CompletedNCT05236881ANíMATEUpdated Nov 18, 2025

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

An interventional study of ANíMATE mobile application in Obesity, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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).

Conditions studied

Obesity

Browse trials for

Obesity 6,296

Keywords

Obesity
mHealth
mobile application
self-management
self-care
adherence

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 36 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Experimental
ANíMATE mobile application
Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application
Device: ANíMATE mobile application
No intervention
Standard care
Standard care protocol (3 face-to-face visits: basal, 2 and 4 months)

Interventions

DeviceANíMATE mobile application
mHealth tool ANíMATE (Adherence, Nutrition, PhysIcal Activity, Motivation, medicAtion, Technology and Empowerment) allows the recording of data related to diet and exercise and feedback on behavior through an intelligent data analysis system.

What researchers measure

Primary outcomes

%TWL at 4 months
Percentage of total weight loss (%TWL) at 4 months
Time frame: 4 months

Secondary outcomes

%TWL at 2 months
Percentage of total weight loss (%TWL) at 2 months
Time frame: 2 months
%EWL at 2 and 4 months
Percentage of excess weight loss (%EWL) at 2 and 4 months
Time frame: 2 and 4 months
BMI change at 2 and 4 months
Change in body mass index (BMI) (kg/m\^2) from baseline to 2 and 4 months
Time frame: Baseline, 2 and 4 months
Waist change at 2 and 4 months
Change in waist circumference (cm) from baseline to 2 and 4 months
Time frame: Baseline, 2 and 4 months
Blood pressure change at 2 and 4 months
Change in systolic and diastolic blood pressure (mmhg) from baseline to 2 and 4 months
Time frame: Baseline, 2 and 4 months
HbA1c change at 2 and 4 months
Change in HbA1c percent from baseline to 2 and 4 months
Time frame: Baseline, 2 and 4 months
Mediterranean diet adherence change at 4 months
Change in mediterranean diet adherence questionnaire score (0\*-14, \*indicates worse questionnaire results) from baseline to 4 months
Time frame: Baseline and 4 months
IPAQ change at 4 months
Change in International Physical Activity Questionnaire (IPAQ) score (cathegory results: low/inactive\*, moderate or high, \*indicates worse questionnaire results) from baseline to 4 months
Time frame: Baseline and 4 months
ACTA change at 4 months
Change in attitudes towards change in eating disorders (ACTA) questionnaire score (0\*-236, \*indicates worse questionnaire results) from baseline to 4 months
Time frame: Baseline and 4 months
Adherence to records
Percentage of records (weight, diet) at 2 and 4 months
Time frame: 2 and 4 months
Adherence to recommendations
Percentage of recommendations given by the medical team followed at next visit
Time frame: 2 and 4 months
Adherence to visits
Percentage of face-to-face visits attended
Time frame: 2 and 4 months
Adherence to the app
Percentage of patients who continue using the 2 months app after the end of the study
Time frame: 2 months after the end of the study
Quality of life change at 4 months
Change in Short-Form Health Survey SF-36 questionnaire score (0\*-100, \*indicates worse questionnaire results) from baseline to 4 months
Time frame: Baseline and 4 months
Satisfaction with the app
Satisfaction questionnaire in relation to the use of the app score (0\*-20, \*indicates worse questionnaire results) in the intervention group at the end of the study
Time frame: 4 months

Study locations

1 site

Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05236881
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party: Sponsor
First posted: Feb 11, 2022
Start date: Apr 20, 2022
Primary completion: Nov 13, 2024
Completion: Jan 31, 2025
Last update: Nov 18, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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