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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146792
Other study ID # HM20016491
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2020
Est. completion date February 25, 2021

Study information

Verified date March 2021
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to test a new writing-based intervention that helps young adult women increase their body acceptance and fosters creativity.


Description:

In this study, participants will be asked to do the following things: 1. Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete 2. ~1-hour long online surveys immediately after the program (1 week), and 1 week after the program. Questions will ask about eating behaviors and attitudes, body image, feelings of weight stigma, and mental health. 3. Be contacted through email to remind participants to complete the writing assignments/survey


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - women ages 18 to 25 years - enrolled in postsecondary education at VCU - endorse some degree of WBI (as measured by the WBI-M) or body image concerns Exclusion Criteria: - men - pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
body acceptance program
Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
writing creatively program
Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Society for the Psychological Study of Social Issues

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in weight bias internalization (WBI) The Modified Weight Bias Internalization Scale (WBIS-M) is a modified version of the Weight Bias Internalization Scale that was adapted for use with individuals across the weight spectrum. The WBIS-M measures the degree to which individuals apply weight-based stereotypes to themselves and use those to guide their weight self-evaluations. Items are rated on a 7-point scale, with higher scores reflecting greater degrees of weight bias internalization. baseline to 2 weeks
Secondary Change in body functionality appreciation Body functionality appreciation will be assessed using the Functionality Appreciation Scale (FAS). The Functionality Appreciation Scale (FAS) is a 7-item scale that measures appreciation for the functionality of one's body, which is believed to help offset appearance concerns. Items are rated on a 5-point scale with higher scores reflecting greater appreciation for the functionality of one's body. baseline to 2 weeks
Secondary Change in body image dissatisfaction Body dissatisfaction will be measured using Body-Image Ideals Questionnaire (BIQ. The BIQ is a 22-item measure that assesses appearance satisfaction. This scale examines both perceived discrepancy between one's body image ideal and current appearance as well as the importance of appearance to one's self-concept. Baseline to 2 weeks
Secondary Change in objectified body consciousness Objectified body consciousness will be assessed using the Body Consciousness Scale (OBCS). This is a 24-item measure that assesses the degree to which one experiences their body as an object. Baseline to 2 weeks
Secondary Change in self-compassion Self-Compassion will be assessed using the Self-Compassion Scale-Short Form (SCS-SF). This is a 12-item measure that assesses the degree to which one is able to hold her or his own feelings of suffering with a sense of warmth, connection, and concern Baseline to 2 weeks
Secondary Change in depression Depression will be assessed using the depression subscale of the Depression, Anxiety, and Stress Scales (DASS-21). This measure asks participants to rate the frequency and severity of negative emotions over the previous week. Items are rated on a four-point scale (0 = did not apply to me at all, 3 = applied to me very much or most of the time). Baseline to 2 weeks
Secondary Change in anxiety Anxiety will be assessed using the anxiety subscale of the Depression, Anxiety, and Stress Scales (DASS-21). This measure asks participants to rate the frequency and severity of negative emotions over the previous week. Items are rated on a four-point scale (0 = did not apply to me at all, 3 = applied to me very much or most of the time). Baseline to 2 weeks
Secondary Change in stress Stress will be assessed using the stress subscale of the Depression, Anxiety, and Stress Scales (DASS-21). This measure asks participants to rate the frequency and severity of negative emotions over the previous week. Items are rated on a four-point scale (0 = did not apply to me at all, 3 = applied to me very much or most of the time). Baseline to 2 weeks
Secondary Change in healthcare stress Healthcare Stress will be assessed using a scale created by weight stigma researchers. This is a five-item scale that was originally adapted for a study on healthcare anxiety in higher weight women. Participants use a 10-point scale (1 = No stress, 10 = Very stressed) to indicate their level of stress when thinking about numerous healthcare encounters. Baseline to 2 weeks
Secondary Change in healthcare avoidance Healthcare Avoidance will be assessed by a four-item scale that measures how often someone avoids healthcare. The measure was adapted for the current study such that we deleted an item about mammograms because it is not relevant to this age group. Also, given the short follow-up period, we assumed that participants' healthcare utilization would not change over the course of the study. Thus, we also modified the rating scale to reflect intent to avoid healthcare. Participants will use a five-point scale (1 = Extremely Likely, 5 = Extremely Unlikely) to indicate their likelihood to utilize numerous healthcare encounters. Baseline to 2 weeks
Secondary Change in physical activity acceptance Physical activity acceptance will be assessed using the Physical Activity Acceptance Questionnaire (PAAQ). The PAAQ is a 10-item measure that assesses participants' ability to accept the discomfort associated with exercising. Baseline to 2 weeks
Secondary Change in global eating disorder symptoms Disordered eating will be assessed using the Eating Disorder Examination - Questionnaire (EDE-Q). The EDE-Q is a 28-item self-report version of the Eating Disorder Examination that measures frequency of disordered eating cognitions and behaviors experienced in the previous 28 days. Participants rate the number of days behaviors have occurred in the last 28 days, with 0 = no days and 6 = every day. Yes/no questions identify the presence of compensatory and binge behaviors and participants indicate the frequency of these behaviors over the last 28 days. Higher EDE-Q scores indicate greater eating pathology. Baseline to 2 weeks
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