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

NCT04868279 | Unknown

• 1 other identifier: SivasCumhuriyetU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Interventional Gruop

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Web-based interactive nurse support program will not be opened to the control group, only access to data collection tools will be provided.

Interventions

Web-Based Interactive Nurse Support Program Based on Health Promotion Model BEHAVIORAL

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.

Interventional Gruop

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

RECRUITING

Study Officials

• Şerife KARAGÖZOĞLU, Prof. Dr

  Cumhuriyet University

  STUDY DIRECTOR

Central Study Contacts

Ezgi YILDIZ

CONTACT

05434236118; ezgiyildiz58@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 30, 2021
• Study Start: April 23, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

TU (1)