Back to resultsThe Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia
Primary Purpose
Eating Disorder Symptom and Body Image Dissatisfaction
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorder Symptom and Body Image Dissatisfaction
Eligibility Criteria
Inclusion Criteria:
undergraduate Saudi female
Exclusion Criteria:
undergraduate Saudi female with eating disorders
Sites / Locations
- Princess Nourah Bint Abdulrahman University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Eating disorders prevention
Healthy eating education
Arm Description
The Body Project. The Body Project is a dissonance-based eating disorders prevention programme. It is a manualised evidence-based programme that targets eating pathology and body image dissatisfaction in young women. The objective of the programme is to create cognitive dissonance to encourage participants to decrease pursuing ideal-thinness. It includes group discussion, written and behavioural exercises and role-play to achieve cognitive dissonance (Stice, Rohde, & Shaw, 2013). It involves four group sessions for an hour each in consecutive weeks. At the beginning of each meeting, the facilitator reinforces voluntary commitment. Homework is explained and given at the end of each meeting and reviewed at the beginning of the following meeting. References: Stice, E., Rohde, P., Shaw, H. (2013). The body project a dissonance-based eating disorders prevention intervention (updated edition). New York: Oxford University Press.
The control group were asked to read educational material in Arabic about healthy nutrition and active lifestyle from the Saudi branch of the World Obesity Federation (Kayl Association for Combatting Obesity, 2021). The material includes information about body mass index; easy ways to measure food units without a scale; benefits of working out; means to adopt healthier daily habits; and healthier food alternatives. The material was chosen because it was designed to be easy to understand by any individual. References: Kayl Association for Combatting Obesity. (2021). Kayl association for combatting obesity. Retrieved from https://www.kayl.org.sa
Outcomes
Primary Outcome Measures
Eating Disorder Examination-Questionnaire (EDE-Q, version 6.0).
The EDE-Q is a widely used self-report measure of eating disorder psychopathology (Fairburn & Beglin, 2008). It contains 28 items investigating eating disorder behaviours and attitudes during the past 28 days. It includes four subscales: dietary restraint; eating concerns; weight concerns; and shape concerns. The Global EDE-Q score (mean of the four attitudinal scores) and the scores of each subscales were used in this study. Higher scores indicate greater eating pathology. The scale was applied before and after the programme to assess outcomes.
Secondary Outcome Measures
Body Shape Questionnaire (BSQ-8C).
Body image dissatisfactions was measured using the BSQ-8C, which is a short version of the full Body Shape Questionnaire (Evans & Dolan, 1993). A higher score indicates higher levels of body image dissatisfaction. The scale was applied before and after the programme to assess outcomes
Brief Version of the Fear of Negative Evaluation Scale (BFNE).
The BFNE (Leary, 1983) measures anxiety related to perceived negative evaluation. A high score shows higher levels of social anxiety. The scale was applied before and after the programme to assess outcomes.
Patient Health Questionnaire (PHQ-9).
Depression was assessed with the PHQ-9 (Löwe et al., 2004), which measures the severity of depression over the past two weeks. Higher scores indicate greater levels of depression. The scale was applied before and after the programme to assess outcomes.
Full Information
NCT ID
NCT05071521
First Posted
September 17, 2021
Last Updated
September 27, 2021
Sponsor
University of Sheffield
Collaborators
Princess Nourah Bint Abdulrahman University
1. Study Identification
Unique Protocol Identification Number
NCT05071521
Brief Title
The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia
Official Title
The Effectiveness of a Dissonance-based Eating Disorders Prevention Programme for Saudi Young Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 7, 2021 (Actual)
Study Completion Date
March 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sheffield
Collaborators
Princess Nourah Bint Abdulrahman 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
The trial is a randomized control trial about the effective of an eating disorders prevention programmer for young Saudi women.
The prevention program is title The Body Project. Participants will be Saudi undergraduates from Princess Nourah Bint Abdulrahman University. Sample size is 64 participants. They will be divided randomly to two groups, each group has 32 participants. The first group is the intervention group where the prevention program will be provided. The second group will be the control group where healthy eating education material will be provided. The outcomes will be measured with adapted tools to local culture at three points (pre, post and 3 month follow-up).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder Symptom and Body Image Dissatisfaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eating disorders prevention
Arm Type
Active Comparator
Arm Description
The Body Project. The Body Project is a dissonance-based eating disorders prevention programme. It is a manualised evidence-based programme that targets eating pathology and body image dissatisfaction in young women. The objective of the programme is to create cognitive dissonance to encourage participants to decrease pursuing ideal-thinness. It includes group discussion, written and behavioural exercises and role-play to achieve cognitive dissonance (Stice, Rohde, & Shaw, 2013). It involves four group sessions for an hour each in consecutive weeks. At the beginning of each meeting, the facilitator reinforces voluntary commitment. Homework is explained and given at the end of each meeting and reviewed at the beginning of the following meeting.
References:
Stice, E., Rohde, P., Shaw, H. (2013). The body project a dissonance-based eating disorders prevention intervention (updated edition). New York: Oxford University Press.
Arm Title
Healthy eating education
Arm Type
Sham Comparator
Arm Description
The control group were asked to read educational material in Arabic about healthy nutrition and active lifestyle from the Saudi branch of the World Obesity Federation (Kayl Association for Combatting Obesity, 2021). The material includes information about body mass index; easy ways to measure food units without a scale; benefits of working out; means to adopt healthier daily habits; and healthier food alternatives. The material was chosen because it was designed to be easy to understand by any individual.
References:
Kayl Association for Combatting Obesity. (2021). Kayl association for combatting obesity. Retrieved from https://www.kayl.org.sa
Intervention Type
Other
Intervention Name(s)
The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention
Intervention Description
The Body Project is a a selective dissonance-based prevention program that targets women with body image concerns. It has been developed with University and similar populations in mind, making it appropriate to the current research.The Body Project is based on a protocol, and aims to create cognitive dissonance that encourages participants to reduce pursuit of the thin-ideal. It involves the use of a scripted manual, covering four interactive weekly sessions. These involve role play, behavioural, verbal and written exercises.
Primary Outcome Measure Information:
Title
Eating Disorder Examination-Questionnaire (EDE-Q, version 6.0).
Description
The EDE-Q is a widely used self-report measure of eating disorder psychopathology (Fairburn & Beglin, 2008). It contains 28 items investigating eating disorder behaviours and attitudes during the past 28 days. It includes four subscales: dietary restraint; eating concerns; weight concerns; and shape concerns. The Global EDE-Q score (mean of the four attitudinal scores) and the scores of each subscales were used in this study. Higher scores indicate greater eating pathology. The scale was applied before and after the programme to assess outcomes.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Body Shape Questionnaire (BSQ-8C).
Description
Body image dissatisfactions was measured using the BSQ-8C, which is a short version of the full Body Shape Questionnaire (Evans & Dolan, 1993). A higher score indicates higher levels of body image dissatisfaction. The scale was applied before and after the programme to assess outcomes
Time Frame
5 months
Title
Brief Version of the Fear of Negative Evaluation Scale (BFNE).
Description
The BFNE (Leary, 1983) measures anxiety related to perceived negative evaluation. A high score shows higher levels of social anxiety. The scale was applied before and after the programme to assess outcomes.
Time Frame
5 months
Title
Patient Health Questionnaire (PHQ-9).
Description
Depression was assessed with the PHQ-9 (Löwe et al., 2004), which measures the severity of depression over the past two weeks. Higher scores indicate greater levels of depression. The scale was applied before and after the programme to assess outcomes.
Time Frame
5 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
undergraduate Saudi female
Exclusion Criteria:
undergraduate Saudi female with eating disorders
Facility Information:
Facility Name
Princess Nourah Bint Abdulrahman University
City
Riyadh
ZIP/Postal Code
11671
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia
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