Eating Disorder Symptom and Body Image DissatisfactionNCT05071521
The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia
A study testing The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention in people with Eating Disorder Symptom and Body Image Dissatisfaction, run by University of Sheffield at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Symptom and Body Image Dissatisfaction
- What is being tested?
- The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2020to 7 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- undergraduate Saudi female
Who cannot join
- undergraduate Saudi female with eating disorders
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Princess Nourah Bint Abdulrahman University
Riyadh, 11671
About this study
Official title: The Effectiveness of a Dissonance-based Eating Disorders Prevention Programme for Saudi Young Women
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).
- Being tested
- The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Body Project: A Dissonance-Based Eating Disorder Prevention InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Eating disorders prevention | Active comparator | 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. Receives: Other: The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention |
| Healthy eating education | Sham comparator | 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 Receives: Other: The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (3)
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
Measured: 5 months
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.
Measured: 5 months
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Oct 2020
- Primary completion7 Mar 2021
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorder Symptom and Body Image DissatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sheffield
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071521
- Sponsor's protocol ID
- PNU
- Status last verified
- Oct 2020
- First submitted
- 17 Sep 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Dissonance-based Eating Disorders Prevention Programme for Saudi Young Women
- ClinicalTrials.gov ID
- NCT05071521
- Acronym / sponsor ID
- PNU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of SheffieldUniversity, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 7 Mar 2021 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eating disorders prevention | Active comparator | Other: The Body Project: A Dissonance-Based Eating Disorder Prevention InterventionThe 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. |
| Healthy eating education | Sham comparator | Other: The Body Project: A Dissonance-Based Eating Disorder Prevention InterventionThe 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 |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- undergraduate Saudi female
Key exclusion criteria (1 listed)
- undergraduate Saudi female with eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Body Project: A Dissonance-Based Eating Disorder Prevention InterventionThe 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. | Other | Eating disorders prevention, Healthy eating education |
Primary outcome
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.
3 secondary outcomes
Body Shape Questionnaire (BSQ-8C).
Time frame: 5 months
Brief Version of the Fear of Negative Evaluation Scale (BFNE).
Time frame: 5 months
Patient Health Questionnaire (PHQ-9).
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention in people with Eating Disorder Symptom and Body Image Dissatisfaction, run by University of Sheffield at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination-Questionnaire (EDE-Q, version 6.0). (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.