Skip to main content
OpenTrials
Completed

NCT Number: NCT03541824

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eating Behavior Behavior Behavior, Animal Behavioral Symptoms Body Weight Body Weight Changes Feeding Behavior Pathological Conditions, Signs and Symptoms Self Harm Self-Injurious Behavior Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Acceptance Program

Behavioral

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

Primary outcomes

  1. Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Self-harm frequency and likelihood

Secondary outcomes

  1. Change from baseline on the "Body Esteem Scale: Appearance" subscale at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Feelings about one's appearance; scores are summed and range from 0-40, higher scores indicate greater appearance esteem

  2. Change from baseline on the "Body Esteem Scale: Weight" subscale at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Feelings about one's weight; scores are summed and range from 0-32, higher scores indicate greater weight esteem

  3. Change from baseline on the "Body Esteem Scale: Attribution" subscale at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Feelings about one's characteristics; scores are summed and range from 0-20, higher scores indicate greater self-esteem

  4. Change from baseline on the Beck Depression Inventory II at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Depressive symptoms

  5. Change from baseline on the Body Shape Questionnaire (8-item version #3) at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Assessment of weight and shape concerns

  6. Change from baseline on the Positive and Negative Affect Schedule at follow-up

    Time frame: Pre-assessment and post-assessment (after intervention or two weeks from baseline)

    Captures current positive and negative affect

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 31, 2018
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.