The Effect of Telephone and Video Counseling on Weight Loss and Quality of Life
Primary Purpose
Weight Loss, Obesity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Obesity, Weight Loss, COVID-19 pandemic
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 20-65
- Being obese (BMI≥30 kg/m2)
- Having a smartphone with internet access and being competent to use it
- Volunteering to participate in research
Exclusion Criteria:
- Being pregnant/lactating
- Having a hearing problem
- Being on a followed diet program
Sites / Locations
- Ümüş Özbey
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
phone counseling
video counseling
Traditional follow up
Arm Description
dietary intervention via phone counseling
dietary intervention via video counseling
dietary intervention via traditional follow up
Outcomes
Primary Outcome Measures
Weight chance
BMI (kilogram/ metre2 (kg/m2))
Secondary Outcome Measures
Quality of Life Score
The score ranges from 0 to 100 points, with an increased score reflecting improved quality of life
Full Information
NCT ID
NCT05276544
First Posted
March 3, 2022
Last Updated
July 18, 2022
Sponsor
Ankara University
Collaborators
Amasya University
1. Study Identification
Unique Protocol Identification Number
NCT05276544
Brief Title
The Effect of Telephone and Video Counseling on Weight Loss and Quality of Life
Official Title
The Effect of Telephone and Video Counseling Given to Obese Individuals on Weight Loss and Quality of Life in the COVID-19 Pandemic: an RCT
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
Collaborators
Amasya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread during the COVID-19 pandemic resulted in major changes to daily routines . Several studies have demonstrated that individuals with overweight/obesity reported worsening mental health, poor eating habits , less physical activity (PA) since the onset of the COVID-19 pandemic. Because of these pandemic rules, the use of phone/video consultancy applications and online classes for body weight control and diet monitoring is increasing. Therefore, in this study it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.
Detailed Description
The use of phone/video consultancy applications for body weight control and diet monitoring is increasing. One of the main reasons for this situation is that individuals care more about the social distance rule as a result of the increase in health concerns after the COVID-19 (SARS-CoV-2) pandemic. In addition, due to the uncertainty of how long the pandemic will last, many people are adapting to online applications and programs quicly. However, it's unclear which method of phone/video-based diet counseling is more successful or preferable to traditional diet follow-up. Based on the above-mentioned information; in this study, it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.
Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 3 groups: telephone counseling (15), video counseling (15) and traditional follow-up group (Figure 1.). Food consumption records, anthropometric measurements and quality of life scale scores of all individuals will record at the beginning and end of the study (Figure 2.). In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity
Keywords
Obesity, Weight Loss, COVID-19 pandemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phone counseling
Arm Type
Experimental
Arm Description
dietary intervention via phone counseling
Arm Title
video counseling
Arm Type
Experimental
Arm Description
dietary intervention via video counseling
Arm Title
Traditional follow up
Arm Type
Experimental
Arm Description
dietary intervention via traditional follow up
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Intervention Description
Dietary intervention: Preparation and follow-up of diet program.
Primary Outcome Measure Information:
Title
Weight chance
Description
BMI (kilogram/ metre2 (kg/m2))
Time Frame
At the end of the 3 months
Secondary Outcome Measure Information:
Title
Quality of Life Score
Description
The score ranges from 0 to 100 points, with an increased score reflecting improved quality of life
Time Frame
At the end of the 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 20-65
Being obese (BMI≥30 kg/m2)
Having a smartphone with internet access and being competent to use it
Volunteering to participate in research
Exclusion Criteria:
Being pregnant/lactating
Having a hearing problem
Being on a followed diet program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ümüş Ö yücel, Dr
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ümüş Özbey
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Telephone and Video Counseling on Weight Loss and Quality of Life
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