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

Detailed 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

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.

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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