Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000209493
Ethics application status
Approved
Date submitted
22/12/2015
Date registered
16/02/2016
Date last updated
16/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Salivary Cortisol in Women with Binge Eating Disorder
Scientific title
Will salivary cortisol reactivity change in response to visual stimuli in obese and non-obese women with Binge eating disorder?
Secondary ID [1] 287584 0
None
Universal Trial Number (UTN)
U1111-1175-0967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Binge eating disorder 296372 0
Obesity 296373 0
Condition category
Condition code
Diet and Nutrition 296641 296641 0 0
Obesity
Mental Health 296642 296642 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The visual stimuli experimental video will be shown to all subjects, on a single occasion, the experimental video will be 7.5 min of 15 static images of hypercaloric food
Intervention code [1] 292979 0
Other interventions
Comparator / control treatment
The visual stimuli control video will be shown previously to the experimental video to all subjects, on a single ocasion, it will be a 7.5 min video of 15 static images of house appliances. The rest period between the control and the experimental video is one hour.
Control group
Active

Outcomes
Primary outcome [1] 296259 0
Salivary Cortisol with experimental video
Timepoint [1] 296259 0
1st measurement after resting for 30 minutes
2nd measurement immediatly after experimental video.
3rd measurement 15 minutes after experimental video.
4th measurement 60 minutes after experimental video.
Secondary outcome [1] 317998 0
Fat Stigma, meassured by The Stigmatizing situations inventory
Timepoint [1] 317998 0
Baseline
Secondary outcome [2] 317999 0
Depression, it will be determined by having <10 points in Becks Depression Inventory.
Timepoint [2] 317999 0
Baseline

Eligibility
Key inclusion criteria
Women between 18 and 55 years of age with BMI <35kg/m2 with and without binge eating disorder and women between 18 a 55 years of age with BMI >25kg/m2 with and without binge eating disorder.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bipolar disorder, obesive compulsive disorder, schizophrenia, cardiovascular disease, diabetes, cushing syndrome, use of any of these medications: steroids, hormonal contraceptives, antipsychotics, pregnancy, addiction to nicotine, alcohol and/or illegal drugs, menopause, weight loss of 20% or more of body weight.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Does not apply
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Standard deviations and media of all variables (age, weight, BMI, salivary cortisol, depression and fat stigma) will be compared by ANOVA. For differences between baseline cortisol and the three measures after the visual stimuli ANOVA for repeated measures will be used. To estimate correlation between cortisol, BMI, fat stigma and depresion Pearson's R will be used. Regresion models will be used to observe variability in cortisol in response to type of visual stimuli, BMI, and Binge eating disorder. We will use two tailed level of significance of <0.05. We have not found studies that measure the effect size of the visual stimuli, but studies assessing the salivary cortisol levels in women with obesity and with or without BED differences indicate that 20 participants per group would be sufficient to observe changes in salivary cortisol. When the 20 participants per group will be reached statistical power will be calculated and the number of participants to obtain a statistical power of 80%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/12/2015
Actual
Date of last participant enrolment
Anticipated
2/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 7200 0
Mexico
State/province [1] 7200 0

Funding & Sponsors
Funding source category [1] 292596 0
University
Name [1] 292596 0
Universidad Autonoma de Baja California
Country [1] 292596 0
Mexico
Primary sponsor type
University
Name
Universidad Autonoma de Baja California
Address
Calzada Universidad 14418, Parque Industrial Internacional Tijuana. C.P. 22390 Baja California.
Country
Mexico
Secondary sponsor category [1] 291315 0
None
Name [1] 291315 0
NONE
Address [1] 291315 0
NONE
Country [1] 291315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294078 0
Bioethics committee of the Faculty of Medicine and Psychology of the Autonomous University of Baja California
Ethics committee address [1] 294078 0
Calzada Universidad 14418, Parque Industrial Internacional Tijuana. C.P. 22390
Ethics committee country [1] 294078 0
Mexico
Date submitted for ethics approval [1] 294078 0
25/05/2015
Approval date [1] 294078 0
11/06/2015
Ethics approval number [1] 294078 0
D122

Summary
Brief summary
Stress can cause episodes of binging in persons with binge eating disease (BED). People seeking treatment for obesity have 30% higher prevalence of BED. Stress elevates cortisol and persons with BED exposed to stress have exaggerated cortisol reactivity to stress. Elevated cortisol increases food intake and obesity risk. The objective of this controlled clinical trial is to determine salivary cortisol reactivity to visual stimuli in obese women with BED. The S-EDE-Q questionnaire will be used to diagnose BED, fat stigma and depression will be estimated by The Stigmatizing Situations Inventory and The Beck Depression Inventory respectively. Four groups will be stratified by the presence or not of obesity and by the presence or not of BED. All groups will participate in the intervention, a control video (7.5 minutes of neutral imagery) and an experimental video (7.5 minutes of highly caloric food). Salivary cortisol will be measured before, 15 minutes and 60 minutes after each video. We expect to see a higher reactivity of salivary cortisol to visual stimuli, higher levels of depression and fat stigma in subjects with BED.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 675 675 0 0
/AnzctrAttachments/369421-Comite de bioetica Proy. Cortisol Salival en Mujeres.PDF

Contacts
Principal investigator
Name 60742 0
Dr Montserrat Bacardi-Gascon
Address 60742 0
Calzada Universidad 14418, Parque Industrial Internacional Tijuana. C.P. 22390
Country 60742 0
Mexico
Phone 60742 0
+526641938319
Fax 60742 0
Email 60742 0
[email protected]
Contact person for public queries
Name 60743 0
Miss Psyche Calderon-Vargas
Address 60743 0
Calzada Universidad 14418, Parque Industrial Internacional Tijuana. C.P. 22390
Country 60743 0
Mexico
Phone 60743 0
+526646847753
Fax 60743 0
Email 60743 0
[email protected]
Contact person for scientific queries
Name 60744 0
Miss Psyche Calderon-Vargas
Address 60744 0
Calzada Universidad 14418, Parque Industrial Internacional Tijuana. C.P. 22390
Country 60744 0
Mexico
Phone 60744 0
+526646847753
Fax 60744 0
Email 60744 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.