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Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals

Primary Purpose

Physical Inactivity, Obesity, Morbid

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical Activity Incentive Program
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physical Inactivity focused on measuring physical activity, morbid obesity, exercise, technology

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals between the ages of 18-60
  • BMI ≥40 kg/m2, morbidly obese awaiting bariatric surgery
  • No surgical operation in the last 6 months

Exclusion Criteria:

  • Having a musculoskeletal disorder or systemic disease that will interfere with physical activity
  • Presence of balance problems that will prevent physical activity
  • Presence of psychiatric or neurological disease affecting cooperation and cognitive functions
  • Presence of acute pain
  • Heartache
  • Having a history of myocardial infarction
  • Presence of conjunctive heart failure
  • Presence of uncontrolled diabetes and hypertension

Sites / Locations

  • Istanbul University-CerrahpaşaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Morbid obesity individuals

Arm Description

All subjects participating in the study will be given physical activity incentive program (PAI) individually. After evaluating it is aimed to provide information transfer and motivation support to increase physical activity levels before bariatric surgery within the scope of PAI. For this purpose, individual face-to-face interviews will conduct with all cases; verbal information will be given about the importance of physical activity, its effects and different levels of severity. The progress of the program will be made with the whats app application. 8-week follow-up chart will be given to the individuals, about the completion of the physical activity follow-up chart prepared in order to raise awareness about the activity levels of individuals in daily life and to increase their physical activity levels. All subjects will record daily step counts, low, moderate, and vigorous activities on the chart at the end of the day, every day for 8 weeks.

Outcomes

Primary Outcome Measures

The International Physical Activity Questionnaires (IPAQ)
The short form of the International Physical Activity Questionnaire (IPAQ) will be used to determine the physical activity levels of the participants. The IPAQ-Short Form is a valid tool used to assess physical activity in young adults. It is a 7-item scale that evaluates the duration and frequency of vigorous physical activity, moderate physical activity, walking and sedentary behavior based on MET values. Physical activity levels are classified into 3 categories according to the scores obtained by multiplying the duration, frequency and MET values of the physical activities that the participants participated in within 7 days and for at least 10 minutes. Accordingly, <600 MET - min/week is defined as inactive, 600 - 3000 MET - min/week low, and >3000 MET - min/week is defined as sufficient physical activity level.

Secondary Outcome Measures

Bioelectrical Impedance Analysis (BIA) Measurement
The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device.
6 Minute Walk Test
According to the guide published by the American Thoracic Society, the 6MWT is easy to administer, better tolerated, and better reflecting daily activities than other walking tests. It can be applied in a short time in a limited space and requires little equipment. 6MWT is used in various disease groups to evaluate functional capacity.
Sit and Stand Test
In order to evaluate the muscular endurance of the subjects, the participant sitting in a 43 cm high standard chair with his arms crossed over his shoulders is asked to stand up and sit down quickly for 30 seconds, and the number of repetitions at which full rise is achieved will be recorded.

Full Information

First Posted
August 25, 2022
Last Updated
April 11, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05519423
Brief Title
Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals
Official Title
Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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
The limited number of studies on the effectiveness of physical activity incentive programs for morbidly obese individuals in the literature shows the need in this area. In this study, primary aim is to investigate the effect of physical activity incentive program applied through face-to-face and whatsapp-based applications on physical activity level, functional capacity and muscular endurance in morbidly obese individuals. Secondary aim is to provide individuals with exercise habits and to ensure participants' sustainability with the physical activity incentive program planned in line with the needs of the individual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Inactivity, Obesity, Morbid
Keywords
physical activity, morbid obesity, exercise, technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morbid obesity individuals
Arm Type
Experimental
Arm Description
All subjects participating in the study will be given physical activity incentive program (PAI) individually. After evaluating it is aimed to provide information transfer and motivation support to increase physical activity levels before bariatric surgery within the scope of PAI. For this purpose, individual face-to-face interviews will conduct with all cases; verbal information will be given about the importance of physical activity, its effects and different levels of severity. The progress of the program will be made with the whats app application. 8-week follow-up chart will be given to the individuals, about the completion of the physical activity follow-up chart prepared in order to raise awareness about the activity levels of individuals in daily life and to increase their physical activity levels. All subjects will record daily step counts, low, moderate, and vigorous activities on the chart at the end of the day, every day for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Incentive Program
Intervention Description
Physical Activity Incentive (PAI) programs, which is a method used in preventive health services, are recommended by a number of public health institutions, including the World Health Organization, thanks to the universal access and high potential of health services. PAI is defined as offering verbal or written advice/guidance to encourage the individual to increase their current level of physical activity.
Primary Outcome Measure Information:
Title
The International Physical Activity Questionnaires (IPAQ)
Description
The short form of the International Physical Activity Questionnaire (IPAQ) will be used to determine the physical activity levels of the participants. The IPAQ-Short Form is a valid tool used to assess physical activity in young adults. It is a 7-item scale that evaluates the duration and frequency of vigorous physical activity, moderate physical activity, walking and sedentary behavior based on MET values. Physical activity levels are classified into 3 categories according to the scores obtained by multiplying the duration, frequency and MET values of the physical activities that the participants participated in within 7 days and for at least 10 minutes. Accordingly, <600 MET - min/week is defined as inactive, 600 - 3000 MET - min/week low, and >3000 MET - min/week is defined as sufficient physical activity level.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Bioelectrical Impedance Analysis (BIA) Measurement
Description
The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device.
Time Frame
up to 8 weeks
Title
6 Minute Walk Test
Description
According to the guide published by the American Thoracic Society, the 6MWT is easy to administer, better tolerated, and better reflecting daily activities than other walking tests. It can be applied in a short time in a limited space and requires little equipment. 6MWT is used in various disease groups to evaluate functional capacity.
Time Frame
up to 8 weeks
Title
Sit and Stand Test
Description
In order to evaluate the muscular endurance of the subjects, the participant sitting in a 43 cm high standard chair with his arms crossed over his shoulders is asked to stand up and sit down quickly for 30 seconds, and the number of repetitions at which full rise is achieved will be recorded.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals between the ages of 18-60 BMI ≥40 kg/m2, morbidly obese awaiting bariatric surgery No surgical operation in the last 6 months Exclusion Criteria: Having a musculoskeletal disorder or systemic disease that will interfere with physical activity Presence of balance problems that will prevent physical activity Presence of psychiatric or neurological disease affecting cooperation and cognitive functions Presence of acute pain Heartache Having a history of myocardial infarction Presence of conjunctive heart failure Presence of uncontrolled diabetes and hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gulfıdan Tokgoz
Phone
02666146911
Email
gulfidan.tokgoz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nilay Arman
Phone
+902128663700
Email
saimenilayarman@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulfıdan Tokgoz
Organizational Affiliation
İstanbul University-Cerrahpasa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nilay Arman
Organizational Affiliation
İstanbul University-Cerrahpasa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hakan Seyit
Organizational Affiliation
BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Karabulut
Organizational Affiliation
BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
İstanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
Citation
Physical Activity Strategy for the WHO European Region 2016-2025; World Health Organisation Regional Office for Europe: Copenhagen, Denmark, 2016; ISBN 9289051477.
Results Reference
background
PubMed Identifier
20545381
Citation
van Poppel MN, Chinapaw MJ, Mokkink LB, van Mechelen W, Terwee CB. Physical activity questionnaires for adults: a systematic review of measurement properties. Sports Med. 2010 Jul 1;40(7):565-600. doi: 10.2165/11531930-000000000-00000.
Results Reference
background
PubMed Identifier
12091180
Citation
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
background
PubMed Identifier
11157613
Citation
Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.
Results Reference
background

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Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals

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