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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
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Obesity, Weight Loss, COVID-19 pandemic

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
March 3, 2022
Last Updated
July 18, 2022
Sponsor
Ankara University
Collaborators
Amasya University
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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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