Body Image DisorderNCT04103606
A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students
A study testing GGBI: Positive Body Image (Mobile App) in people with Body Image Disorder and Body Dysmorphic Disorders, run by University of Padova at 1 site in Italy.
Trial summary
Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image Disorder, Body Dysmorphic Disorders, Eating Disorders
- What is being tested?
- GGBI: Positive Body Image (Mobile App)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2019to 31 Dec 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of Body Image Disorder symptoms
Who cannot join
- Presence of a full-blown Body Image Disorder
- Presence of a psychotic/schizophrenic disorder
- Current treatment for a Body Image Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Psychological Features in Female University Students: a Randomized Controlled Pilot Study with Crossover Design
Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs).
Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "GGBI: Positive Body Image" in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).
- Being tested
- GGBI: Positive Body Image (Mobile App)
- Medical subject headings
- Body Dysmorphic Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GGBI: Positive Body Image (Mobile App)Device
Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features
| Study group | Role | What they receive |
|---|---|---|
| immediate-use App group (iApp group) | Experimental | Participants in the iApp group start using the app immediately (Time 0; T0) for 16 consecutive days (until Time 1; T1). Receives: Device: GGBI: Positive Body Image (Mobile App) |
| delayed-use App group (dApp) | Active comparator | Participants in the dApp group start using the app at Time 1 (T1; 16 days after the iApp group) and use the app for the following 16 days (Time 2; T2). Receives: Device: GGBI: Positive Body Image (Mobile App) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body dissatisfaction and body dysmorphic disorder symptoms
Assessed with the Questionario sul Dismorfmismo Corporo (Questionnaire about Body Dysmorphic Disorder; QDC; Cerea et al., 2017), a self-report questionnaire assessing body dissatisfaction and body dysmorphic disorder symptoms made up of 40 items. Items are rated on a 7-point Likert scale (from 1 = strongly disagree to 7 = strongly agree; score range: 40-280), with higher scores indicating extreme body dissatisfaction and body dysmorphic disorder symptoms. Individuals who score above the cut-off of the questionnaire (QDC total score = 130) should be referred for further assessment because they might present extreme body dissatisfaction/body dysmorphic disorder symptoms or may be at risk of developing body dysmorphic disorder
Measured: 16 days
Change of eating attitudes and behaviors
Eating Disorder Inventory-3 (EDI-3; Garner, 2004; Italian version by Giannini et al., 2008): a self-report questionnaire assessing eating disorders core features made up of 91 items on a 6-point Likert scale (from always to never), with higher scores indicating higher eating disorder symptoms. It contains three primary subscales: Drive for Thinness (score range = 0-28; higher scores indicating higher drive for thinness), Bulimia (score range = 0-32; higher scores indicating higher bulimic symptoms), and Body Dissatisfaction (score range = 0-40; higher scores indicating higher body dissatisfaction). These subscales compose the Eating Disorder Risk Composite (EDRC) score. The other nine additional scales are Low Self-Esteem, Personal Alienation, Interpersonal Insecurity, Interpersonal Alienation, Interoceptive Deficits, Emotional Dysregulation, Perfectionism, Asceticism, and Maturity Fears.
Measured: 16 days
Secondary outcomes (2)
Change of self-esteem
Assessed with the Rosenberg Self Esteem Scale (RSES; Rosenberg, 1965; Italian version by Prezza, Trombaccia, and Armento, 1997), a self-report questionnaire assessing self-esteem. The Rosenberg Self Esteem Scale is made up of 10 items rated on a 4-point Likert scale (from 1 = "strongly disagree" to 4 = "strongly agree" ), with higher scores indicating higher self-esteem
Measured: 16 days
Change in social anxiety symptoms
Assessed with the Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998; Italian version by Sica, Musoni, Bisi, Lolli, \& Sighinolfi, 2007), a self-report questionnaire assessing social anxiety symptoms. The Social Interaction Anxiety Scale made up of 19 items on a 5-point Likert scale (from 0 = "not at all characteristic of true of me" to 4 = "extremely characteristic of true of me"; score range: 0-76); higher scores indicate higher levels of social interaction anxiety symptoms
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start30 Jan 2019
- Primary completion31 Jul 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisorderStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Cerea, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103606
- Sponsor's protocol ID
- 2936
- Status last verified
- Dec 2022
- First submitted
- 20 Sep 2019
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Psychological Features in Female University Students: a Randomized Controlled Pilot Study with Crossover Design
- ClinicalTrials.gov ID
- NCT04103606
- Acronym / sponsor ID
- 2936
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Sep 2019 (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.
Body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating Disorders (EDs). The aim of the trial is to test the effect of a mobile health application called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing Body Image Disorders (BIDs).
Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "GGBI: Positive Body Image" in this phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the investigators expect that participants gains in the iApp group would be maintained at follow-up (Time 2; T2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate-use App group (iApp group) | Experimental | Device: GGBI: Positive Body Image (Mobile App)Participants in the iApp group start using the app immediately (Time 0; T0) for 16 consecutive days (until Time 1; T1). |
| delayed-use App group (dApp) | Active comparator | Device: GGBI: Positive Body Image (Mobile App)Participants in the dApp group start using the app at Time 1 (T1; 16 days after the iApp group) and use the app for the following 16 days (Time 2; T2). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Presence of Body Image Disorder symptoms
Key exclusion criteria (3 listed)
- Presence of a full-blown Body Image Disorder
- Presence of a psychotic/schizophrenic disorder
- Current treatment for a Body Image Disorder
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 |
|---|---|---|
| GGBI: Positive Body Image (Mobile App)Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features | Device | delayed-use App group (dApp), immediate-use App group (iApp group) |
Primary outcome
Change of body dissatisfaction and body dysmorphic disorder symptoms
Time frame: 16 days
Assessed with the Questionario sul Dismorfmismo Corporo (Questionnaire about Body Dysmorphic Disorder; QDC; Cerea et al., 2017), a self-report questionnaire assessing body dissatisfaction and body dysmorphic disorder symptoms made up of 40 items. Items are rated on a 7-point Likert scale (from 1 = strongly disagree to 7 = strongly agree; score range: 40-280), with higher scores indicating extreme body dissatisfaction and body dysmorphic disorder symptoms. Individuals who score above the cut-off of the questionnaire (QDC total score = 130) should be referred for further assessment because they might present extreme body dissatisfaction/body dysmorphic disorder symptoms or may be at risk of developing body dysmorphic disorder
Change of eating attitudes and behaviors
Time frame: 16 days
Eating Disorder Inventory-3 (EDI-3; Garner, 2004; Italian version by Giannini et al., 2008): a self-report questionnaire assessing eating disorders core features made up of 91 items on a 6-point Likert scale (from always to never), with higher scores indicating higher eating disorder symptoms. It contains three primary subscales: Drive for Thinness (score range = 0-28; higher scores indicating higher drive for thinness), Bulimia (score range = 0-32; higher scores indicating higher bulimic symptoms), and Body Dissatisfaction (score range = 0-40; higher scores indicating higher body dissatisfaction). These subscales compose the Eating Disorder Risk Composite (EDRC) score. The other nine additional scales are Low Self-Esteem, Personal Alienation, Interpersonal Insecurity, Interpersonal Alienation, Interoceptive Deficits, Emotional Dysregulation, Perfectionism, Asceticism, and Maturity Fears.
2 secondary outcomes
Change of self-esteem
Time frame: 16 days
Change in social anxiety symptoms
Time frame: 16 days
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 19 Nov 2024.
- Individual participant dataSharing planned: Yes
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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 GGBI: Positive Body Image (Mobile App) in people with Body Image Disorder and Body Dysmorphic Disorders, run by University of Padova at 1 site in Italy.
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 3 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 19 Nov 2024. 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 Italy. 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. 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?
Change of body dissatisfaction and body dysmorphic disorder symptoms (time frame: 16 days). The study lists 2 primary outcomes in all. 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 19 Nov 2024.