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Completed

NCT Number: NCT05071521

The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia

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).

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Key information

Age range

16 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princess Nourah Bint Abdulrahman University

Riyadh, 11671, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

undergraduate Saudi female

Exclusion criteria

undergraduate Saudi female with eating disorders

Treatment and study plan

The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention

Other

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 outcomes

  1. Eating Disorder Examination-Questionnaire (EDE-Q, version 6.0).

    Time frame: 5 months

    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 outcomes

  1. Body Shape Questionnaire (BSQ-8C).

    Time frame: 5 months

    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

  2. Brief Version of the Fear of Negative Evaluation Scale (BFNE).

    Time frame: 5 months

    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.

  3. Patient Health Questionnaire (PHQ-9).

    Time frame: 5 months

    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.

Sponsors and collaborators

Lead sponsor

University of Sheffield

Other

Collaborators

  • Princess Nourah Bint Abdulrahman University

Registry information

Official study title

The Effectiveness of a Dissonance-based Eating Disorders Prevention Programme for Saudi Young Women

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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