Protocol summary
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Study aim
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The efficacy of kg-free protocol group intervention in overweight and obesity
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Design
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A concealed, randomized, single-blinded controlled clinical trial with a parallel-group design
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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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
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Reason for update
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Edit age and Inclusion criterion
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190924044866N1
Registration date:
2019-10-27, 1398/08/05
Registration timing:
registered_while_recruiting
Last update:
2019-10-29, 1398/08/07
Update count:
1
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Registration date
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2019-10-27, 1398/08/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-22, 1398/07/30
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Expected recruitment end date
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2019-11-21, 1398/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Determining the efficacy of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women and its effect on metabolic syndrome components
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Public title
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Effect of an acceptance, mindfulness and compassionate-based group intervention in overweight and obese women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
BMI (25≤ BMI)
Reading and writing literacy
Age range 40-65
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
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Age
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From 40 years old to 65 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
51
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-24, 1397/12/05
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Ethics committee reference number
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IR.IUMS.REC.1398.049
Health conditions studied
1
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Description of health condition studied
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Obesity and overweight
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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Triglycerides levels of individuals in test.
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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To evaluate and check-up of triglyceride participants will be introduced to the laboratory.
2
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Description
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Blood glucose levels of individuals in test.
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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To evaluate and check-up of blood glucose participants will be introduced to the laboratory.
3
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Description
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High-density lipoprotein (HDL) levels of individuals in test.
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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To evaluate and check-up of High-density lipoprotein (HDL) participants will be introduced to the laboratory.
4
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Description
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Blood pressure levels of individuals in test.
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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To evaluate and check-up of blood pressure participants will be introduced to the laboratory.
5
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Description
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Thyroid levels of individuals in test.
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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To evaluate and check-up of thyroid participants will be introduced to the laboratory.
Secondary outcomes
1
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Description
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Eating
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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Three-Factor Eating Questionnaire
2
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Description
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Acceptance and Action for Weight-Related Difficulties
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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Acceptance and Action Questionnaire for Weight-Related Difficulties (AAQW)
3
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Description
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Quality of Life
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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Who Quality of Life-BREF
4
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Description
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Sexual Function
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Timepoint
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Per-intervention, mid intervention and post-intervention and follow up
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Method of measurement
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Female Sexual Function Index-FSFI
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: Treatment as usual for the Control group including, diet and nutrition modification, temporary smoking cessation and physical activity.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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There is no funding available for this research and the researcher will finance it.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available