Healthy Eating Attitudes and Behaviours Group Program

November 6, 2020 updated by: Başak İnce, Istanbul Arel University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sefaköy-Küçükçekmece
      • Istanbul, Sefaköy-Küçükçekmece, Turkey, 34295
        • Istanbul Arel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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 Body Shape Questionnaire
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)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
The Difficulties in Emotion Regulation Scale -16
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)
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.
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 Sociocultural Attitudes towards Appearance Questionnaire-4-Revised
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)

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Eating Attitudes Test - 40
Time Frame: Arm1: Enrollment
This questionnaire was used to measure disordered eating attitudes and behaviours. Score of 30 and greater indicates greater disordered eating attitudes.
Arm1: Enrollment
The Group Feedback Form
Time Frame: 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).
Arm 2: Post-treatment (6 weeks after baseline measurement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Arel University

Collaborators

Istanbul University

Investigators

  • Study Director: Başak Yücel, MD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulArelU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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