Eating BehaviorNCT03541824
Reducing Suicide Risk Associated With Weight Loss
A study testing Body Acceptance Program in people with Eating Behavior and Self Harm, run by Florida State University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Behavior, Self Harm, Weight Loss
- What is being tested?
- Body Acceptance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 20 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- At least 5 pounds weight suppression
- Engaged in non-suicidal self-injury at least once in past month
Who cannot join
- Indicated being "sure" of suicide attempt on eligibility screener
- Live outside of the United States
- Currently pregnant
About this study
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.
Read the 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.
- Conditions
- Eating Behavior, Self Harm, Weight Loss
- Being tested
- Body Acceptance Program
- Medical subject headings
- Feeding Behavior, Self-Injurious Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Acceptance ProgramBehavioural
Also called eBody Project
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Acceptance Program | Experimental | 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. Receives: Behavioral: Body Acceptance Program |
| Waitlist control | No intervention | Participants in the waitlist control group completed baseline and follow-up assessments with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up
Self-harm frequency and likelihood
Measured: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jul 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Keel, Florida State University
- Investigators
- Pamela Keel, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541824
- Sponsor's protocol ID
- 10274002
- Status last verified
- May 2018
- First submitted
- 3 Dec 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Suicide Risk Associated With Weight Loss
- ClinicalTrials.gov ID
- NCT03541824
- Acronym / sponsor ID
- 10274002
- Conditions
- Eating Behavior, Self Harm, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Acceptance Program | Experimental | Behavioral: Body Acceptance ProgramThe 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. |
| Waitlist control | No intervention | –Participants in the waitlist control group completed baseline and follow-up assessments with no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old
- At least 5 pounds weight suppression
- Engaged in non-suicidal self-injury at least once in past month
Key exclusion criteria (3 listed)
- Indicated being "sure" of suicide attempt on eligibility screener
- Live outside of the United States
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Acceptance ProgramAlso: eBody ProjectThe 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. | Behavioural | Body Acceptance Program |
Primary outcome
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Keel, Ph.D. principal investigator
Florida State University
Questions about this trial
What is this clinical trial studying?
A study testing Body Acceptance Program in people with Eating Behavior and Self Harm, run by Florida State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.