Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits (Diet and Sport) in a Population of Patients Obese or Overweight Adults Patients

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: APP + health advice
* Behavioral: health advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI> = 25 mg / kg Holder smartphone Sign informed consent Exclusion Criteria: Presence of physical or mental illnesses that prevent the realization of physical activity Be participating in another research project Pregnancy or lactation Patients who are on diet or drug treatment for weight loss History of myocardial infarction or stroke

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>health advice and app installation in patient's mobile | Behavioral: APP + health advice<br>* health advice and reinforcement to it<br>|
| Placebo Comparator: control group<br>health advice | Behavioral: health advice<br>* health advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight reduction | reduction of weight | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | at 6 and 12 months | 
| blood pressure |  | at 6 and 12 months | 
| heart rate |  | 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 |