Clinical trial NCT05236881: Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity
Official title: Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
mHealth
mobile application
self-management
self-care
adherence
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: %TWL at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: %TWL at 2 months
timeFrame: 2 months
measure: %EWL at 2 and 4 months
timeFrame: 2 and 4 months
measure: BMI change at 2 and 4 months
timeFrame: Baseline, 2 and 4 months
measure: Waist change at 2 and 4 months
timeFrame: Baseline, 2 and 4 months
measure: Blood pressure change at 2 and 4 months
timeFrame: Baseline, 2 and 4 months
measure: HbA1c change at 2 and 4 months
timeFrame: Baseline, 2 and 4 months
measure: Mediterranean diet adherence change at 4 months
timeFrame: Baseline and 4 months
measure: IPAQ change at 4 months
timeFrame: Baseline and 4 months
measure: ACTA change at 4 months
timeFrame: Baseline and 4 months
measure: Adherence to records
timeFrame: 2 and 4 months
measure: Adherence to recommendations
timeFrame: 2 and 4 months
measure: Adherence to visits
timeFrame: 2 and 4 months
measure: Adherence to the app
timeFrame: 2 months after the end of the study
measure: Quality of life change at 4 months
timeFrame: Baseline and 4 months
measure: Satisfaction with the app
timeFrame: 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: