AzTrials
AzTrials

Eating DisordersNCT04626102

Healthy Eating Attitudes and Behaviours Group Program

A study testing Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition) in people with Eating Disorders and Body Image Disturbance, run by Istanbul Arel University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Eating disorders (ED) are serious mental health illnesses interfering psychological, physical and social well-being. Besides the severity of ED, most of the individuals presenting symptoms are either not detected or treated. Among ones undergoing treatment, full recovery and remission are also not very likely. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Eating Disorders, Body Image Disturbance
What is being tested?
Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2018to 30 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • having a score of EDEQ-Total or EAT - 40 higher than the mean average of female participants in a study conducted among university students in Turkey before
  • giving consent during the above-mentioned study for getting an invitation for participating in a study in which a group program for promoting healthy eating attitudes and behaviours.

Who cannot join

  • current or history of eating disorders diagnosis,
  • current substance abuse problem and/or current or past history of psychotic disorders.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Arel University

    Istanbul, Sefaköy-Küçükçekmece, 34295

Other trials in Turkey (Türkiye)

About this study

Official title: Healthy Eating Attitudes and Behaviours Group Program: A Randomised Controlled Feasibility Study

Eating disorders (ED) are serious mental health illnesses interfering psychological, physical and social well-being. Besides the severity of ED, most of the individuals presenting symptoms are either not detected or treated. Among ones undergoing treatment, full recovery and remission are also not very likely. Given many negative consequences of ED and personal, sociocultural and financial barriers for ED treatment and low rates of full recovery, any intervention for preventing the development and/or chronicization of ED would be a useful step for the improvement of public health.

Literature has established that Turkish people represent unhealthy eating attitudes and behaviours as similar to Western societies. Evidence shows that the prevalence of disordered eating attitudes and behaviours in Turkey changed between 2.2% to 12.8%. Prevalence of ED particularly among university students and these problems are also likely to negatively influence students' psychological, social and physical well-being, relationships with pairs, educational attainment and academic success. However, awareness regarding ED, help-seeking and receiving treatment appears to be less likely.

Read more

Since there is no ED prevention program available for university students in Turkey, it was aimed to develop a Cognitive Behaviour Therapy oriented 6 session ED prevention program (Healthy Eating Attitudes and Behaviours Group Program) for female university students presenting a high risk for ED. A further aim was to examine feasibility, acceptability and efficacy of this program.

Evidence-based clinical guidelines for ED have indicated that CBT is consistently recommended for all subtypes of ED, and CBT oriented prevention programs have been shown to result in a better outcome for university students. Therefore, it was expected that university students who participated in 6 session Healthy Eating Attitudes and Behaviours Group Program would present significantly greater reductions in ED related psychopathology, body dissatisfaction, emotion regulation difficulties and internalization and pressure of sociocultural attitudes towards appearance compared to participants in active control group condition (single session Eating Disorders and Body Dissatisfaction: A Group Work) and wait-list control condition. Also, it was expected that the level of acceptability and feasibility of 6 session Healthy Eating Attitudes and Behaviours Group Program would be good.

Being tested
Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition), Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)
Keywords
eating disorders, prevention, university students, cognitive behavioural
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)Behavioural

    The program has been developed by Clinical Psychologist Başak İnce and Psychiatrist Prof. Dr Başak Yücel. The session topics and contents of this program were based on the Fairburn (2008)'s book titled Cognitive- Behavior Treatment and Eating Disorders and 10-week online version of StudentBodies program designed by Saekow and her colleagues (2015). Program protocol was written based on Fairburn (2008)'s book titled Cognitive- Behavior Treatment and Eating Disorders and Fursland and her colleagues (2007)'s book titled Overcoming Disordered Eating.

    This program aimed to inform participants about the causes and consequences of eating disorders, teach cognitive and behavioural techniques to change their unhealthy eating attitudes and behaviours, and provide support during their attitudinal and behavioural changes. Each week, participants were asked to complete homework activities which were related to topics covered in each session.

  • Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)Behavioural

    This single-session group program was designed as an active control group for the purpose of this study. The content of the program was prepared based on Stice and his colleagues (2013)'s four - sessions Body Project eating disorders prevention program. This single-session program aimed to inform participants about causes and consequences of eating disorders, and discuss "thin ideal" messages created by media and the negative impact of these messages on women's body images, and address possible ways of countering these messages. Detailed information regarding the covered topics and video presentations in the group session is provided below.

Study groups in NCT04626102
Study groupRoleWhat they receive
EnrollmentNo interventionParticipants were recruited by using a convenience sampling method. Potential participants were reached through lecturers and professors who are teaching classes at different universities in Istanbul, Turkey. Participants were asked to fill out a questionnaire package covering Demographic Information Form, Eating Disorders Examination Questionnaire (EDEQ), Eating Attitudes Test - 40 (EAT-40), Body Image Satisfaction Questionnaire (BISQ), and Sociocultural Attitudes towards Appearance Questionnaire-4-Revised (SATAQ-4R). Filling out the questionnaire package took approximately 25-minutes.
Intervention PeriodExperimentalParticipants were randomly assigned to one of these conditions: Experimental condition: Healthy Eating Attitudes and Behaviours Group Program - 6 weekly sessions, each session was about 45-minutes to 60-minutes Active control condition: Eating Disorders and Body Dissatisfaction: A Group Work - single session about 1.5 hours to 2 hours Wait-list control condition: Participants in this condition were informed that they will be asked to fill out questionnaires that sent to them, and at the end of 6 months, they will be invited to participate in Healthy Eating Attitudes and Behaviours Group Program.
Receives: Behavioral: Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition); Behavioral: Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Eating Disorders Examination Questionnaire

    This questionnaire was used for measuring restraint eating, shape concern, weight concern, eating concern and general eating disorders related psychopathology. There are four subscales named Restraint, Eating Concern, Shape Concern and Weight Concern, and a total score. The minimum score for this scale is 0, while the maximum score is 6. Higher scores indicate greater levels of disordered eating attitudes and behaviours. This questionnaire was used to assess the level of change from baseline to post-treatment and from baseline to 1 month follow up.

    Measured: Arm1: Enrollment; Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)

  2. The Body Shape Questionnaire

    This questionnaire was used for measuring preoccupation with body weight and shape. Scores can range from 34 (minimum) to 204 (maximum). Higher scores indicate greater levels of body dissatisfaction. This questionnaire was used to assess the level of change from baseline to post-treatment and from baseline to 1 month follow up.

    Measured: Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)

Secondary outcomes (2)

  1. The Difficulties in Emotion Regulation Scale -16

    This questionnaire was used for measuring different aspects of emotion regulation difficulties. The minimum score for this scale is 0, while the maximum score is 64. Higher scores indicate greater levels of difficulty in emotion regulation. This questionnaire was used to assess the level of change from baseline to post-treatment and from baseline to 1 month follow up.

    Measured: Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)

  2. The Sociocultural Attitudes towards Appearance Questionnaire-4-Revised

    This questionnaire was used for measuring the influence of societal and interpersonal influences on body image and disturbances in eating behaviour. There are 7 subscales of this questionnaires: (1) Internalization: Thin/Low Body Fat, (2) Internalization: Muscular, (3) Internalization: General Attractiveness, (4) Pressures: Family, (5) Pressures: Media, (6) Pressures: Peers, and (7) Pressures: Significant Others. For each subscale, scores can range from 1 (minimum) to 5 (maximum). Higher scores indicate greater levels of internalization or pressures.

    This questionnaire was used to assess the level of change from baseline to post-treatment and from baseline to 1 month follow up.

    Measured: Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start1 Dec 2018
  3. Primary completion1 Apr 2019
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants were randomly assigned to 6-session Healthy Eating Attitudes and Behaviours Group Program (experimental group condition), single session Eating Disorders and Body Dissatisfaction: A Group Work (active control group condition) or wait-list control group condition.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626102
Sponsor's protocol ID
IstanbulArelU
Status last verified
Nov 2020
First submitted
30 Oct 2020
Last updated
12 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fairburn CG. Cognitive behavior therapy and eating disorders: Guilford Press. 2008. 323 p.

  • Kugu N, Akyuz G, Dogan O, Ersan E, Izgic F. The prevalence of eating disorders among university students and the relationship with some individual characteristics. Aust N Z J Psychiatry. 2006 Feb;40(2):129-35. doi: 10.1080/j.1440-1614.2006.01759.x.

    PubMed 16476130

  • Saekow J, Jones M, Gibbs E, Jacobi C, Fitzsimmons-Craft EE, Wilfley D, & Barr Taylor C. StudentBodies-eating disorders: A randomized controlled trial of a coached online intervention for subclinical eating disorders. Internet Interventions. 2015; 2(4): 419-428. doi:https://doi.org/10.1016/j.invent.2015.10.004

  • Stice E, Butryn ML, Rohde P, Shaw H, Marti CN. An effectiveness trial of a new enhanced dissonance eating disorder prevention program among female college students. Behav Res Ther. 2013 Dec;51(12):862-71. doi: 10.1016/j.brat.2013.10.003. Epub 2013 Oct 19.

    PubMed 24189570

  • Taylor CB, Bryson S, Luce KH, Cunning D, Doyle AC, Abascal LB, Rockwell R, Dev P, Winzelberg AJ, Wilfley DE. Prevention of eating disorders in at-risk college-age women. Arch Gen Psychiatry. 2006 Aug;63(8):881-8. doi: 10.1001/archpsyc.63.8.881.

    PubMed 16894064

  • Watson HJ, Joyce T, French E, Willan V, Kane RT, Tanner-Smith EE, McCormack J, Dawkins H, Hoiles KJ, Egan SJ. Prevention of eating disorders: A systematic review of randomized, controlled trials. Int J Eat Disord. 2016 Sep;49(9):833-62. doi: 10.1002/eat.22577. Epub 2016 Jul 18.

    PubMed 27425572

  • Yucel B, Polat A, Ikiz T, Dusgor BP, Elif Yavuz A, Sertel Berk O. The Turkish version of the eating disorder examination questionnaire: reliability and validity in adolescents. Eur Eat Disord Rev. 2011 Nov-Dec;19(6):509-11. doi: 10.1002/erv.1104. Epub 2011 Mar 13.

    PubMed 21400637

  • White S, Reynolds-Malear JB, Cordero E. Disordered eating and the use of unhealthy weight control methods in college students: 1995, 2002, and 2008. Eat Disord. 2011 Jul-Aug;19(4):323-34. doi: 10.1080/10640266.2011.584805.

    PubMed 22352972

  • Vardar E, Erzengin M. The prevalence of eating disorders (EDs) and comorbid psychiatric disorders in adolescents: a two-stage community-based study. Turk Psikiyatri Derg. 2011 Winter;22(4):205-12.

    PubMed 22143945

  • Stice E, Shaw H, Marti CN. A meta-analytic review of eating disorder prevention programs: encouraging findings. Annu Rev Clin Psychol. 2007;3:207-31. doi: 10.1146/annurev.clinpsy.3.022806.091447.

    PubMed 17716054

  • Schaefer LM, Harriger JA, Heinberg LJ, Soderberg T, Kevin Thompson J. Development and validation of the sociocultural attitudes towards appearance questionnaire-4-revised (SATAQ-4R). Int J Eat Disord. 2017 Feb;50(2):104-117. doi: 10.1002/eat.22590. Epub 2016 Aug 19.

    PubMed 27539814

  • Linardon J, Fairburn CG, Fitzsimmons-Craft EE, Wilfley DE, Brennan L. The empirical status of the third-wave behaviour therapies for the treatment of eating disorders: A systematic review. Clin Psychol Rev. 2017 Dec;58:125-140. doi: 10.1016/j.cpr.2017.10.005. Epub 2017 Oct 23.

    PubMed 29089145

  • Hay P. Current approach to eating disorders: a clinical update. Intern Med J. 2020 Jan;50(1):24-29. doi: 10.1111/imj.14691.

    PubMed 31943622

  • Griffiths S, Rossell SL, Mitchison D, Murray SB, Mond JM. Pathways into treatment for eating disorders: A quantitative examination of treatment barriers and treatment attitudes. Eat Disord. 2018 Nov-Dec;26(6):556-574. doi: 10.1080/10640266.2018.1518086. Epub 2018 Sep 17.

    PubMed 30222057

  • Gratz KL, & Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment. 2004; 26(1): 41-54. doi:10.1023/b:Joba.0000007455.08539.94

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition) in people with Eating Disorders and Body Image Disturbance, run by Istanbul Arel University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Eating Disorders Examination Questionnaire (time frame: Arm1: Enrollment; Arm2: Baseline(first day of the group intervention), post-treatment (6 weeks after baseline measurement), 1 month follow up (10 weeks after te baseline measurement)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04626102, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in