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

Not Applicable

• Conditions: Obesity; Overweight
• Interventions: Behavioral: APP + health advice; Behavioral: health advice

• Registration Number: NCT02308176
• Lead Sponsor: Basque Health Service

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-04
• Study Start: 2015-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11
• Primary Completion: 2017-05
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	APP + health advice	health advice and app installation in patient's mobile
control group	health advice	health advice

Primary Outcome Measures

Name	Time	Method
weight reduction	at 6 months	reduction of weight

Secondary Outcome Measures

Name	Time	Method
smoking cessation	at 6 and 12 months	quitting tobacco (yes / no)
waist circumference	at 6 and 12 months
BMI	at 6 and 12 months
blood pressure	at 6 and 12 months
satisfaction	at 12 months	satisfaction questionnaire
heart rate	at 6 and 12 months
plasma cholesterol	at 12 months
index of physical exercise	at 12 months	index of physical exercise (IPAQ) (METs)

Trial Locations

Locations (3)

Comarca Araba (Salburua Health Center); 🇪🇸 Vitoria-gasteiz, Alava, Spain

Comarca Araba (Zabalgana Health Center); 🇪🇸 Vitoria-gasteiz, Alava, Spain

Comarca Araba (Lakubizkarra Health Center); 🇪🇸 Vitoria-gasteiz, Alava, Spain