NCT04146792

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

October 29, 2019

Last Update Submit

March 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in body functionality appreciation

    baseline to 2 weeks

  • Change in body image dissatisfaction

    Baseline to 2 weeks

  • Change in objectified body consciousness

    Baseline to 2 weeks

  • Change in self-compassion

    Baseline to 2 weeks

  • Change in depression

    Baseline to 2 weeks

  • +6 more secondary outcomes

Study Arms (2)

body acceptance program

EXPERIMENTAL
Behavioral: body acceptance program

writing creativity program

ACTIVE COMPARATOR
Behavioral: writing creatively program

Interventions

Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete

body acceptance program

Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete

writing creativity program

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • men
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Suzanne Mazzeo, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

February 21, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

March 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Individual level data will not be shared other researchers. Access to all data will be limited to study personnel.

Locations