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Healthy Eating Attitudes and Behaviours Group Program

Sponsor
Istanbul Arel University (Other)
Overall Status
Completed
CT.gov ID
NCT04626102
Collaborator
Istanbul University (Other)
38
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)
  • Behavioral: Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (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.
Primary Purpose:
Prevention
Official Title:
Healthy Eating Attitudes and Behaviours Group Program: A Randomised Controlled Feasibility Study
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Enrollment

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.
Experimental: Intervention Period

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.

Behavioral: Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)
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.

Behavioral: Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)
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.

Outcome Measures

Primary Outcome Measures

  1. The Eating Disorders Examination Questionnaire [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)]

    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.

  2. The Body Shape Questionnaire [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)]

    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

  1. The Difficulties in Emotion Regulation Scale -16 [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)]

    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.

  2. The Sociocultural Attitudes towards Appearance Questionnaire-4-Revised [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)]

    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.

Other Outcome Measures

  1. The Eating Attitudes Test - 40 [Arm1: Enrollment]

    This questionnaire was used to measure disordered eating attitudes and behaviours. Score of 30 and greater indicates greater disordered eating attitudes.

  2. The Group Feedback Form [Arm 2: Post-treatment (6 weeks after baseline measurement)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Arel University Istanbul Sefaköy-Küçükçekmece Turkey 34295

Sponsors and Collaborators

  • Istanbul Arel University
  • Istanbul University

Investigators

  • Study Director: Başak Yücel, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Başak İnce, Research Assistant, Istanbul Arel University
ClinicalTrials.gov Identifier:
NCT04626102
Other Study ID Numbers:
  • IstanbulArelU
First Posted:
Nov 12, 2020
Last Update Posted:
Nov 12, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Başak İnce, Research Assistant, Istanbul Arel University
eating disorders
prevention
university students
cognitive behavioural
Additional relevant MeSH terms:
Feeding and Eating Disorders

Study Results

No Results Posted as of Nov 12, 2020