About this trial
BACKGROUND: Applications for mobile devices in patients with obesity offer a great opportunity to improve the quality of care and the monitoring of patients in bariatric surgery programs. This is especially pressing in the context of an increasing prevalence of obesity, and longer waiting lists in bariatric surgery programs.
OBJECTIVES: The main objective is to evaluate the efficacy of a digital platform on mobile devices in obesity and bariatric surgery programs. Investigators will compare weight loss at 12 months after surgery in patients in the standard of care program and those in a semi-attendance program with digital support through a mobile application. As secondary objectives, it will be compared: (1) the number medical complications, the quality of life and satisfaction, physical activity, diet and attrition at 12 months after surgery. Investigators will also study the patient interaction with the platform and social networks.
TRIAL DESIGN: Randomized, non-inferiority clinical trial with a 12-month follow-up.
METHODS: 72 patients will be randomized (1: 1) to standard of care program and to semi-attendance program with digital support from the bariatric surgery program waiting list. Inclusion criteria: age between 18 and 60 years, body mass index between 35-50kg/m2, candidates for the sleeve gastrectomy technique, and possession of a mobile device. Participants will be evaluated before and 12 months after surgery. Variables: anthropometric measurements, medical complications during follow-up, quality of life, diet and physical activity questionnaires. Primary endpoint: weight loss 12 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI between 35-50kg/m2
Bariatric surgery candidates
Disqualifiers
Non-controlled psychiatric disorder
Pregnancy desire in the next 12 months
Do not have mobile devices (smartphone)
Language barrier with Spanish.
Trial design
Parallel
Treatments tested in this trial
Obemar platform
Other interventionOnline platform for education and follow-up
Treatment groups
Trial outcomes
Primary outcomes
Weight loss
The percentage of total weight loss at 12 months after bariatric surgery.
Secondary outcomes
Medical-surgical complications.
The variables corresponding to the biochemical and hematological determinations will be collected prior and 12 months after surgery. Surgical complications will be recorded using ordinal variables according to the Clavien-Dindo scale during the first 30 days after surgery. From the 30th day all complications will be recorded as a nominal variable. We will also record non-planned care activity that will include the number of emergency visits, readmissions and reinterventions.
Diet quality.
It will be recorded using the "Short Diet Quality Screener" (sDQS) questionnaire validated in spanish, before and 12 months after surgery. The total possible score ranges from 18 to 54, where higher scores mean worse results.
Degree of physical activity.
It will be evaluated using the reduced version of the physical activity questionnaire of Minnesota (Minnesota Leisure Time Physical Activity Questionnaire) before and 12 months after surgery, validated in spanish. Metabolic equivalent of task (MET) are measured through this questionnaire. More METs means more exercise.
Degree of satisfaction and quality of life.
The first one will be recorded using a categorical scale. The second one Through the Short Form -36 quality of life questionnaire. Score ranges from 0 to 100, meaning 0 the worst result and 100 the best.
Locations
Sponsors and contacts
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