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

Study Overview
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Brief Summary
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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).

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

Conditions
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Obesity

Intervention / Treatment
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* Device: ANíMATE mobile application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANíMATE mobile application<br>Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANíMATE mobile application | Device: ANíMATE mobile application<br>* 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.<br>|
| No Intervention: Standard care<br>Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %TWL at 4 months | Percentage of total weight loss (%TWL) at 4 months | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %TWL at 2 months | Percentage of total weight loss (%TWL) at 2 months | 2 months | 
| %EWL at 2 and 4 months | Percentage of excess weight loss (%EWL) at 2 and 4 months | 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 | Baseline, 2 and 4 months | 
| Waist change at 2 and 4 months | Change in waist circumference (cm) from baseline to 2 and 4 months | 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 | Baseline, 2 and 4 months | 
| HbA1c change at 2 and 4 months | Change in HbA1c percent from baseline to 2 and 4 months | 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 | 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 | 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 | Baseline and 4 months | 
| Adherence to records | Percentage of records (weight, diet) at 2 and 4 months | 2 and 4 months | 
| Adherence to recommendations | Percentage of recommendations given by the medical team followed at next visit | 2 and 4 months | 
| Adherence to visits | Percentage of face-to-face visits attended | 2 and 4 months | 
| Adherence to the app | Percentage of patients who continue using the 2 months app after the end of the study | 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 | 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 | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, mHealth, mobile application, self-management, self-care, adherence