Reducing Suicide Risk Associated With Weight Loss
Primary Purpose
Eating Behavior, Self Harm, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Body Acceptance Program
Sponsored by
About this trial
This is an interventional treatment trial for Eating Behavior
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years old
- At least 5 pounds weight suppression
- Engaged in non-suicidal self-injury at least once in past month
Exclusion Criteria:
- Indicated being "sure" of suicide attempt on eligibility screener
- Live outside of the United States
- Currently pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Body Acceptance Program
Waitlist control
Arm Description
The Body Acceptance Program (BAP) is the active condition. Participants engage in an online intervention during which they complete online and offline activities designed to challenge the appearance-ideal.
Participants in the waitlist control group completed baseline and follow-up assessments with no intervention.
Outcomes
Primary Outcome Measures
Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up
Self-harm frequency and likelihood
Secondary Outcome Measures
Change from baseline on the "Body Esteem Scale: Appearance" subscale at follow-up
Feelings about one's appearance; scores are summed and range from 0-40, higher scores indicate greater appearance esteem
Change from baseline on the "Body Esteem Scale: Weight" subscale at follow-up
Feelings about one's weight; scores are summed and range from 0-32, higher scores indicate greater weight esteem
Change from baseline on the "Body Esteem Scale: Attribution" subscale at follow-up
Feelings about one's characteristics; scores are summed and range from 0-20, higher scores indicate greater self-esteem
Change from baseline on the Beck Depression Inventory II at follow-up
Depressive symptoms
Change from baseline on the Body Shape Questionnaire (8-item version #3) at follow-up
Assessment of weight and shape concerns
Change from baseline on the Positive and Negative Affect Schedule at follow-up
Captures current positive and negative affect
Full Information
NCT ID
NCT03541824
First Posted
December 3, 2017
Last Updated
May 29, 2018
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT03541824
Brief Title
Reducing Suicide Risk Associated With Weight Loss
Official Title
Reducing Suicide Risk Associated With Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the efficacy of an intervention aimed at promoting a healthy lifestyle and reducing risk factors associated with eating pathology, nonsuicidal self-injury, and suicidal behavior. We are also interested in assessing whether this intervention has the potential to prevent future symptoms of eating problems and self-harm urges and behaviors. The broader goal of this research is to identify factors that may help us better understand the prevention of self-harm behaviors and develop more effective treatments for these problems.
Detailed Description
The current study was designed as a proof-of-concept study to test the association between weight suppression (WS; difference between one's highest and lowest weight) and non-suicidal self-injury (NSSI). Previous research has found an association between current WS and lifetime NSSI and that this association was mediated by depressive symptoms and drive for thinness. The current study therefore modified an existing online cognitive dissonance-based program (the e-Body Project) using mixed gender content (from the Body Project 4 All scripts) to target posited mediators, i.e., depressive symptoms and weight and shape concerns, in a sample of individuals with WS and engagement in current NSSI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Behavior, Self Harm, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Acceptance Program
Arm Type
Experimental
Arm Description
The Body Acceptance Program (BAP) is the active condition. Participants engage in an online intervention during which they complete online and offline activities designed to challenge the appearance-ideal.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group completed baseline and follow-up assessments with no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Body Acceptance Program
Other Intervention Name(s)
eBody Project
Intervention Description
The Body Acceptance Program is a mixed-gender modification of the eBody Project, an online intervention in which cognitive dissonance principals are used to reduce eating pathology.
Primary Outcome Measure Information:
Title
Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up
Description
Self-harm frequency and likelihood
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary Outcome Measure Information:
Title
Change from baseline on the "Body Esteem Scale: Appearance" subscale at follow-up
Description
Feelings about one's appearance; scores are summed and range from 0-40, higher scores indicate greater appearance esteem
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Title
Change from baseline on the "Body Esteem Scale: Weight" subscale at follow-up
Description
Feelings about one's weight; scores are summed and range from 0-32, higher scores indicate greater weight esteem
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Title
Change from baseline on the "Body Esteem Scale: Attribution" subscale at follow-up
Description
Feelings about one's characteristics; scores are summed and range from 0-20, higher scores indicate greater self-esteem
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Title
Change from baseline on the Beck Depression Inventory II at follow-up
Description
Depressive symptoms
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Title
Change from baseline on the Body Shape Questionnaire (8-item version #3) at follow-up
Description
Assessment of weight and shape concerns
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Title
Change from baseline on the Positive and Negative Affect Schedule at follow-up
Description
Captures current positive and negative affect
Time Frame
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years old
At least 5 pounds weight suppression
Engaged in non-suicidal self-injury at least once in past month
Exclusion Criteria:
Indicated being "sure" of suicide attempt on eligibility screener
Live outside of the United States
Currently pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Keel, Ph.D.
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants' responses to measures collected during the study will be shared with the funding body, the Military Suicide Research Consortium, as part of their Core Data Elements project, a centralized database of data from all MSRC funded projects. All participant responses are deidentified and are uploaded to the MSRC through a secure upload.
IPD Sharing Time Frame
Study protocol and informed consent forms will be shared during and after study recruitment. Participants' responses to measures collected during the study will be shared at the end of participant completion.
IPD Sharing Access Criteria
Once data is uploaded to the Core Data Element (CDE) project, it may be combined with data from other projects for greater power to conduct statistical analyses, including, but not limited to, regression analyses and scale development. The following link (https://msrc.fsu.edu/members/request-access-msrc-database) describes steps that investigators must take in order to access the data. In addition, the study protocols and consent forms are reviewed and approved by the Department of Defense Human Research Protection Office (HRPO) throughout the study.
Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
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Reducing Suicide Risk Associated With Weight Loss
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