BlindnessNCT05144906
Implicit Attitudes Toward Body Shape Among Blind Women
An observational study of Blindness and Implicit Bias, run by University of Haifa at 1 site in Israel.
Trial summary
High levels of body image concerns and disordered eating in western women have been associated with the promotion of an unrealistically thin body ideal. The pressure to conform with the thin-ideal forms both explicit and implicit attitudes favoring thinness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blindness, Implicit Bias
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2021to 15 Jun 2022
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The blind women group will only include women who were blinded earlier than the age of 7 and cannot see themselves in the mirror not recognize other people's faces or bodies or use visual-based media. The sighted women group will include women with normal or corrected-to-normal vision.
Who may be able to join
- Aged 18-45 years.
- Congenitally blind or blinded no later than the age of 7.
- Inability to see themselves in the mirror.
- Inability to recognize other people's faces or bodies.
- Inability to use visual-based media.
- Fluent English speakers.
Show all 9Show fewer
- Aged 18-45 years old.
- Corrected or corrected-to-normal vision.
- Fluent English speakers.
Who cannot join
- Any condition that prevents the ability to use a computer.
- Sighted women
- Any condition that prevents the ability to use a computer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implicit Attitudes Toward Body Shape Among Blind Women: Evidence From an Auditory Implicit Association Test
High levels of body image concerns and disordered eating in western women have been associated with the promotion of an unrealistically thin body ideal. The pressure to conform with the thin-ideal forms both explicit and implicit attitudes favoring thinness. Visual-based media depicting thin-idealized bodies plays a major role in forming such attitudes. However, attitudes favoring thinness can also be transmitted through non-visual communication such as peer pressure and significant others. The current study will examine if implicit attitudes favoring thinness and disliking overweight bodies can be formed without ever being exposed to visual-based media or being visually exposed to body shapes. To achieve this goal, the study will assess implicit attitudes towards thin and overweight bodies in congenitally blind women and those who were blinded early in life. The assessment will be carried out using a novel auditory weight-bias implicit association test.
Read the detailed description
Previous studies have demonstrated strong implicit associations between images portraying thin bodies and positive words and images portraying overweight bodies and negative words among healthy individuals in Western society. This so-called "implicit weight bias" is thought to represent individuals' unconscious or automatic stereotypical attitudes against being overweight. The goal of the current study is to examine implicit weight biases among congenitally blind as well as sighted women using a novel auditory version of the weight bias implicit association task. In this task, participants hear a series of words and are requested to classify each word using a motor response to the matching category. The categories used will be negative and positive words as well as words describing thin and overweight bodies. Implicit anti-fat bias is reflected by longer response times and higher error rates, when positive words and those describing overweight bodies require the same motor response and when negative words are coupled with words describing thin bodies compared to when positive and negative words are coupled with words describing thin and overweight bodies, respectively.
The investigators have collected preliminary results in a sample of blind women (N = 18) in Israel. The investigators plan to a) expand the data collection in Israel to reach a sample of 30 blind women and to b) carry out a full replication of the study in an independent sample of blind and sighted women in the US. Data have not been collected yet for the US replication study. Based on the effect size of the the implicit bias effect (represented by the IAT D score) obtained in preliminary results in the Israeli sample (Cohen's D = 0.74), a power analysis using G*power was carried out and showed that a sample of 22 participants is sufficient to detect the IAT implicit bias effect with a power > 95% and an a-priori alpha set at 0.05.
Based on preliminary results in the Israeli sample, it is hypothesized that:
- Blind women will demonstrate an implicit bias indicating preference for thin bodies and a dislike of overweight bodies. This effect will be reflected by slower response times when words describing thin bodies will be coupled with negative compared to positive words and when words describing overweight bodies will be coupled with positive compared to negative words. This implicit bias effect will be computed using the IAT's D algorithm.
- The implicit anti-fat bias effect (IAT D-score) will be comparable between sighted and blind women.
- Conditions
- Blindness, Implicit Bias
- Medical subject headings
- Blindness, Bias, Implicit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blind women | The blind women group will include women who are congenitally blind or that were blinded early in life (up to the age of 7). | |
| Sighted women | Women with normal or corrected-to-normal eye sight. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implicit Association Test
IAT D-Score calculated for assessing an implicit weight bias. The IAT D score will be computed using the improved algorithm suggested by Greenwald et al. (2003). According to this algorithm, RTs longer than 10,000 ms will be deleted. Participants with more than 10% of the trials that are shorted than 300 ms will be excluded from the analysis. Mean RTs for correct trials will be computed for each block separately. Error trials will be replaced by the mean score of each block + 600 ms. Then, the difference in RTs between the practice stereotype incongruent and practice congruent conditions will be divided by their pooled SD. Then, the different in RTs between the test stereotype congruent and incongruent blocks will be divided by their pooled RTs. Lastly, the two scores form the practice and test blocks will be averaged to compute the IAT D score.
Measured: One assessment at baseline after study information and informed consent was given
Secondary outcomes (4)
Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4R)
The SATAQ-4R is a gender-specific self-report tool composed of 31 items in the female version. It includes four scales to evaluate the perceived pressure from family, peers, significant others, and the media to attain a thin body and three sub-scales that evaluate the desire to attain a lean body, to attain a muscular physique and overall concern with personal appearance. Participants rate their agreement with various statements on a 5-point scale.
Measured: up to 72 hours after completion of the baseline assessment
Ideal Body Stereotype Scale-Revised (IBSS-R)
The IBSS-R measures the pursuit of the thin beauty ideal. Participants are asked to indicate to what extent they agree with six statements about what attractive women look like on a 5-point scale from strongly disagree to strongly agree. The total sum ranges from 0 to 30 with higher scores indicating a stronger internalization of the thin ideal.
Measured: up to 72 hours after completion of the baseline assessment
Body Parts Dissatisfaction Scale (BPDS)
The BPDS assesses body dissatisfaction by asking the respondents to rate their satisfaction with 9 body parts on a scale from 1 (extremely dissatisfied) to 5 (extremely satisfied). Lower scores represent greater body dissatisfaction.
Measured: up to 72 hours after completion of the baseline assessment
Body mass index (BMI)
Weight and height data will be collected via self-report in order to calculate BMI (kg/cm2).
Measured: up to 72 hours after completion of the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noam Weinbach, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144906
- Sponsor's protocol ID
- 493-20
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will provide open access for de-identified data as well as for the analytical plan and protocol.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implicit Attitudes Toward Body Shape Among Blind Women: Evidence From an Auditory Implicit Association Test
- ClinicalTrials.gov ID
- NCT05144906
- Acronym / sponsor ID
- 493-20
- Conditions
- Blindness, Implicit Bias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 3 Dec 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.
High levels of body image concerns and disordered eating in western women have been associated with the promotion of an unrealistically thin body ideal. The pressure to conform with the thin-ideal forms both explicit and implicit attitudes favoring thinness. Visual-based media depicting thin-idealized bodies plays a major role in forming such attitudes. However, attitudes favoring thinness can also be transmitted through non-visual communication such as peer pressure and significant others. The current study will examine if implicit attitudes favoring thinness and disliking overweight bodies can be formed without ever being exposed to visual-based media or being visually exposed to body shapes. To achieve this goal, the study will assess implicit attitudes towards thin and overweight bodies in congenitally blind women and those who were blinded early in life. The assessment will be carried out using a novel auditory weight-bias implicit association test.
Detailed description
Previous studies have demonstrated strong implicit associations between images portraying thin bodies and positive words and images portraying overweight bodies and negative words among healthy individuals in Western society. This so-called "implicit weight bias" is thought to represent individuals' unconscious or automatic stereotypical attitudes against being overweight. The goal of the current study is to examine implicit weight biases among congenitally blind as well as sighted women using a novel auditory version of the weight bias implicit association task. In this task, participants hear a series of words and are requested to classify each word using a motor response to the matching category. The categories used will be negative and positive words as well as words describing thin and overweight bodies. Implicit anti-fat bias is reflected by longer response times and higher error rates, when positive words and those describing overweight bodies require the same motor response and when negative words are coupled with words describing thin bodies compared to when positive and negative words are coupled with words describing thin and overweight bodies, respectively.
The investigators have collected preliminary results in a sample of blind women (N = 18) in Israel. The investigators plan to a) expand the data collection in Israel to reach a sample of 30 blind women and to b) carry out a full replication of the study in an independent sample of blind and sighted women in the US. Data have not been collected yet for the US replication study. Based on the effect size of the the implicit bias effect (represented by the IAT D score) obtained in preliminary results in the Israeli sample (Cohen's D = 0.74), a power analysis using G*power was carried out and showed that a sample of 22 participants is sufficient to detect the IAT implicit bias effect with a power > 95% and an a-priori alpha set at 0.05.
Based on preliminary results in the Israeli sample, it is hypothesized that:
- Blind women will demonstrate an implicit bias indicating preference for thin bodies and a dislike of overweight bodies. This effect will be reflected by slower response times when words describing thin bodies will be coupled with negative compared to positive words and when words describing overweight bodies will be coupled with positive compared to negative words. This implicit bias effect will be computed using the IAT's D algorithm.
- The implicit anti-fat bias effect (IAT D-score) will be comparable between sighted and blind women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind women | – | –The blind women group will include women who are congenitally blind or that were blinded early in life (up to the age of 7). |
| Sighted women | – | –Women with normal or corrected-to-normal eye sight. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The blind women group will only include women who were blinded earlier than the age of 7 and cannot see themselves in the mirror not recognize other people's faces or bodies or use visual-based media. The sighted women group will include women with normal or corrected-to-normal vision.
Key inclusion criteria (9 listed)
- Aged 18-45 years.
- Congenitally blind or blinded no later than the age of 7.
- Inability to see themselves in the mirror.
- Inability to recognize other people's faces or bodies.
- Inability to use visual-based media.
Key exclusion criteria (3 listed)
- Any condition that prevents the ability to use a computer.
- Sighted women
- Any condition that prevents the ability to use a computer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implicit Association Test
Time frame: One assessment at baseline after study information and informed consent was given
IAT D-Score calculated for assessing an implicit weight bias. The IAT D score will be computed using the improved algorithm suggested by Greenwald et al. (2003). According to this algorithm, RTs longer than 10,000 ms will be deleted. Participants with more than 10% of the trials that are shorted than 300 ms will be excluded from the analysis. Mean RTs for correct trials will be computed for each block separately. Error trials will be replaced by the mean score of each block + 600 ms. Then, the difference in RTs between the practice stereotype incongruent and practice congruent conditions will be divided by their pooled SD. Then, the different in RTs between the test stereotype congruent and incongruent blocks will be divided by their pooled RTs. Lastly, the two scores form the practice and test blocks will be averaged to compute the IAT D score.
4 secondary outcomes
Sociocultural Attitudes Toward Appearance Questionnaire-4 (SATAQ-4R)
Time frame: up to 72 hours after completion of the baseline assessment
Ideal Body Stereotype Scale-Revised (IBSS-R)
Time frame: up to 72 hours after completion of the baseline assessment
Body Parts Dissatisfaction Scale (BPDS)
Time frame: up to 72 hours after completion of the baseline assessment
Body mass index (BMI)
Time frame: up to 72 hours after completion of the baseline assessment
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 6 Jul 2022.
- Individual participant dataSharing planned: Yes. The study will provide open access for de-identified data as well as for the analytical plan and protocol.
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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.
Noam Weinbach, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blindness and Implicit Bias, run by University of Haifa at 1 site in Israel.
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 9 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 6 Jul 2022. 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 Israel. 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?
Implicit Association Test (time frame: One assessment at baseline after study information and informed consent was given). 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 6 Jul 2022.