Reducing Suicide Risk Associated With Weight Loss

Weight Loss Clinical Trial

Official title:

Reducing Suicide Risk Associated With Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541824
• Other study ID #: 10274002
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: March 20, 2017

Study information

• Verified date: May 2018
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Eating Behavior
• Self Harm
• Suicide
• Weight Loss

Intervention

Behavioral:
• Body Acceptance Program
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up	Self-harm frequency and likelihood	Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary	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	Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary	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	Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary	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	Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary	Change from baseline on the Beck Depression Inventory II at follow-up	Depressive symptoms	Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary	Change from baseline on the Body Shape Questionnaire (8-item version #3) at follow-up	Assessment of weight and shape concerns	Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary	Change from baseline on the Positive and Negative Affect Schedule at follow-up	Captures current positive and negative affect	Pre-assessment and post-assessment (after intervention or two weeks from baseline)