Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Completed

Conditions: Obesity

Treatments: Device: ANíMATE mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05236881

IIBSP-ANI-2020-10

Details and patient eligibility

About

This trial main purpose is to develop and test an mHealth app aimed at improving self-management, self-care and adherence of people with obesity.

The study population are type I or II obese people, aged more than 18 years old, with or without comorbidities, who have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and access to a scale for regular weight monitoring.

Control group will follow standard care protocol and patients in the intervention group will also be provided with the app. Follow-up will be done for 16 weeks. Both groups will attend 3 face-to-face visits (baseline, 2 and 4 months).

Enrollment: 36 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age.
• People with BMI 30-39.9 kg/m2.
• Have a smartphone or tablet compatible with the app (Android version 9.0 or higher) and have sufficient capabilities to use it.
• Have access to a scale for regular weight monitoring.

Exclusion criteria

• Presence of serious major comorbidities: High blood pressure treated with > 3 drugs, diabetes mellitus treated with insulin, dyslipidemia treated with PCSK9 inhibitors, sleep apnea-hypopnea syndrome treated with CPAP, ischemic heart disease or stroke.
• Use of pharmacological treatment with influence on weight started in the 6 months prior to study entry.
• History of weight loss intervention (diet, exercise) in the 6 months prior to study entry.
• History of eating disorder.
• History of bariatric surgery.
• Use of any other app or treatment to lose weight in the 6 months prior to study entry.
• Pregnancy, short-term gestational desire or lactation.
• Any other disease or condition that may interfere with compliance with the protocol or completion of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

ANíMATE mobile application

Experimental group

Description:

Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application

Treatment:

Device: ANíMATE mobile application

Standard care

No Intervention group

Description:

Standard care protocol (3 face-to-face visits: basal, 2 and 4 months)