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

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
APP + health advice
health advice
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comarca Araba (Salburua Health Center)
  • Comarca Araba (Lakubizkarra Health Center)
  • Comarca Araba (Zabalgana Health Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention group

control group

Arm Description

health advice and app installation in patient's mobile

health advice

Outcomes

Primary Outcome Measures

weight reduction
reduction of weight

Secondary Outcome Measures

BMI
blood pressure
heart rate
smoking cessation
quitting tobacco (yes / no)
waist circumference
plasma cholesterol
satisfaction
satisfaction questionnaire
index of physical exercise
index of physical exercise (IPAQ) (METs)

Full Information

First Posted
December 2, 2014
Last Updated
January 10, 2017
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT02308176
Brief Title
Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
health advice and app installation in patient's mobile
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
health advice
Intervention Type
Behavioral
Intervention Name(s)
APP + health advice
Intervention Description
health advice and reinforcement to it
Intervention Type
Behavioral
Intervention Name(s)
health advice
Intervention Description
health advice
Primary Outcome Measure Information:
Title
weight reduction
Description
reduction of weight
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
BMI
Time Frame
at 6 and 12 months
Title
blood pressure
Time Frame
at 6 and 12 months
Title
heart rate
Time Frame
at 6 and 12 months
Title
smoking cessation
Description
quitting tobacco (yes / no)
Time Frame
at 6 and 12 months
Title
waist circumference
Time Frame
at 6 and 12 months
Title
plasma cholesterol
Time Frame
at 12 months
Title
satisfaction
Description
satisfaction questionnaire
Time Frame
at 12 months
Title
index of physical exercise
Description
index of physical exercise (IPAQ) (METs)
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Comarca Araba (Salburua Health Center)
City
Vitoria-gasteiz
State/Province
Alava
ZIP/Postal Code
01003
Country
Spain
Facility Name
Comarca Araba (Lakubizkarra Health Center)
City
Vitoria-gasteiz
State/Province
Alava
ZIP/Postal Code
01010
Country
Spain
Facility Name
Comarca Araba (Zabalgana Health Center)
City
Vitoria-gasteiz
State/Province
Alava
ZIP/Postal Code
01015
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31093681
Citation
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.
Results Reference
derived

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

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