Body ImageNCT04146792
Expand Your Horizon: An Online Writing Intervention for Women
A study testing body acceptance program and writing creatively program in people with Body Image, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image
- What is being tested?
- body acceptance program and writing creatively program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 25 Feb 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- men
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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
- Conditions
- Body Image
- Being tested
- body acceptance program, writing creatively program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body acceptance programBehavioural
Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
writing creatively programBehavioural
Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
| Study group | Role | What they receive |
|---|---|---|
| body acceptance program | Experimental | Not described Receives: Behavioral: body acceptance program |
| writing creativity program | Active comparator | Not described Receives: Behavioral: writing creatively program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 2 weeks
Secondary outcomes (11)
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.
Measured: baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
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
Measured: Baseline to 2 weeks
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).
Measured: Baseline to 2 weeks
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).
Measured: Baseline to 2 weeks
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).
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
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.
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start21 Feb 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for the Psychological Study of Social Issues
- Responsible party
- Sponsor
- Investigators
- Suzanne Mazzeo, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146792
- Sponsor's protocol ID
- HM20016491
- Status last verified
- Mar 2021
- First submitted
- 29 Oct 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expand Your Horizon: An Online Writing Intervention for Women
- ClinicalTrials.gov ID
- NCT04146792
- Acronym / sponsor ID
- HM20016491
- Conditions
- Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Society for the Psychological Study of Social Issues
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 31 Oct 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| body acceptance program | Experimental | Behavioral: body acceptance program |
| writing creativity program | Active comparator | Behavioral: writing creatively program |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- men
- pregnant women
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 |
|---|---|---|
| body acceptance programComplete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete | Behavioural | body acceptance program |
| writing creatively programComplete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete | Behavioural | writing creativity program |
Primary outcome
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.
11 secondary outcomes
Change in body functionality appreciation
Time frame: baseline to 2 weeks
Change in body image dissatisfaction
Time frame: Baseline to 2 weeks
Change in objectified body consciousness
Time frame: Baseline to 2 weeks
Change in self-compassion
Time frame: Baseline to 2 weeks
Change in depression
Time frame: Baseline to 2 weeks
Change in anxiety
Time frame: Baseline to 2 weeks
Change in stress
Time frame: Baseline to 2 weeks
Change in healthcare stress
Time frame: Baseline to 2 weeks
Change in healthcare avoidance
Time frame: Baseline to 2 weeks
Change in physical activity acceptance
Time frame: Baseline to 2 weeks
Change in global eating disorder symptoms
Time frame: Baseline to 2 weeks
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 2 Mar 2021.
- Individual participant dataSharing planned: No. Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.
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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.
Suzanne Mazzeo, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body acceptance program and writing creatively program in people with Body Image, run by Virginia Commonwealth University at 1 site in United States.
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 3 inclusion and 2 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 2 Mar 2021. 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 United States. 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 in weight bias internalization (WBI) (time frame: baseline to 2 weeks). 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 2 Mar 2021.