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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANĂMATE mobile application | Experimental | Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) + ANĂMATE mobile application |
|
| Standard care | No Intervention | Standard care protocol (3 face-to-face visits: basal, 2 and 4 months) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANĂMATE mobile application | Device | mHealth tool ANĂMATE (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. |
| Measure | Description | Time Frame |
|---|---|---|
| %TWL at 4 months | Percentage of total weight loss (%TWL) at 4 months | 4 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |