Determining the efficacy of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women and its effect on metabolic syndrome components
The efficacy of kg-free protocol group intervention in overweight and obesity
Design
A concealed, randomized, single-blinded controlled clinical trial with a parallel-group design
Settings and conduct
After referring to obesity and the overweight clinic's patients will be assigned to two groups of control and intervention. before intervention, baseline assessment of triglyceride, high-density lipoprotein, fasting blood sugar, blood pressure, BMI, waist circumference and thyroid function tests will be evaluated also, five-factor mindfulness questionnaires, self- criticizing/attacking & self-reassuring scale, self-compassion scale, three-factor eating behavior questionnaire, acceptance and action for related to weight problems questionnaire, the World Health Organization quality of life and sexual function will be evaluated.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Body Mass Index (25≤ BMI)
Lack of severe knee osteoarthritis.
exclusion criteria:
medical illnesses that affect weight such as glandular disease including thyroid problems, diabetes
pregnant and lactating women
medications that change weight and appetite
inability to attend weekly sessions
Severe psychiatric illness
Intervention groups
Intervention group: obese and overweight women with Body Mass Index (25≤ BMI) will receive an acceptance, mindfulness and compassionate-based group intervention and the control group will receive treatment-as-usual (TAU).
Main outcome variables
Triglyceride
HDL
FBS
Blood pressure
BMI
waist circumference
thyroid function
Quality of Life
Sexual Function
Acceptance and Action for Weight-Related Difficulties
Eating Behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190924044866N1
Registration date:2019-10-27, 1398/08/05
Registration timing:registered_while_recruiting
Last update:2019-10-27, 1398/08/05
Update count:1
Registration date
2019-10-27, 1398/08/05
Registrant information
Name
Ali Asgharzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 2712
Email address
ali.asgharzadeh72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the efficacy of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women and its effect on metabolic syndrome components
Public title
Effect of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI (25≤ BMI)
Minimum diploma (to understand the content of the questionnaires and protocols) and
Age range 18-55
Lack of severe knee osteoarthritis (if possible with regular attendance at sessions)
Exclusion criteria:
Medical illnesses affecting weight, such as glandular disease, including thyroid problems, diabetes,
Pregnant women, lactating
Use of drugs that change weight and appetite d)
Impossible to attend weekly sessions
Severe psychiatric illness
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be a block-randomized split method, which is based on randomized block software and a randomization sequence obtained by a colleague who is not involved in the execution process. In which group (intervention or control) each individual is placed in this way, both randomization and hidden allocation are performed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness will be a one-way blind so assessments will be made by someone who has not participated in the intervention and is not aware of the intervention, as most of the outcomes of this study are laboratory indicators. Determine who is in the intervention and control group and will measure waist circumference, weight, and blood pressure by the center staff who do not know the details of the plan.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 1, tehran psychiatric institute
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1398.049
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Triglycerides levels of individuals in test.
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
To evaluate and check-up of triglyceride participants will be introduced to the laboratory.
2
Description
Blood glucose levels of individuals in test.
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
To evaluate and check-up of blood glucose participants will be introduced to the laboratory.
3
Description
High-density lipoprotein (HDL) levels of individuals in test.
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
To evaluate and check-up of High-density lipoprotein (HDL) participants will be introduced to the laboratory.
4
Description
Blood pressure levels of individuals in test.
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
To evaluate and check-up of blood pressure participants will be introduced to the laboratory.
5
Description
Thyroid levels of individuals in test.
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
To evaluate and check-up of thyroid participants will be introduced to the laboratory.
Secondary outcomes
1
Description
Eating
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
Three-Factor Eating Questionnaire
2
Description
Acceptance and Action for Weight-Related Difficulties
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
Acceptance and Action Questionnaire for Weight-Related Difficulties (AAQW)
3
Description
Quality of Life
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
Who Quality of Life-BREF
4
Description
Sexual Function
Timepoint
Per-intervention, mid intervention and post-intervention and follow up
Method of measurement
Female Sexual Function Index-FSFI
Intervention groups
1
Description
Intervention group: Obese and overweight with a body mass index (25 ≤ BMI)- Treatment protocol of acceptance, mindfulness and compassion (Kg-free) by Palmira and et al at the research center of cognitive-behavioral University of Coimbra, Kg-free protocol is designed based on the acceptance, mindfulness and compassion for those who are obese and overweight. This program will be 10 group sessions, weekly, 2 hours plus 2 group booster sessions conducted by a clinical psychologist with the assistance therapist.
Category
Treatment - Other
2
Description
Control group: Treatment as usual for the Control group including, diet and nutrition modification, temporary smoking cessation and physical activity.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Obesity and Overweight Treatment Centers affiliated to Tabriz University of Medical Sciences and Hea
Full name of responsible person
Ali Asgharzade
Street address
Central Building, University Street, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 4212 5220
Email
ali.asgharzadeh72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Asgharzade
Street address
No.1 Tehran psychiatric institute
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 41 4212 5220
Email
ali.asgharzadeh72@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
There is no funding available for this research and the researcher will finance it.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Asgharzade
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
No.1 tehran psychiatric institute
City
Tehran
Province
Tehran
Postal code
5174676800
Phone
+98 41 4212 5220
Email
ali.asgharzadeh72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Asgharzade
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
No 1 Tehran psychiatric institute
City
Tehran
Province
Tehran
Postal code
5174676800
Phone
+98 41 4212 5220
Email
ali.asgharzadeh72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Asgharzade
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Psychology
Street address
No.1 Tehran psychiatric institute
City
Tehran
Province
Tehran
Postal code
5174676800
Phone
+98 41 4212 5220
Email
ali.asgharzadeh72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available