Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits (AD01)

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: APP + health advice; Behavioral: health advice

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria-gasteiz, Alava, Spain, 01003
      • Comarca Araba (Salburua Health Center)
    • Vitoria-gasteiz, Alava, Spain, 01010
      • Comarca Araba (Lakubizkarra Health Center)
    • Vitoria-gasteiz, Alava, Spain, 01015
      • Comarca Araba (Zabalgana Health Center)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Basque Health Service

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: AKTIDIET