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Reduction of Emotional Eating After a Behavior Change Program in Obesity

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ClinicalTrials.gov Identifier: NCT01997697
Recruitment Status : Unknown
Verified December 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Recent studies show that overweight people have a greater sensitivity to the rewarding aspect of food due to the disturbance of the dopaminergic system. These perturbations lead to a greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to food would also facilitate food intake related to emotions, whether they are positive or negative. However, the food intake in response to emotions can be modulated by physical activity. But, there are no interventional studies in the literature examining the behavioral and biological factors related to emotional eating together with the fact, there are few data on the explanatory mechanisms. The purpose of the study is to evaluate the predictive factors of emotional eating 6 months after a behavior change program adapted to the motivational state and to identify the its underlying mechanisms

Condition or disease Intervention/treatment Phase
Obesity Other: behavior change program Not Applicable

Detailed Description:

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

    1. Identification of predictive factors Student T test to select the predictive factors
    2. Predictive factors Multiple linear regression
    3. Mechanisms analysis of mediation with the Baron and Kenny method

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Predictive Factors of the Reduction of Emotional Eating After a Behavior Change Program Among Individuals With Obesity of Class II and Class III.
Study Start Date : November 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Patients with obesity
behavior change program among patients with obesity
Other: behavior change program
behavior change program among patients with obesity




Primary Outcome Measures :
  1. Emotional eating assessed by the Dutch Eating behavior questionnaire [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997697


Contacts
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Contact: Ariane Sultan, MCU-PH a-sultant@chu-montpellier.fr
Contact: Ahmed Romain, CRA a-romain@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier-Hopital La colombière Recruiting
Montpellier, France, 34295
Contact: Ahmed Romain, CRA       a-romain@chu-montpellier.fr   
Principal Investigator: Ariane Sultan, MCU-PH         
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01997697     History of Changes
Other Study ID Numbers: UF 9110
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms