NCT05519423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

August 25, 2022

Last Update Submit

March 5, 2024

Conditions

Physical InactivityObesity, Morbid

Keywords

physical activitymorbid obesityexercisetechnology

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 8 weeks

Secondary Outcomes (3)

  • Bioelectrical Impedance Analysis (BIA) Measurement

    up to 8 weeks

  • 6 Minute Walk Test

    up to 8 weeks

  • Sit and Stand Test

    up to 8 weeks

Study Arms (1)

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.

Behavioral: Physical Activity Incentive Program

Interventions

Physical Activity Incentive ProgramBEHAVIORAL

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.

Morbid obesity individuals

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Physical Activity Strategy for the WHO European Region 2016-2025; World Health Organisation Regional Office for Europe: Copenhagen, Denmark, 2016; ISBN 9289051477.

    BACKGROUND

  • 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.

    PMID: 20545381BACKGROUND

  • 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.

    PMID: 12091180BACKGROUND

  • 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.

    PMID: 11157613BACKGROUND

MeSH Terms

Conditions

Sedentary BehaviorObesity, MorbidMotor Activity

Condition Hierarchy (Ancestors)

BehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulfıdan Tokgoz

    İstanbul University-Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Nilay Arman

    İstanbul University-Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Hakan Seyit

    BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

  • Mehmet Karabulut

    BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PT

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

December 1, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

TU(1)