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INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Medical advice is useful for determining changes in the habits of life of patients, however, the changes produced by the council do not last over time, so it would be necessary to establish enforcement mechanisms as with mobile technology, because it could improve the adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open randomized controlled clinical trial with clinical practice (health advice for physical activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm). Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance analysis adjusting by baseline weight, and other confounding variables (sex, age, level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | health advice and app installation in patient's mobile |
|
| control group | Placebo Comparator | health advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APP + health advice | Behavioral | health advice and reinforcement to it |
| |
| Measure | Description | Time Frame |
|---|---|---|
| weight reduction | reduction of weight | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | at 6 and 12 months | |
| blood pressure | at 6 and 12 months | |
| heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comarca Araba (Salburua Health Center) | Vitoria-Gasteiz | Alava | 01003 | Spain | ||
| Comarca Araba (Lakubizkarra Health Center) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38375882 | Derived | Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2. | |
| 31093681 | Derived | Apinaniz A, Cobos-Campos R, Saez de Lafuente-Morinigo A, Parraza N, Aizpuru F, Perez I, Goicoechea E, Trapaga N, Garcia L. Effectiveness of randomized controlled trial of a mobile app to promote healthy lifestyle in obese and overweight patients. Fam Pract. 2019 Nov 18;36(6):699-705. doi: 10.1093/fampra/cmz020. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| health advice |
| Behavioral |
health advice |
|
| at 6 and 12 months |
| smoking cessation | quitting tobacco (yes / no) | at 6 and 12 months |
| waist circumference | at 6 and 12 months |
| plasma cholesterol | at 12 months |
| satisfaction | satisfaction questionnaire | at 12 months |
| index of physical exercise | index of physical exercise (IPAQ) (METs) | at 12 months |
| Vitoria-Gasteiz |
| Alava |
| 01010 |
| Spain |
| Comarca Araba (Zabalgana Health Center) | Vitoria-Gasteiz | Alava | 01015 | Spain |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |