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

Obesity Clinical Trial

— AD01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02308176
• Other study ID #: AKTIDIET
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2014
• Last updated: January 10, 2017
• Start date: September 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2017
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• APP + health advice
health advice and reinforcement to it
• health advice
health advice

Locations

Country	Name	City	State
Spain	Comarca Araba (Lakubizkarra Health Center)	Vitoria-gasteiz	Alava
Spain	Comarca Araba (Salburua Health Center)	Vitoria-gasteiz	Alava
Spain	Comarca Araba (Zabalgana Health Center)	Vitoria-gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight reduction	reduction of weight	at 6 months	No
Secondary	BMI		at 6 and 12 months	No
Secondary	blood pressure		at 6 and 12 months	No
Secondary	heart rate		at 6 and 12 months	No
Secondary	smoking cessation	quitting tobacco (yes / no)	at 6 and 12 months	No
Secondary	waist circumference		at 6 and 12 months	No
Secondary	plasma cholesterol		at 12 months	No
Secondary	satisfaction	satisfaction questionnaire	at 12 months	No
Secondary	index of physical exercise	index of physical exercise (IPAQ) (METs)	at 12 months	No