Physical InactivityNCT05519423
Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals
A study testing Physical Activity Incentive Program in people with Physical Inactivity and Obesity, Morbid, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Obesity, Morbid
- What is being tested?
- Physical Activity Incentive Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between the ages of 18-60
- BMI ≥40 kg/m2, morbidly obese awaiting bariatric surgery
- No surgical operation in the last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Physical Inactivity, Obesity, Morbid
- Being tested
- Physical Activity Incentive Program
- Keywords
- physical activity, morbid obesity, exercise, technology
- Medical subject headings
- Sedentary Behavior, Obesity, Morbid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Incentive ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Morbid obesity individuals | Experimental | 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. Receives: Behavioral: Physical Activity Incentive Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 weeks
Secondary outcomes (3)
Bioelectrical Impedance Analysis (BIA) Measurement
The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulfidan Tokgoz, Istanbul University - Cerrahpasa
- Investigators
- Gulfıdan Tokgoz, Principal investigator, İstanbul University-CerrahpasaNilay Arman, Principal investigator, İstanbul University-CerrahpasaHakan Seyit, Principal investigator, BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITALMehmet Karabulut, Principal investigator, BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519423
- Sponsor's protocol ID
- 2022/241
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Physical Activity Strategy for the WHO European Region 2016-2025; World Health Organisation Regional Office for Europe: Copenhagen, Denmark, 2016; ISBN 9289051477.
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.
PubMed 20545381ATS 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.
PubMed 12091180Solway 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.
PubMed 11157613
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals
- ClinicalTrials.gov ID
- NCT05519423
- Acronym / sponsor ID
- 2022/241
- Conditions
- Physical Inactivity, Obesity, Morbid
- Keywords
- physical activity, morbid obesity, exercise, technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbid obesity individuals | Experimental | Behavioral: Physical Activity Incentive ProgramAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals between the ages of 18-60
- BMI ≥40 kg/m2, morbidly obese awaiting bariatric surgery
- No surgical operation in the last 6 months
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Incentive ProgramPhysical 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. | Behavioural | Morbid obesity individuals |
Primary outcome
The International Physical Activity Questionnaires (IPAQ)
Time frame: up to 8 weeks
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.
3 secondary outcomes
Bioelectrical Impedance Analysis (BIA) Measurement
Time frame: up to 8 weeks
6 Minute Walk Test
Time frame: up to 8 weeks
Sit and Stand Test
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- BackgroundPhysical Activity Strategy for the WHO European Region 2016-2025; World Health Organisation Regional Office for Europe: Copenhagen, Denmark, 2016; ISBN 9289051477.
- Background: PubMed 20545381van 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.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 11157613Solway 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulfıdan Tokgoz principal investigator
İstanbul University-Cerrahpasa
Nilay Arman principal investigator
İstanbul University-Cerrahpasa
Hakan Seyit principal investigator
BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Incentive Program in people with Physical Inactivity and Obesity, Morbid, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Physical Activity Questionnaires (IPAQ) (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519423, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.