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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Physical Activity Incentive Program

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

NCT ID

NCT05519423

First Posted

August 25, 2022

Last Updated

April 11, 2023

Sponsor

Istanbul University - Cerrahpasa (IUC)

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

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

Physical Inactivity, Obesity, Morbid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial