ObesityANíMATENCT05236881
Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity
A study testing ANíMATE mobile application in people with Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obesity
- What is being tested?
- ANíMATE mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Obesity
- Being tested
- ANíMATE mobile application
- Keywords
- Obesity, mHealth, mobile application, self-management, self-care, adherence
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANíMATE mobile applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ANíMATE mobile application | Experimental | Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application Receives: Device: ANíMATE mobile application |
| Standard care | No intervention | Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
%TWL at 4 months
Percentage of total weight loss (%TWL) at 4 months
Measured: 4 months
Secondary outcomes (15)
%TWL at 2 months
Percentage of total weight loss (%TWL) at 2 months
Measured: 2 months
%EWL at 2 and 4 months
Percentage of excess weight loss (%EWL) at 2 and 4 months
Measured: 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
Measured: Baseline, 2 and 4 months
Waist change at 2 and 4 months
Change in waist circumference (cm) from baseline to 2 and 4 months
Measured: 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
Measured: Baseline, 2 and 4 months
HbA1c change at 2 and 4 months
Change in HbA1c percent from baseline to 2 and 4 months
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 4 months
Adherence to records
Percentage of records (weight, diet) at 2 and 4 months
Measured: 2 and 4 months
Adherence to recommendations
Percentage of recommendations given by the medical team followed at next visit
Measured: 2 and 4 months
Adherence to visits
Percentage of face-to-face visits attended
Measured: 2 and 4 months
Adherence to the app
Percentage of patients who continue using the 2 months app after the end of the study
Measured: 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
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start20 Apr 2022
- Primary completion13 Nov 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236881
- Sponsor's protocol ID
- IIBSP-ANI-2020-10
- Acronym
- ANíMATE
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an mHealth Tool (ANíMATE) to Assess Self-management, Self-care and Adherence in People With Obesity
- ClinicalTrials.gov ID
- NCT05236881
- Acronym / sponsor ID
- ANíMATE / IIBSP-ANI-2020-10
- Conditions
- Obesity
- Keywords
- Obesity, mHealth, mobile application, self-management, self-care, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANíMATE mobile application | Experimental | Device: ANíMATE mobile applicationStandard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application |
| Standard care | No intervention | –Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANíMATE mobile applicationmHealth 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. | Device | ANíMATE mobile application |
Primary outcome
%TWL at 4 months
Time frame: 4 months
Percentage of total weight loss (%TWL) at 4 months
15 secondary outcomes
%TWL at 2 months
Time frame: 2 months
%EWL at 2 and 4 months
Time frame: 2 and 4 months
BMI change at 2 and 4 months
Time frame: Baseline, 2 and 4 months
Waist change at 2 and 4 months
Time frame: Baseline, 2 and 4 months
Blood pressure change at 2 and 4 months
Time frame: Baseline, 2 and 4 months
HbA1c change at 2 and 4 months
Time frame: Baseline, 2 and 4 months
Mediterranean diet adherence change at 4 months
Time frame: Baseline and 4 months
IPAQ change at 4 months
Time frame: Baseline and 4 months
ACTA change at 4 months
Time frame: Baseline and 4 months
Adherence to records
Time frame: 2 and 4 months
Adherence to recommendations
Time frame: 2 and 4 months
Adherence to visits
Time frame: 2 and 4 months
Adherence to the app
Time frame: 2 months after the end of the study
Quality of life change at 4 months
Time frame: Baseline and 4 months
Satisfaction with the app
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANíMATE mobile application in people with Obesity, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%TWL at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.