Objective: The aim of this study is to compare the efficacy of the combination cognitive group therapy and dietary therapy versus dietary therapy on weight loss and self-efficacy in obese women. Design: A comparative study design with pre and post test, is also semi-experimental method. Setting and conduct: 16 obese women are randomly assigned to a combining cognitive therapy with dietary therapy group (N=8) or dietary therapy group (N=8). Participants including major eligibility criteria: Participants are women with a BMI equal or greater than 30, at least 18 years old and education was at least a diploma. Interventions: Cognitive group therapy is limited to 20 sessions and 2 hours once a week. Dietary intervention also was administrated as usual treatment. Dietary treatment is carried out every two weeks and limits to 8 sessions. Main outcome measure: Weight is measured in both groups of participants at the beginning and after treatment. Self-efficacy: to compare and evaluate self- efficacy, The “Weight Efficacy Life Style Questionnaire” is administrated for both groups at the beginning and after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107317174N1
Registration date:2012-05-28, 1391/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-28, 1391/03/08
Registrant information
Name
Hamid Reza Sasanfar
Name of organization / entity
Kordestan University
Country
Iran (Islamic Republic of)
Phone
+98 21 4481 2510
Email address
hamidreza.sasanfar@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-03-18, 1390/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of combining cognitive group therapy with dietary therapy versus dietary therapy on self-efficacy and weight loss in obese women
Public title
Effectiveness of combining cognitive group therapy with dietary therapy versus dietary therapy on self-efficacy and weight loss in obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: BMI equal to or greater than 30; at least 18 years old, at least a diploma education; do not receive a psychotherapy or other applications that are affective on weight loss or gain.
Exclusion criteria: Pregnant or planning to pregnancy; menopause; receiving psychotropic drugs; addiction; Axis I: Clinical disorders including major depression disorder, psychotics disorder and substance use disorders. Axis II: Personality disorders and intellectual disabilities. Axis III: Acute medical conditions and physical disorders that affect to the obesity treatment. Axis IV: Psychosocial and environmental factors contributing to the obesity treatment.
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Bolvar
City
Tehran
Postal code
Approval date
2012-01-01, 1390/10/11
Ethics committee reference number
40589-14156-14002-90
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Weight
Timepoint
Weight is measured in the beginning and after the treatment.
Method of measurement
Weight is measured by a scale with sensitivity of 100 grams.
2
Description
Self- Efficacy
Timepoint
Self-efficacy is measured at the before and after the treatment.
Method of measurement
weight efficacy life style questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Cognitive group therapy is based on the treatment manual and limited to 20 sessions and 2 hours once a week.
Category
Other
2
Description
Dietary intervention is administrated as usual treatment and carried out every two weeks and limited to 8 sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Minimally Invasive Surgery Research Center
Full name of responsible person
Hamid Reza Sasanfar
Street address
Rasool Akram Hospital, Niaiesh Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
Keshavar blovar, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences