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Status unknownNCT04868279Updated May 25, 2022

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

An interventional study of Web-Based Interactive Nurse Support Program Based on Health Promotion Model in Bariatric Surgery Candidate, sponsored by Cumhuriyet University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by Cumhuriyet University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Bariatric Surgery Candidate

Keywords

  • Weight regain after bariatric surgery
  • Health Promotion Model
  • Web-based interactive nurse support program
  • Healthy lifestyle behavior
  • Self-sufficiency
03

In context

Lead sponsor

Cumhuriyet University is the lead sponsor of 128 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralWeb-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.

06

What researchers measure

Primary outcomes

  1. Healthy Lifestyle Behaviors Scale II

    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.

    Time frame: 6 months

  2. Dutch Eating Behavior Questionnaire (DEBQ)

    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).

    Time frame: 6 months

  3. General Self-Efficacy Scale

    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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Sivas Cumhuriyet University
    Sivas, Turkey
    • EZGİ YILDIZ · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04868279
Lead sponsor
Cumhuriyet University
Responsible party
Ezgi Yildiz (Research Assistant, Cumhuriyet University) — Principal investigator
First posted
Apr 30, 2021
Start date
Apr 23, 2021
Primary completion
Jun 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
May 25, 2022

Study contacts

Ezgi YILDIZ
Contact
ezgiyildiz58@hotmail.com
05434236118
Şerife KARAGÖZOĞLU, Prof. Dr
study director · Cumhuriyet University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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