Digital Intervention for the Modification of Lifestyles (iGame)

N/ACompletedNCT04019119

University of Malaga48 enrolled

Overview

The objective of the project is to analyze the clinical effectiveness of a gamifield mHealth application (iGAME) and developed in the context of lifestyle modification, but with the approach of the Behaviour Change Technique, through a randomized clinical trial that affects secondary prevention in three clinical subtypes of noncommunicable diseases, where lifestyle modification is the center of its best practice.

Despite digital exposure, gamification of health has been widely understood and often applied ad hoc in health products. Attempts to incorporate game concepts into digital health applications have not led to demonstrated success. Recent studies have shown that only 4% of the best rated health apps in Apple stores and Google Play (based on revenue and download) have gamification elements, but less than 5% of these health apps have been included in the application library of National Health Service. In addition, very little of 5% was developed for industry and health professionals. If the power of digital technologies, such as games for clear clinical benefits, is not released, opportunities for social and economic burial will be lost for all stakeholders in the digital health and digital economy ecosystem. A number of factors in this barrier: * The best techniques for the design of activities. The majority of health gamification has little consistent support of health or clinical theories. * The high cost and complexity of the digital game development process. The majority of gaming functions are based on best practices in the development of digital games. * Little participation of researchers in health, professionals and participation of the end user in the process of gamification development. Very little health gamification is formally evaluated clinically. The initial hypothesis is that after 12 weeks of participation in the original iGAME application, participants will increase the quantity and distribution of energy consumption, through the estimation of results, data based on acceleration and questionnaires. automatic information In addition, it will also improve satisfaction and lifestyle, as well as the consumption of health services.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Low Back Pain Oncology Depression Sedentary Lifestyle Sedentary Behavior

Interventions

Digital interventionBEHAVIORAL

The information group will receive through a mobile application tips to reduce sedentary lifestyle and promote healthy living habits.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

IInclusion Criteria for Breast Cancer Survivors subgroup: * Men and women * Age between 18 and 65 years * Sedentary behavior recognized by the subject: \<1.5 METS per day and sitting\> 4h / d . * Intention to change sedentary behavior manifested by the subject * Survivors of breast cancer. Women with a clinical history of diagnosis of primary breast cancer, having completed surgical treatment, radiotherapy or chemotherapy at least three months before starting the study intervention Inclusion Criteria for Low Back Pain subgroup: * Men and women * Age between 18 and 65 years * Sedentary behavior recognized by the subject: \<1.5 METS per day and sitting\> 4h / d . * Intention to change sedentary behavior manifested by the subject * Mild low back pain of mechanical or degenerative cause diagnosed by a primary care physician Inclusion Criteria for Depression subgroup: * Men and women * Age between 18 and 65 years * Sedentary behavior recognized by the subject: \<1.5 METS per day and sitting\> 4h / d . * Intention to change sedentary behavior manifested by the subject * Mild depression Diagnosis in Primary Care using the MINI interview to rule out another severe mental pathology and the PHQ-9 questionnaire to categorize the level of depressive severity Exclusion Criteria: * Several mental illness * Several illness that limits physical ability * Phobia for digital technologies * Difficulty in attending study measurements

Locations (1)

Antonio Cuesta Vargas

Málaga, Spain

Outcomes

Primary Outcomes

Change in International Physical Activity Questionnaires (IPAQ)

Patient reported outcome: Physical activity related to a person's health

Time frame: Change from baseline amount of physical activity at 3 months

Secondary Outcomes

International Sedentary Assessment Tool (ISAT)

Patient reported outcome. It is an evaluation of sedentary behavior. An alternative way to the use of accelerometry for the calculation of energy consumption.

Time frame: Five measures will be carried out. 1st the beginning of the study. 2nd measurement after 1.5 months. 3rd measurement 3 months from the beginning. 4th measure 6 months from the beginning. 5th measure: 12 months from the begin.

European Quality of Life-5 Dimensions (Euroqol-5D, EQ-5D)

Patient reported outcome. Health index that relates quantity and quality of life. It is applied with a short questionnaire and a visual analogue scale. Each dimension is rated in five levels from 1 ("I have no problem with...") to 5 ("I am unable to..."). Each participant indicates the level that best reflects their state for each of the five dimensions, with which their health status is described by five digits that take values from 1 to 5, with health status 11111 being considered a priori the best state of health and 55555 the worst state of health. The visual analogue scale is scored from 0 (without pain) to 100 (worst pain).

MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS)

Patient reported outcome: tool designed to assess patient satisfaction with physiotherapy care through intrinsic and extrinsic factors. The instrument consists of 10 specific items and 2 global items scored from 1 (strongly disagree) to 5 (strongly agree). The means of items 1 through 3 and 4 through 10 are calculated to determine the mean score for external and internal subscales, respectively. Total score from 0 (worst patient satisfaction) to 5 (best patient satisfaction).

Data from ClinicalTrials.gov

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