- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01997697
Reduction of Emotional Eating After a Behavior Change Program in Obesity
Predictive Factors of the Reduction of Emotional Eating After a Behavior Change Program Among Individuals With Obesity of Class II and Class III.
Panoramica dello studio
Descrizione dettagliata
While emotional eating, food intake in response to emotions, can be modulated by physical activity, the practice of that latter is difficult mostly in people with overweight. Thus, there is a need to adapt the practice of physical activity in function of the motivation of the individual. One of most prominent theoretical model is the transtheoretical model. Regarding changes in physical activity and eating behavior, some data suggest that the processes of change from the transtheoretical model predict the efficacy of a treatment and thus its therapeutic success. The motivational approach could lead to self-regulation of emotions and therefore a decrease in emotional eating. Methods The study is a prospective cohort. Participants are exposed to a five-days hospitalization and engaged in a program of therapeutic education. During this hospitalization, there are some collective and individuals workshop on topics related to physical activity and nutrition. Intervention The intervention is based on the processes of change from the transtheoretical model. There are 5 experiential and 5 behavioral processes of change. Thus, according to the response of a questionnaire evaluating these processes of change, participants will be proposed some individualized strategies. Types of intervention Depending on scores of motivation, the following strategies will be proposed to participants.
- identify the barriers related to physical activity
- increase informations related to physical activity and nutrition
- informations about the risk related to inactivity and diet
- ask to the individual to list and barriers related to barriers as thhe interest to modify the behavior.
- List persons who may act as social support
- set behavior change goals
- Increase self-confidence and self-efficacy about changing behavior
- Relaxation at home
- Use reinforcement management
- methods of time management
- counter-conditioning
identify factors related to the relapse Time management Participants will be evaluated after the first 6 months. Then, they will be followed during 24 months. Statistical analysis Sample size The sample was calculated using a previous study. To obtain a difference of 0.51 in emotional eating with a standard deviation of 1.63 with an alpha risk of 5% and a power of 90%, the number of subject is 110 subject. Expected a drop-out of 20%, 138 subjects will be included. Predictive factors
- Identification of predictive factors Student T test to select the predictive factors
- Predictive factors Multiple linear regression
- Mechanisms analysis of mediation with the Baron and Kenny method
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Montpellier, Francia, 34295
- University Hospital of Montpellier-Hopital La colombière
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with obesity (grade 2 or 3)
- Age 18 to 65
- participation to the therapeutic training
- Patient with non physical activity
Exclusion Criteria:
- Patients needing chirurgigical act
- patient taking neuroleptic or psychiatric
- pregnancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Patients with obesity
behavior change program among patients with obesity
|
behavior change program among patients with obesity
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Emotional eating assessed by the Dutch Eating behavior questionnaire
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 9110
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su behavior change program
-
Allurion TechnologiesCompletato
-
Chang Gung Memorial HospitalIscrizione su invito
-
Children's Hospital Medical Center, CincinnatiAttivo, non reclutante
-
University of ManitobaCanadian Institutes of Health Research (CIHR)ReclutamentoViolenza, domesticaCanada
-
Chang Gung Memorial HospitalIscrizione su invito
-
Inner Mongolia Yili Industrial Group Co., LtdCompletatoDispepsia | Dolore addominale | Stipsi | FlatulenzaCina
-
Leiden University Medical CenterUMC UtrechtIscrizione su invito
-
Chang Gung Memorial HospitalCompletatoFibrillazione atrialeTaiwan
-
Chang Gung Memorial HospitalCompletatoDisfunzione sistolica ventricolare sinistraTaiwan
-
Universidad de SonoraCentro de Investigación en Alimentación y Desarrollo A.C.; Instituto Nacional...Non ancora reclutamentoPrevenzione dell'obesità infantile