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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868279
• Other study ID #: SivasCumhuriyetU
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: August 2022

Study information

• Verified date: May 2022
• Source: Cumhuriyet University
• Contact: Ezgi YILDIZ
• Phone: 05434236118
• Email: ezgiyildiz58[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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).	6 months
Primary	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.	6 months