NCT05278767

Brief Summary

This study was conducted as a randomized controlled trial to determine the effects of e-mobile education and counselling service on self-care agency, body image, and quality of life in patients undergoing bariatric surgery. The sample of the study was determined using power analysis after making preliminary tests with the patients who met the sample selection criteria in Isparta City Hospital Obesity Center, and consisted of 51 (26 experiment, 25 control) patients. The patients in the experimental group received e-mobile training and consultancy services with the mobile application developed specifically for bariatric surgery that started before the operation and lasted for 3 months. The data of the study were collected using the Personal Information Form, Self-Care Agency, Body Image, and Moorehead Ardelt Quality of Life II (MA-II) Scales prepared in accordance with the literature. In addition to descriptive statistics, Chi-Square, Independent Samples t-test, Repeated Measures, Mann-Whitney U and Friedman tests were used to evaluate the data. A statistically significant difference was found in the mean scores of Self-Care Strength, Body Image, MA-II and BMI of the patients in the experimental and control groups according to the processes (p\>0.05). There was no statistically significant difference between the groups in terms of preoperative, 1st, 2nd, and 3rd month Self-Care Power, Body Image and MA-II scale mean scores (p\>0.05). There was a statistically significant difference between the groups in favour of the experimental group in terms of the 1st, 2nd, and 3rd month BMI averages (p\<0.05).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

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

Study Start

First participant enrolled

February 25, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

January 10, 2022

Last Update Submit

March 3, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Self Care Agency and E-Mobile Training and Consultancy

    One of the main aims of this researchis to evaluate self-care agency satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the self-care agency scale was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.

    Three months

  • Body Image and E-Mobile Training and Consultancy

    One of the main aims of this researchis to evaluate body image satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the body image scale was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.

    Three months

  • Quality of Life and E-Mobile Training and Consultancy

    One of the main aims of this researchis to evaluate quality of life satisfaction of the individuals by providing mobile-based training and consultancy services that enable them to easily access the right information at any time and place. In this context, the Moorehead-Ardelt Quality of Life Questionnaire II was used. For this, individuals were evaluated before the operation, at the 1st, 2nd, and 3rd months after the operation.

    Three months

Study Arms (2)

application group

EXPERIMENTAL

The mobile health application (https://play.google.com/store/apps/details?id=com.sanberk.bariatriksurgery) prepared for patients undergoing bariatric surgery was completed in 6 stages. After the mobile application has been developed, a short (20-minute) brief contains information about the mobile application in the pre-operative polyclinic for the patients who are planned for bariatric surgery. The patient was followed for three months. Data were collected from the patient every month (4 times).

Other: E-Mobile Education and Counselling

control group

NO INTERVENTION

Standard care and follow-up protocols were applied to the patients.The patient was followed for three months. Data were collected from the patient every month (4 times).

Interventions

The patients in the experimental group received e-mobile training and consultancy services with the mobile application developed specifically for bariatric surgery that started before the operation and lasted for 3 months.

application group

Eligibility Criteria

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

You may qualify if:

  • Being literate,
  • Being able to understand and speak Turkish
  • First time bariatric surgery,
  • Having undergone sleeve gastrectomy or gastric bypass operation with laparoscopic method,
  • Ability to use a smart phone,

You may not qualify if:

  • Having any psychiatric disorder that will reduce the ability to comprehend and understand,
  • Any complications during the surgical intervention,
  • Having a speech and hearing disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University Institute of Health Sciences

Adana, 01030, Turkey (Türkiye)

Location

Related Publications (1)

  • Deniz Dogan S, Arslan S. The Effects of e-Mobile Training and Consultancy Services on Bariatric Surgery Patients: A Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3650-3657. doi: 10.1007/s11695-022-06255-x. Epub 2022 Sep 1.

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

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

Study Record Dates

First Submitted

January 10, 2022

First Posted

March 14, 2022

Study Start

February 25, 2020

Primary Completion

July 25, 2021

Study Completion

January 10, 2022

Last Updated

March 14, 2022

Record last verified: 2022-03

Locations