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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308176
Acronym
AD01
Enrollment
107
Registered
2014-12-04
Start date
2015-09-30
Completion date
2017-11-30
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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.

Interventions

BEHAVIORALAPP + health advice

health advice and reinforcement to it

BEHAVIORALhealth advice

health advice

Sponsors

Basque Health Service
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
weight reductionat 6 monthsreduction of weight

Secondary

MeasureTime frameDescription
BMIat 6 and 12 months
blood pressureat 6 and 12 months
heart rateat 6 and 12 months
index of physical exerciseat 12 monthsindex of physical exercise (IPAQ) (METs)
waist circumferenceat 6 and 12 months
plasma cholesterolat 12 months
satisfactionat 12 monthssatisfaction questionnaire
smoking cessationat 6 and 12 monthsquitting tobacco (yes / no)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026