Clinical trial NCT04019119: Digital Intervention for the Modification of Lifestyles (iGame)
Official title: Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Secondary Prevention: iGAME Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Back Pain
Oncology
Depression
Sedentary Lifestyle
Sedentary Behavior
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
First posted: 2019-07-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups study. One group with intervention (app mobile program); second group as control. At the end of the intervention, the control group receives advice of demonstrated effectiveness in the intervention to comply with the ethical principles.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in International Physical Activity Questionnaires (IPAQ)
timeFrame: Change from baseline amount of physical activity at 3 months
Secondary outcomes:
measure: International Sedentary Assessment Tool (ISAT)
timeFrame: 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.
measure: European Quality of Life-5 Dimensions (Euroqol-5D, EQ-5D)
timeFrame: 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.
measure: MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS)
timeFrame: 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.
measure: Piper Fatigue Scale (PFS). Oncology breast survivors subgroup
timeFrame: 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.
measure: Fear-avoidance Components Scale (FACS). Oncology breast survivors subgroup
timeFrame: 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.
measure: Rolland-Morris Questionnaire (RMQ). Low back pain subgroup
timeFrame: 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.
measure: Spine Functional Index (SFI). Low back pain subgroup
timeFrame: 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.
measure: MINI Interview. Depression Subgroup.
timeFrame: Baseline
measure: PHQ-9
timeFrame: 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.
measure: International Physical Activity Questionnaires (IPAQ)
timeFrame: 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.
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Baseline
Locations:
city: Málaga
country: Spain
facility: Antonio Cuesta Vargas
Study officials:
References:
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