Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05144906
Other study ID # 493-20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date June 15, 2022

Study information

Verified date November 2021
Source University of Haifa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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: 1. 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. 2. The implicit anti-fat bias effect (IAT D-score) will be comparable between sighted and blind women.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date June 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Blind Women Inclusion Criteria: - 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. Exclusion Criteria: • Any condition that prevents the ability to use a computer. Sighted women Inclusion Criteria: - Aged 18-45 years old. - Corrected or corrected-to-normal vision. - Fluent English speakers. Exclusion Criteria: • Any condition that prevents the ability to use a computer.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Israel University of Haifa Haifa Central

Sponsors (1)

Lead Sponsor Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One assessment at baseline after study information and informed consent was given
Secondary 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. up to 72 hours after completion of the baseline assessment
Secondary 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. up to 72 hours after completion of the baseline assessment
Secondary 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. up to 72 hours after completion of the baseline assessment
Secondary Body mass index (BMI) Weight and height data will be collected via self-report in order to calculate BMI (kg/cm2). up to 72 hours after completion of the baseline assessment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02393118 - A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury N/A
Terminated NCT00262509 - Emergency Egress and Information System for Persons With Vision Loss N/A
Terminated NCT00691444 - Blind Child Melatonin Treatment Study N/A
Recruiting NCT06237829 - Testing Tactile Aids With Blind Subjects N/A
Completed NCT00829036 - Wayfinding Information Access System for People With Vision Loss N/A
Completed NCT02643238 - Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation N/A
Completed NCT01488786 - A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind N/A
Recruiting NCT00403143 - Do Blue-Blocking Lenses Block Blue Colour From Our Lives? N/A
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Recruiting NCT04725760 - Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population N/A
Recruiting NCT02983370 - Development of a Cortical Visual Neuroprosthesis for the Blind N/A
Not yet recruiting NCT06070467 - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
Completed NCT00920231 - Computer Vision System for the Blind Veteran Phase 1
Completed NCT01109576 - Workshops for Veterans With Vision and Hearing Loss Phase 0
Terminated NCT00795236 - Melatonin Studies of Totally Blind Children N/A
Terminated NCT00634972 - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity Phase 4
Enrolling by invitation NCT06364605 - MySpace: the Role of Vision in Representing Space N/A
Terminated NCT03913130 - Extension Study to Study PQ-110-001 (NCT03140969) Phase 1/Phase 2
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed NCT03753893 - Ocular Manifestations in Rheumatic Diseases