Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorParc de Salut Mar

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Obemar platform

    Other intervention

    Online platform for education and follow-up

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Semi-attendance.Experimental treatment 1 intervention
Group B: Control group.No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Weight loss

The percentage of total weight loss at 12 months after bariatric surgery.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
1 year
4

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.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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