- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03541824
Reducing Suicide Risk Associated With Weight Loss
29 mai 2018 mis à jour par: Pamela Keel, Florida State University
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
59
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
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.
Autres noms:
|
Aucune intervention: Waitlist control
Participants in the waitlist control group completed baseline and follow-up assessments with no intervention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up
Délai: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Self-harm frequency and likelihood
|
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline on the "Body Esteem Scale: Appearance" subscale at follow-up
Délai: 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
|
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
Délai: 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
|
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
Délai: 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
|
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Change from baseline on the Beck Depression Inventory II at follow-up
Délai: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
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
Délai: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
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
Délai: Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Captures current positive and negative affect
|
Pre-assessment and post-assessment (after intervention or two weeks from baseline)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Pamela Keel, Ph.D., Florida State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2016
Achèvement primaire (Réel)
20 mars 2017
Achèvement de l'étude (Réel)
20 mars 2017
Dates d'inscription aux études
Première soumission
3 décembre 2017
Première soumission répondant aux critères de contrôle qualité
29 mai 2018
Première publication (Réel)
31 mai 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 mai 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10274002
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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