NCT05428059

Brief Summary

Obesity, which is the second leading cause of preventable death in the world, affects all the systems in the body and affects many physiological problems, as well as the mental state, body image and quality of life of the individual. For this reason, obese individuals try various treatment methods in order to get rid of obesity, and in cases where these methods fail, they often prefer bariatric surgery. It is very important that patients who will undergo bariatric surgery can adapt to the anatomical changes in their body and shape their lifestyle accordingly. Otherwise, it is inevitable for patients to face various complications after surgery. After bariatric surgery, a structured training program in the preoperative period is of great importance in order for the patient to adapt to the changes in his body, to prevent the development of possible complications, to be affected by the negativities that may occur due to the current change, and to prepare for the new lifestyle. In this context, the main subject of this research is to enable individuals to gain healthy lifestyle behaviors by providing mobile-based training and consultancy services that enable them to easily access the right information at the desired time and place.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

June 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

June 15, 2022

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Effect of Mobile Health-Education Application on Healthy Lifestyle Behaviors in Patients Planned for Bariatric Surgery

    Data will be evaluated using the Healthy Lifestyle Behaviors Scale-II. The minimum score that can be obtained from the 52-item scale is 52, and the maximum score is 208. A high score from the scale indicates that individuals have good HLPS levels, and low scores indicate bad HLBD.

    one months

Study Arms (2)

application group

EXPERIMENTAL

In addition to standard care, training and consultancy will be provided with a mobile application.

Other: mobile education

control group

NO INTERVENTION

Standard care will be given

Interventions

The training content prepared by the researchers will be presented to the expert opinion. After the necessary arrangements, it will be installed on the mobile application. The mobile application will be downloaded to the patients' phones for one month. It will be in live consultation.

application group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being literate,
  • Being able to understand, speak Turkish and not have a hearing impairment,
  • First time to undergo bariatric surgery,
  • Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
  • Ability to use Android-based smartphones,
  • Agreeing to participate in the research.

You may not qualify if:

  • Patient's desire to quit the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University Institute of Health Sciences

Adana, 01030, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer Dr.

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 22, 2022

Study Start

August 1, 2022

Primary Completion

December 30, 2023

Study Completion

July 1, 2025

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations