Reducing Suicide Risk Associated With Weight Loss

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Self Harm; Eating Behavior
• Intervention / Treatment: Behavioral: Body Acceptance Program

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Body Acceptance Program; 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.	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.; Other Names: eBody Project
No Intervention: Waitlist control; Participants in the waitlist control group completed baseline and follow-up assessments with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Pamela Keel, Ph.D., Florida State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 20, 2017
• Study Completion (Actual): March 20, 2017

Study Registration Dates

• First Submitted: December 3, 2017
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Body Weight Changes; Weight Loss; Body Weight; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: 10274002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No