Determining the effect of Self-Esteem educational intervention on weight loss in obese patients.
Design
A Randomized Clinical Trial with a control group with a parallel design without blinding was performed on 40 patients who were divided into two groups (20 in each group) via block randomization
Settings and conduct
This was a quasi-experimental study that was performed in 2021 in Farshchian Heart Hospital in Hamadan on obese patients (BMI equal to or greater than 30). Before and at the end of the study (2 months after educational sessions), body mass index was measured and Cooper-Smith self-esteem Inventory (CSEI) was completed for both groups.
Participants/Inclusion and exclusion criteria
The participants who had BMI greater than or equal to 30, aged over 18 years, not being pregnant, and had no history of hypothyroidism, diabetes, cancer or mental disorders such as depression and bulimia nervosa enrolled in the study.
Intervention groups
In the control group, common recommendations such as lifestyle changes, diet, and medication were prescribed if necessary. In the intervention group, in addition to the control group's actions, four consecutive sessions of self-esteem training programs were performed by a psychologist focusing on increasing self-esteem. These educational programs were performed every other week and each session lasts about 2 hours.
Main outcome variables
Weight Loss; Increase Self-Esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220924056026N1
Registration date:2023-02-20, 1401/12/01
Registration timing:retrospective
Last update:2023-02-20, 1401/12/01
Update count:0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Mohamadali Seifrabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0583
Email address
seifrabie@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
2021-06-22, 1400/04/01
Actual recruitment end date
2021-09-06, 1400/06/15
Trial completion date
2022-02-08, 1400/11/19
Scientific title
The effect of Self-Esteem educational intervention on weight loss in obese patients.
Public title
The effect of Self-Esteem educational intervention on weight loss in obese patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Obesity (BMI equel or greater than 30)
Age over 18 years
Exclusion criteria:
Not being pregnant
Had no history of hypothyroidism, diabetes, cancer or mental disorders such as depression and bulimia nervosa
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (4-digit blocks)
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
IR.UMSHA.REC.1398.984
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and Obesity
Primary outcomes
1
Description
Weight
Timepoint
At the beginning and at the end (2 months after starting the intervention)
Method of measurement
Calculating BMI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Conducting an educational intervention including education on self-esteem and ways to increase it in 4 training sessions for 2 months by a psychiatrist.
Category
Behavior
2
Description
Control Group:All routine weight loss programs are similar to the intervention group, including diet, physical activity, etc., without self-esteem training in the intervention group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Preventive Clinic, Farshchian Heart center, Hamadan