- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146792
Expand Your Horizon: An Online Writing Intervention for Women
March 1, 2021 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, participants will be asked to do the following things:
- Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
- ~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.
- Be contacted through email to remind participants to complete the writing assignments/survey
Study Type
Interventional
Enrollment (Actual)
163
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: body acceptance program
|
Complete 3 writing exercises over the course of week.
Each writing exercise will take approximately 15 minutes to complete
|
ACTIVE_COMPARATOR: writing creativity program
|
Complete 3 writing exercises over the course of week.
Each writing exercise will take approximately 15 minutes to complete
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight bias internalization (WBI)
Time Frame: baseline to 2 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body functionality appreciation
Time Frame: baseline to 2 weeks
|
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
|
Change in body image dissatisfaction
Time Frame: Baseline to 2 weeks
|
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
|
Change in objectified body consciousness
Time Frame: Baseline to 2 weeks
|
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
|
Change in self-compassion
Time Frame: Baseline to 2 weeks
|
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
|
Change in depression
Time Frame: Baseline to 2 weeks
|
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
|
Change in anxiety
Time Frame: Baseline to 2 weeks
|
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
|
Change in stress
Time Frame: Baseline to 2 weeks
|
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
|
Change in healthcare stress
Time Frame: Baseline to 2 weeks
|
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
|
Change in healthcare avoidance
Time Frame: Baseline to 2 weeks
|
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
|
Change in physical activity acceptance
Time Frame: Baseline to 2 weeks
|
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
|
Change in global eating disorder symptoms
Time Frame: Baseline to 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 21, 2020
Primary Completion (ACTUAL)
February 25, 2021
Study Completion (ACTUAL)
February 25, 2021
Study Registration Dates
First Submitted
October 29, 2019
First Submitted That Met QC Criteria
October 29, 2019
First Posted (ACTUAL)
October 31, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 2, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HM20016491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual level data will not be shared other researchers.
Access to all data will be limited to study personnel.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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