conditions which are defined by an abnormal attitude towards food. Anyone can develop and eating disorder although they are far more common in women, particularly between the ages of 12 and 20. Dietary restriction (avoiding certain foods) and body dissatisfaction (poor body image) are well known risk factors for developing eating disorders as well as eating-related health problems such as obesity. Studies have shown that prevention programs for those at risk of developing an eating disorder can be very effective. The programs mainly focus on changing attitudes and behaviors in order to encourage a healthier lifestyle and attitude towards food. “everyBody” s an internet-based program which aims to encourage healthy behavior and eating disorder prevention. There are various variations of the program, in order to provide tailored help to women with different risk factors, such as those with poor body image, those who binge and purge (overeat and then intentionally get rid of the food, such as by vomiting) or those who are restrict what they eat. The aim of this study is to find out whether women who take part in the “everyBody” program is an effective way to help women improve their body confidence and encourage healthier eating behaviors.

Who can participate?
Healthy women over 18 years of age.

What does the study involve?
At the start of the study, participants are individually screened for eating disorders. The participants are then allocated to one of five groups based on their respective needs and conditions. Each of the groups takes part in variations of the “everyBody” program, which involves internet-based sessions including discussion groups and education. The first group is for women with a BMI between 21 and 25 who have concerns about their weight and body shape. These women take part in eight weekly sessions in which the aim is to improve their body image. The second group is for women with a BMI greater than 18.5 who occasionally binge eat and/or purging (i.e. making themselves sick or using laxatives). These women take part in eight weekly sessions which aim to reduce binge eating and/or purging, along with improving body image, as well as receiving personal feedback. The third group is for women with a BMI of 18.5 to 21 who have concerns about their weight and body shape. These women take part in 10 weekly sessions which aim to stop cutting things out of their diet (dietary restriction) and improve body image, as well as receiving personal feedback. The forth group is for women with a BMI of 18.5 to 25 who show no signs relating to eating disorders. These women attend four weekly sessions without any additional guidance. The fifth group is for women with a BMI of over 25 (overweight). These women take part in 12 weekly sessions which promote healthy weight regulation, healthy eating and exercise habits. Participants in all groups complete a number of questionnaires at the start of the study, at the end of the “everyBody” program, and then again 6 and 12 weeks later, in order to assess the effectiveness of the different variations of the program.

What are the possible benefits and risks of participating?
Participants may benefit from receiving bonus money or prizes from their health insurance provider upon completion of the program. There are no notable risks involved with taking part in this study.

Where is the study run from?
Technical University Dresden (Germany)

When is the study starting and how long is it expected to run for?
September 2015 to August 2018

Who is funding the study?
European Union's Horizon 2020 Framework Programme for Research and Innovation (Belgium)

Who is the main contact?
1. Professor Corinna Jacobi (scientific)
corinna.jacobi@tu-dresden.de
2. Dr Ina Beintner (scientific)
ina.beintner@tu-dresden.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Corinna Jacobi

ORCID ID

http://orcid.org/0000-0002-0982-0596

Contact details

Technische Universität Dresden
Klinische Psychologie und Psychotherapie
Chemnitzer Straße 46a
Dresden
01187
Germany
+49 351 463 38576
corinna.jacobi@tu-dresden.de

Type

Scientific

Additional contact

Dr Ina Beintner

ORCID ID

http://orcid.org/0000-0003-1779-9878

Contact details

Technische Universität Dresden
Klinische Psychologie und Psychotherapie
Chemnitzer Straße 46a
Dresden
01187
Germany
+49 351 463 37460
ina.beintner@tu-dresden.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Tailored online health promotion and eating disorder prevention for women at different risk stages aiming to reduce weight and shape concerns

Acronym

Study hypothesis

Women who participate in the "everyBody" tailored online intervention for health promotion and eating disorder prevention will show statistically significant lower weight and shape concerns at post intervention compared to baseline.

Ethics approval

TU Dresden Ethics Committee, 23/02/2016, ref: EK83032016

Study design

Single centre non-randomized parallel group interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Internet

Trial type

Prevention

Patient information sheet

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

Condition

Eating disorders

Intervention

Based on the individual screening result, participants will be allocated to one of the five parallel intervention groups. Women with full-syndrome eating disorders will be excluded from participation and receive a treatment referral. Following informed consent and baseline assessment of primary and secondary outcomes each group obtains access to an evidence-based online prevention program tailored to their respective needs and conditions: everyBody Original, everyBody Basic, everyBody Plus, everyBody AN and everyBody Fit. All programs offer psychoeducation and behavioral exercises aiming to promote or establish healthy eating and exercise habits as well as improve self-esteem.

EveryBody Original targets women with a BMI from 21 to 25 who report elevated weight and shape concerns, but no other symptoms of an eating disorder. Participants from this group receive 8 weekly intervention sessions and get access to a moderated group discussion board. An additional aim in this group is the improvement of body image.

EveryBody Plus targets women with a BMI greater than 18.5 who report occasional binge eating and/or compensatory behaviors. Participants from this group receive 8 weekly intervention sessions, get access to a moderated group discussion board and receive weekly personal feedback. Additional aims in this group are the reduction of binge eating and/or purging and improvement of body image.

EveryBody AN targets women with a BMI ranging from 18.5 to 21 who report elevated weight and shape concerns but no other eating disorder symptoms. Participants from this group receive 10 weekly intervention sessions, get access to a moderated group discussion board and receive weekly personal feedback. Additional aims in this group are the reduction of dietary restraints and improvement of body image.

EveryBody Basic targets women with a BMI from 18.5 to 25 without elevated weight and shape concerns or other symptoms of an eating disorder. Participants from this group receive 4 weekly intervention sessions without guidance.

EveryBody Fit targets women with a BMI greater than 25 and promotes healthy weight regulation, healthy eating and exercise habits. Participants from this group receive 12 weekly intervention sessions and get access to a moderated group discussion board.

Participants are followed up post-intervention and at 6 and 12 months follow-up in all groups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Weight and shape concerns (measured with Weight Concerns Scale) at baseline and post-intervention

Secondary outcome measures

1. Weight and shape concerns are measured using the Weight Concerns Scale at baseline, 6 and 12 months follow up (effectiveness)
2. Core eating disorder symptoms (binge eating, compensatory behaviors are measured by self-report (questionnaire) at baseline, post-intervention, 6 and 12 months follow up (effectiveness)
3. Self-esteem is measured using the Rosenberg Self Esteem-Scale at baseline, post intervention, 6 and 12 months follow up
4. Quality of life is measured using the Assessment of Quality of Life-8D questionnaire at baseline, post intervention, 6 and 12 months follow up
5. The reach of the program is measured using sociodemographic variables (questionnaire) of participants at baseline
6. The adoption of the program is measured qualitatively by analyzing communication with stakeholders pre-intervention
7. The implementation of the program is measured by analyzing access paths, cost per recruit and participants adherence to the program before, during and post intervention
8. The maintenance of the program on a participant level is measured by assessing primary and secondary effectiveness outcomes
9. The maintenance of the program on a setting level is qualitatively assessed by analyzing stakeholder attempts to deliver the intervention at their own expense after recruitment for the study is completed

Overall trial start date

01/09/2015

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 or older
2. Female
3. Access to Internet
4. Informed consent (online)

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

4160

Participant exclusion criteria

1. Individuals reporting binge eating and/or compensatory behaviours more than once a week
2. Underweight individuals (BMI less than 18.5)

Recruitment start date

15/04/2016

Recruitment end date

30/11/2017

Locations

Countries of recruitment

Austria, Germany, Luxembourg, Switzerland

Trial participating centre

Technical University Dresden (Technische Universität Dresden)
Institute of Clinical Psychology and Psychotherapy
Dresden
01187
Germany

Sponsor information

Organisation

Technical University Dresden (Technische Universität Dresden)

Sponsor details

Institut für Klinische Psychologie und Psychotherapie
Professur Grundlagen und Interventionen von Essstörungen und assoziierten Störungen
Chemnitzer Str. 46a
Dresden
01187
Germany
+49 351 463 38576
corinna.jacobi@tu-dresden.de

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

European Union's Horizon 2020 Framework Programme for Research and Innovation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. The study protocol as well as at least one paper on results will be submitted to an international peer-reviewed scientific journal by September 2019 at the latest
2. The project website which will inform the public and stakeholders about the progress of the study is currently under construction

Intention to publish date

31/08/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.