Comparing the effect of being in interactive virtual environments and non-interactive virtual environments on the effectiveness of weight loss intervention in overweight and obese people
Comparing the effect of being in interactive virtual environments and non-interactive virtual environments on the effectiveness of weight loss intervention in overweight and obese people
Design
A randomized, controlled clinical trial with 3 parallel groups of 102 individuals
Settings and conduct
In order to evaluate the effect of being in an interactive or non-interactive virtual environment in weight loss interventions, 102 individuals who are attending a dietitian in Ahvaz, will be selected. These individuals will be randomly divided into three groups: a control group and two intervention groups. The control group will receive standard dietary counselling. First intervention group, will receive the standard dietary counselling and also join an interactive group in a social media platform. Members of this group have the opportunity to share their experiences, ask questions and in other words, interact with each other. Second intervention group, will only receive messages about weight loss through social media platform but in a non-interactive way.
Participants/Inclusion and exclusion criteria
Individuals with a BMI of 25 or higher that are able to read and write, use a smartphone and have internet access are included in the study if not pregnant or lactating.
Intervention groups
The participants will be divided into three groups: a control and two intervention groups. In all three groups, diet and nutritional counselling will be provided by the nutritionist. The people in the first intervention group will be involved in an interactive social media group, and people in the second intervention group will receive educational messages through social media in a non-interactive way.
Main outcome variables
weight loss percentage during the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181017041368N1
Registration date:2018-11-14, 1397/08/23
Registration timing:registered_while_recruiting
Last update:2018-11-14, 1397/08/23
Update count:0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
Raziye Tahmasebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 2831
Email address
tahmasebi.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of being in interactive virtual environments and non-interactive virtual environments on the effectiveness of weight loss intervention in overweight and obese people
Public title
using social media for weight loss
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with a BMI of 25 or higher
being able to read and write
having a smartphone
having internet access
age between 18 and 55 years
Exclusion criteria:
pregnant or lactating women
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
By drawing lots, individuals are randomly assigned to one of the three study groups and receive the intervention of the assigned group
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 Ahvaz University of Medical Sciences
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-1579
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
IR.AJUMS.REC.1397.502
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
Primary outcomes
1
Description
weight loss percentage
Timepoint
Weight at baseline and 2 months from the baseline
Method of measurement
Weighing Scale
Secondary outcomes
1
Description
physical activity score
Timepoint
at baseline and 2 months from the baseline
Method of measurement
International Physical Activity Questionnaire
Intervention groups
1
Description
Control group: will receive two sessions of standard diet therapy which includes face-to-face counseling and weight loss diet.
Category
Lifestyle
2
Description
First intervention group: Besides receiving standard diet therapy, they will join a private group in WhatsApp app. Individuals in this group, will receive educational messages aimed at weight loss and also have the opportunity to talk about each subjects and share their experiences. Posting messages in this group will be 1-2 times a week.
Category
Lifestyle
3
Description
Second intervention group: besides receiving standard diet therapy, they will receive educational messages aimed at weight loss through WhatsApp app, on a daily basis.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Nutrition Consultation Clinics and Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-1579
Phone
+98 61 3373 8319
Email
karandish-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Raziye Tahmasebi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3323 2831
Email
tahmasebi.r@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8319
Email
karandish-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Raziye Tahmasebi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 74 3323 2831
Email
tahmasebi.r@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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