NCT07297342

Brief Summary

The aim of this study is to assess the impact of a newly intensified digital platform following bariatric surgery. This will be measured using several questionnaires. The following objectives will be evaluated: the exact amount of weight loss achieved preoperatively with the preparatory diet; the occurrence of dumping symptoms; the assessment of quality of life (QOL); and compliance with supplement intake. By examining the impact of an enhanced digital platform, we aim to address critical questions regarding the effectiveness of improved patient support in the digital domain. Moreover, given the increasing prevalence of bariatric surgery as a therapeutic option for obesity, it is of utmost importance to identify strategies to optimize patient education and support through digital tools. This study not only contributes to the scientific understanding of digital support in bariatric care but also has important implications for the further development of the "Get Ready" application, ensuring that it remains at the forefront of providing comprehensive and patient-centered support in the evolving landscape of bariatric surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Apr 2025Jun 2027

Study Start

First participant enrolled

April 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

September 23, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Get Readyapplicationbariatriccompliance

Outcome Measures

Primary Outcomes (4)

  • Weight

    Overall weight, in kg's

    3monts, 6 months, 12 months

  • Rand-36 Health Survey

    Health survey, score 0-100 with higher score indicating better health.

    12months

  • Bloodwork

    Deficiencys in blood results

    6 months and 12 months

  • Sigstad score

    classifying dumping symptoms, score \>7 sugests dumping, score \<-4 suggests other disease.

    3months, 6 months and 122 months

Secondary Outcomes (1)

  • N° of unplanned clinical visits

    12months

Study Arms (2)

Standard GetReady application group

PLACEBO COMPARATOR

Standard GetReady application group

Other: GetReady application

Intensified GetReady application

ACTIVE COMPARATOR

Intensified GetReady application

Other: Intensified GetReady application

Interventions

Postoperative application usage

Standard GetReady application group

Postoperative application usage

Intensified GetReady application

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing bariatric surgery

You may not qualify if:

  • Previous bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Dimpna ziekenhuis

Geel, Belgium

RECRUITING

MeSH Terms

Conditions

ObesityOverweightHypertensionSleep Apnea, ObstructiveDiabetes MellitusPatient Compliance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Ruben Vanlommel, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

December 22, 2025

Study Start

April 2, 2025

Primary Completion

January 30, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations