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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
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 3, 2017
    Last Updated
    May 29, 2018
    Sponsor
    Florida State University
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    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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