Weight Regain After Bariatric Surgery and Web-Based Interactive Nurse Support Program: Mixed Methods Research

May 24, 2022 updated by: Ezgi Yildiz, Cumhuriyet University

The Effect of Web-Based Interactive Nurse Support Program Based on Health Promotion Model on Healthy Living Behaviors and Self-Efficacy in Individuals Who Gain Weight After Bariatric Surgery: A Mixed Method Study

This study was planned to determine the effect of the web-based interactive nurse support program developed in line with the Health Promotion Model on healthy living behaviors and self-efficacy in individuals who gain weight after bariatric surgery. Mixed method is a research. The exploratory sequential design, one of the mixed research methods, will be used. The research will continue with the quantitative part starting with the qualitative part. The quantitative part of the research is a randomized controlled experimental study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was planned to determine the effect of the web-based interactive nurse support program developed in line with the Health Promotion Model on healthy living behaviors and self-efficacy in individuals who gain weight after bariatric surgery. Mixed method is a research. In the qualitative part of the study, factors that prevent individuals from developing health behaviors will be determined. In the quantitative part of the study, a web-based training program will be prepared in order to reduce the perception of disability in individuals towards health-enhancing behavior, to adopt a healthy behavior style and to increase their self-efficacy. The universe of the study will be individuals who had bariatric surgery in the general surgery service between 2015-2019 in a university hospital in Turkey and gained weight again. Qualitative interviews will be held face to face with the video method over the "Zoom" application. "Criterion sampling method", one of the purposeful sampling methods used in qualitative research, will be used. In the qualitative part of the research, the individual in-depth interview method will be selected, and the "Semi-Structured Interview Form" will be used as the data collection tool. Interviews with individuals will continue until data saturation is reached. All interviews will be recorded in digital format, transcribed and subsequently imported into the qualitative analysis software MAXQDA. The quantitative part of the research is a randomized controlled experimental study. Randomization will be done by a statistician other than the researcher. Power analysis was calculated using G * Power 3.1.9.7 program. With 80% effect size, 90% power and 0.05 significance level, the required sample size was determined as 28 individuals per group, and 56 individuals in total. It was decided to include 62 individuals, 31 individuals in the intervention group and 31 individuals in the control group, by taking 10% more of the calculated sample against the possibility of sample loss during the study. In the quantitative part of the study, the web-based interactive nurse support program will continue for 3 months, and the application will last for 6 months in total. A text message will be sent to their phones to remind individuals to use the website. The researcher will make phone calls with the intervention group for 6 months (12 times in total), twice a month. During telephone interviews, individuals will be talking about the use of the website, the points that are not understood or need to be emphasized, their application of health promotion behaviors, the obstacles they experience during the application and the suggestions for this. Healthy Lifestyle Behaviors Scale II, General Self-Efficacy Scale and Dutch Eating Behavior Questionnaire (DEBQ) will be used as measurement tools. Data collection forms will be applied to the intervention and control group three times in total, before starting the Web-based interactive nurse support program, at the end of the Web-based interactive nurse support program (in the 3rd month) and in the 6th month.After each assessment moment, the data obtained will be exported to the "Statistical Package for Social Sciences Software" (SPSS).

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Sivas, Turkey
        • Recruiting
        • Sivas Cumhuriyet University
        • Contact:
          • EZGİ YILDIZ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteering to participate in the study,
  • 18 years of age and above,
  • at least two years past bariatric surgery and a history of weight gain,
  • speaking Turkish,
  • having no hearing, vision and understanding problems,
  • independent in daily life activities,
  • without dementia or alzheimer's diagnosis,
  • literate individuals
  • mobile phones and internet connections will be included in the study.

Exclusion Criteria:

  • Individuals who are unable to use a computer or smart phone,
  • have chronic illnesses,
  • are pregnant,
  • illiterate,
  • who are currently participating in any healthy lifestyle program at least 2 months ago will not be included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Gruop

Web-based interactive nurse support program with the intervention group will continue for 3 months, the implementation will last 6 months in total. Individuals in the intervention group will be able to access the training content by accessing the website designated for the study from devices such as computers or mobile phones.

Data collection forms will be applied to the intervention group 3 times in total, before starting the Web-based interactive nurse support program, at the end of the Web-based interactive nurse support program (in the 3rd month) and in the 6th month.
Behavioral: Web-Based Interactive Nurse Support Program Based on Health Promotion Model
Nursing education will be given on healthy behaviors such as nutrition, exercise, health responsibility and stress management according to the health promotion model. The researcher will make phone calls with the intervention group for 6 months (12 times in total), twice a month. During telephone interviews, individuals will be talking about the use of the website, the points that are not understood or need to be emphasized, their application of health promotion behaviors, the obstacles they experience during the application and the suggestions for this.
No Intervention: Control Group
Web-based interactive nurse support program will not be opened to the control group, only access to data collection tools will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Lifestyle Behaviors Scale II
Time Frame: 6 months
The scale measures health-promoting behaviors in relation to an individual's healthy lifestyle. The scale consists of 52 items in total. The scale has 6 sub-dimensions: health responsibility, physical activity, nutrition, spiritual development, interpersonal relationships, and stress management. For the whole scale, the lowest score is 52, the highest score is 208.
6 months
Dutch Eating Behavior Questionnaire (DEBQ)
Time Frame: 6 months
The scale consists of 33 items. It has sub-dimensions such as emotional eating, restrictive eating, external eating. Items in the scale are evaluated with a 5-point Likert scale (1: never, 2: rarely, 3: sometimes, 4: often, 5: very often).
6 months
General Self-Efficacy Scale
Time Frame: 6 months
It is a scale used to determine the general self-efficacy of adults. The scale, which consists of 17 items in total, is answered in the five-point Likert type. The score for each question ranges from 1 (none) to 5 (very good). The total score that can be obtained from the scale is between 17 and 85. The scale has 3 sub-dimensions in total. The increase in the total score of the scale indicates that the self-efficacy belief increases.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Investigators

  • Study Director: Şerife KARAGÖZOĞLU, Prof. Dr, Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

April 23, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SivasCumhuriyetU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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