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Healthy Eating Attitudes and Behaviours Group Program

Primary Purpose

Eating Disorders, Body Image Disturbance

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)
Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)
Sponsored by
Istanbul Arel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eating Disorders focused on measuring eating disorders, prevention, university students, cognitive behavioural

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Istanbul Arel University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Enrollment

Intervention Period

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 30, 2020
Last Updated
November 6, 2020
Sponsor
Istanbul Arel University
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04626102
Brief Title
Healthy Eating Attitudes and Behaviours Group Program
Official Title
Healthy Eating Attitudes and Behaviours Group Program: A Randomised Controlled Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Arel University
Collaborators
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Body Image Disturbance
Keywords
eating disorders, prevention, university students, cognitive behavioural

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Participants were informed that they are invited to attend a group intervention aiming to improve healthy eating attitudes and behaviours. However, they were not informed that they were invited because they had higher levels of disordered eating attitudes and behaviours than the others who were not invited. Also, they did not know that the real aim was to prevent development of eating disorders.
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enrollment
Arm Type
No Intervention
Arm Description
Participants 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.
Arm Title
Intervention Period
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Eating Disorders Examination Questionnaire
Description
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.
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)
Title
The Body Shape Questionnaire
Description
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.
Time Frame
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 Outcome Measure Information:
Title
The Difficulties in Emotion Regulation Scale -16
Description
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.
Time Frame
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)
Title
The Sociocultural Attitudes towards Appearance Questionnaire-4-Revised
Description
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.
Time Frame
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)
Other Pre-specified Outcome Measures:
Title
The Eating Attitudes Test - 40
Description
This questionnaire was used to measure disordered eating attitudes and behaviours. Score of 30 and greater indicates greater disordered eating attitudes.
Time Frame
Arm1: Enrollment
Title
The Group Feedback Form
Description
feedback form was designed in order to gather information about the satisfaction with the aspects of the group program (e.g., structure, helpfulness, content of the program, the quality/features of the group therapist).
Time Frame
Arm 2: Post-treatment (6 weeks after baseline measurement)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: current or history of eating disorders diagnosis, current substance abuse problem and/or current or past history of psychotic disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Başak Yücel, MD
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Arel University
City
Istanbul
State/Province
Sefaköy-Küçükçekmece
ZIP/Postal Code
34295
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Fairburn CG. Cognitive behavior therapy and eating disorders: Guilford Press. 2008. 323 p.
Results Reference
background
PubMed Identifier
16476130
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
24189570
Citation
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.
Results Reference
background
PubMed Identifier
16894064
Citation
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.
Results Reference
background
PubMed Identifier
27425572
Citation
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.
Results Reference
background
PubMed Identifier
21400637
Citation
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.
Results Reference
background
PubMed Identifier
22352972
Citation
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.
Results Reference
background
PubMed Identifier
22143945
Citation
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.
Results Reference
background
PubMed Identifier
17716054
Citation
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.
Results Reference
background
PubMed Identifier
27539814
Citation
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.
Results Reference
background
PubMed Identifier
29089145
Citation
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.
Results Reference
background
PubMed Identifier
31943622
Citation
Hay P. Current approach to eating disorders: a clinical update. Intern Med J. 2020 Jan;50(1):24-29. doi: 10.1111/imj.14691.
Results Reference
background
PubMed Identifier
30222057
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
472072
Citation
Garner DM, Garfinkel PE. The Eating Attitudes Test: an index of the symptoms of anorexia nervosa. Psychol Med. 1979 May;9(2):273-9. doi: 10.1017/s0033291700030762.
Results Reference
background
Citation
Fursland A, Byrne S, & Nathan P. Overcoming disordered eating. Centre for Clinical Interventions. 2007
Results Reference
background
PubMed Identifier
12711261
Citation
Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.
Results Reference
background
PubMed Identifier
7866415
Citation
Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
Results Reference
background
PubMed Identifier
21516551
Citation
Evans EJ, Hay PJ, Mond J, Paxton SJ, Quirk F, Rodgers B, Jhajj AK, Sawoniewska MA. Barriers to help-seeking in young women with eating disorders: a qualitative exploration in a longitudinal community survey. Eat Disord. 2011 May-Jun;19(3):270-85. doi: 10.1080/10640266.2011.566152.
Results Reference
background
PubMed Identifier
8477304
Citation
Evans C, Dolan B. Body Shape Questionnaire: derivation of shortened "alternate forms". Int J Eat Disord. 1993 Apr;13(3):315-21. doi: 10.1002/1098-108x(199304)13:33.0.co;2-3.
Results Reference
background
PubMed Identifier
27965879
Citation
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
Results Reference
background
PubMed Identifier
2375266
Citation
Cok F. Body image satisfaction in Turkish adolescents. Adolescence. 1990 Summer;25(98):409-13.
Results Reference
background
PubMed Identifier
26970730
Citation
Cihan B, Bozo O, Schaefer LM, Thompson JK. Psychometric properties of the Sociocultural Attitudes Towards Appearance Questionnaire-4-Revised (SATAQ-4R) in Turkish women. Eat Behav. 2016 Apr;21:168-71. doi: 10.1016/j.eatbeh.2016.03.003. Epub 2016 Mar 4.
Results Reference
background
PubMed Identifier
24821099
Citation
Ciao AC, Loth K, Neumark-Sztainer D. Preventing eating disorder pathology: common and unique features of successful eating disorders prevention programs. Curr Psychiatry Rep. 2014 Jul;16(7):453. doi: 10.1007/s11920-014-0453-0.
Results Reference
background
PubMed Identifier
18243893
Citation
Celikel FC, Cumurcu BE, Koc M, Etikan I, Yucel B. Psychologic correlates of eating attitudes in Turkish female college students. Compr Psychiatry. 2008 Mar-Apr;49(2):188-94. doi: 10.1016/j.comppsych.2007.09.003. Epub 2007 Dec 21.
Results Reference
background
PubMed Identifier
24411653
Citation
Brockmeyer T, Skunde M, Wu M, Bresslein E, Rudofsky G, Herzog W, Friederich HC. Difficulties in emotion regulation across the spectrum of eating disorders. Compr Psychiatry. 2014 Apr;55(3):565-71. doi: 10.1016/j.comppsych.2013.12.001. Epub 2013 Dec 7.
Results Reference
background
PubMed Identifier
27239096
Citation
Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
Results Reference
background

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