Digital Intervention for the Modification of Lifestyles (iGame)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

NCT02016014

Healthy Subjects Without Cardiovascular Disease

COMPLETED NA

Health Game Intervention to Promote the Physical Activity of Early Adolescents

NCT03279497

Physical Activity Health Behavior

UNKNOWN NA

Effectiveness of and Engagement in a Mobile Exergame With Tailored Feedback

NCT03659604

Physical Activity Health Behavior

COMPLETED NA

Study on the Effect of a Gamified Health Education Programme on Primary School Children

NCT07276412

Gamification in Health Education Health Education

RECRUITING NA

Impact an Educational Multimodal Intervention to Improve Healthy Habits in Adolescents.

NCT07065097

Diet, Healthy Adolescent Overweight Child Nutrition Sciences +3 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain Oncology Depression Sedentary Lifestyle Sedentary Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The system of randomization for the participants is through an external computer system.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention: digital intervention Behaviour Change Technique

The assigned participants will receive an intervention based on gamification and the use of behavior change techniques to reduce sedentary lifestyle. Thus, a new mobile application will be used for 12 weeks that proposes to the user the realization of activities with the aim of reducing their sedentary behavior. The development of the application is based on previous analyzes that propose 6 clusters that encompass 33 factors that influence sedentary behavior. In this way, the application is designed to act on the two accessible: social support and behavior. On the social support, he proposes to the user to share his achievements in social networks or in an internal network of game users. In terms of habit modification, behavior modification strategies proposed in the Michie et al. (2013) taxonomy are applied, such as the following: establishment of personalized goals, rewards and reminders, awareness of achievements achieved, among others

Group Type EXPERIMENTAL

Digital intervention

Intervention Type BEHAVIORAL

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

Control Group

The control group will receive the usual indications about the harms of sedentary lifestyle and the benefits of physical activity, not receiving specific intervention. In case the use of the intervention applied in the experimental group is beneficial, the participants assigned to the control group will be offered the opportunity to receive the intervention outside the study to allow the benefit to be used.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No