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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04868279
Enrollment
62
Registered
2021-04-30
Start date
2021-04-23
Completion date
2022-08-31
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

Keywords

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

Brief 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.

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).

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.

Sponsors

Cumhuriyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

In a randomized controlled study, blinding will be done in terms of statistician and reporting. Research data will be encoded and transferred to the computer without specifying the intervention and control group (for example; A group and B group). The analysis of these data coded in terms of groups will be done by a statistician. After the statistical analysis is done and the research report is written, the researcher will explain the coding for the intervention and control group. In this way, detection bias, statistical bias and reporting bias will be controlled.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Healthy Lifestyle Behaviors Scale II6 monthsThe 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.
Dutch Eating Behavior Questionnaire (DEBQ)6 monthsThe 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).
General Self-Efficacy Scale6 monthsIt 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEzgi YILDIZ
ezgiyildiz58@hotmail.com05434236118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026