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The NURLIFE Program for the Management of Bariatric Surgery Patients

Design and Development of a Nurse-led Program for the Management of Bariatric Surgery Patients - The NURLIFE Program

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06020105
Acronym
NURLIFE
Enrollment
80
Registered
2023-08-31
Start date
2024-01-02
Completion date
2025-07-31
Last updated
2023-10-10

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

Conditions

Bariatric Surgery Candidate, Nurse-Patient Relations

Keywords

Case manager, e-health, Nurse case management, Bariatric surgery, Perioperative care

Brief summary

to analyze the influence of the new intervention in the perioperative period and impact on several clinical and humanistic endpoints. In the evaluation phase, an experimental, controlled, and randomized study (RCT) will be developed, with an intervention group (IG) and a control group (CG). The CG will receive the usual care and the IG, will receive the intervention for an expected period of one year. This project aims to be the first study to investigate the effect of a long-term specialized case-management intervention (face-to-face and e-health) in patients who are candidates for bariatric surgery during all the perioperative periods

Detailed description

The nurse-led case-management intervention program will allow to improve the management of the bariatric surgery process by patients in collaboration with the health team, with a view to improving health and adopting healthy lifestyles, which enhance better results. This intervention program is expected to be a mixed program with e-health technologies. Behavioural changes will be predictably one of the main objectives, with perception of the barriers and facilitators of them, from the perspective of training the patient for the physiological changes that result from the entire process of bariatric surgery. Thus, it is expected that the primary focus of the program will be health education and motivation for lifestyle changes, the promotion of healthy lifestyles and promotion of physical activity, with a view to improving anthropometric data and metabolic risk factors, as well as smoking cessation and alcoholic habits. As such, the contribution of a multidisciplinary team that is managed by a case-manager appears to be the most efficient intervention, and this activity aims to determine the set of procedures and their temporal sequence, the skills of the team, the flow of patients through the different elements of the team and the duration of the program.

Interventions

BEHAVIORALNURLIFE

After the first consultation with the surgeon, the patients will be referred to the case manager, who will carry out the first face-to-face consultation, with consequent monitoring and clarification of identified needs, following the flowchart in figure 3, being referred to the different specialties, psychology, nutrition and nursing, fostering the case manager as the central pillar of the process, which will monitor each process individually, namely the number of consultations and necessary referrals.

Sponsors

University of Évora
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital * Agree to participate in the study

Exclusion criteria

* Surgical complications * Psychiatric diseases and neurological disorders

Design outcomes

Primary

MeasureTime frameDescription
Barriers and facilitators of physical activity1 yearBarriers and facilitators of physical activity Questionnaire on open questions
Anxiety and depression1 yearSocial appearance anxiety scale (SAAS) is a16-item self-report measure; The items on the SAAS are rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely). The SAAS yields a total score, which can range from 16 to 80. Higher scores on the SAAS indicate greater social appearance anxiety.
Body image1 yearBody Image Perception Questionnaire (BIQ); the 19-item Body-Image Questionnaire; The total scores range from 0 to 72 with a higher score reflecting greater impairment and likelihood
Self-Esteem1 yearCoopersmith Self-Esteem Scale (CSES) The CSEI consists of 50 items and yields an overall score and four separate scores representing specific aspects of self-esteem, namely, general self, social self-peers, home parents, and school academic (or professional for adult form).
Body weight1 yearscale
Height1 yearstadiometer
cholesterol in mg/dl1 yearBlood sample
Glucose in mg/dl1 yearBlood sample
Mean blood pressure1 yearBlood sample
Physical Function1 yearSix-Minute Walk Test (6MWT)
Food-related aspects1 yearEating Questionnaire (EDE-Q) with 28 questions; the minimum values are 0,04 and maximum values are 4,97; Higher scores indicate greater levels of symptomatology

Secondary

MeasureTime frameDescription
physical activity level1 yearActivity Log App
Satisfaction with follow-up by nurses1 yearAssessment Form of Nurse-led Educational Activities Satisfaction questionnaire
Health-related Quality of life (IWQOL)1 yearQuality of life will be assessed using the general health and well-being questionnaire; The Impact of Weight on Quality of Life-Lite (IWQOL-Lite)© is a validated, 31-item; Scores range from 0 to 100, with 100 representing the best quality of life

Outcome results

None listed

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