Reduction of Emotional Eating After a Behavior Change Program in Obesity
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
behavior change program
Sponsored by

About this trial
This is an interventional basic science trial for Obesity
Eligibility 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
Sites / Locations
- University Hospital of Montpellier-Hopital La colombière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with obesity
Arm Description
behavior change program among patients with obesity
Outcomes
Primary Outcome Measures
Emotional eating assessed by the Dutch Eating behavior questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT01997697
First Posted
November 21, 2013
Last Updated
December 7, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01997697
Brief Title
Reduction of Emotional Eating After a Behavior Change Program in Obesity
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 Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 22, 2013 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
November 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with obesity
Arm Type
Experimental
Arm Description
behavior change program among patients with obesity
Intervention Type
Other
Intervention Name(s)
behavior change program
Intervention Description
behavior change program among patients with obesity
Primary Outcome Measure Information:
Title
Emotional eating assessed by the Dutch Eating behavior questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital of Montpellier-Hopital La colombière
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Reduction of Emotional Eating After a Behavior Change Program in Obesity
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