Clinical trial · Interventional
Digital Intervention for the Modification of Lifestyles (iGame)
Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Secondary Prevention: iGAME Controlled Randomized Clinical Trial
NCT04019119CI-TRIAL-00107634completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
| Low Back Pain | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Sedentary Behavior | — | UNRESOLVED | — |
| Sedentary Lifestyle | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention: digital intervention Behaviour Change Technique
- description
- 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
- interventionNames
- Behavioral: Digital intervention
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDEdwards EA, Lumsden J, Rivas C, Steed L, Edwards LA, Thiyagarajan A, Sohanpal R, Caton H, Griffiths CJ, Munafo MR, Taylor S, Walton RT. Gamification for health promotion: systematic review of behaviour change techniques in smartphone apps. BMJ Open. 2016 Oct 4;6(10):e012447. doi: 10.1136/bmjopen-2016-012447. PMID 27707829
- BACKGROUNDMichie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6. PMID 23512568
- BACKGROUNDHoeppner BB, Hoeppner SS, Seaboyer L, Schick MR, Wu GW, Bergman BG, Kelly JF. How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis. Nicotine Tob Res. 2016 May;18(5):1025-31. doi: 10.1093/ntr/ntv117. Epub 2015 Jun 4. PMID 26045249
- BACKGROUNDWolf JA, Moreau JF, Akilov O, Patton T, English JC 3rd, Ho J, Ferris LK. Diagnostic inaccuracy of smartphone applications for melanoma detection. JAMA Dermatol. 2013 Apr;149(4):422-6. doi: 10.1001/jamadermatol.2013.2382. PMID 23325302
- DERIVEDCuesta-Vargas AI, Biro A, Escriche-Escuder A, Trinidad-Fernandez M, Garcia-Conejo C, Roldan-Jimenez C, Tang W, Salvatore A, Nikolova B, Muro-Culebras A, Martin-Martin J, Gonzalez-Sanchez M, Ruiz-Munoz M, Mayoral F. Effectiveness of a gamified digital intervention based on lifestyle modification (iGAME) in secondary prevention: a protocol for a randomised controlled trial. BMJ Open. 2023 Jun 14;13(6):e066669. doi: 10.1136/bmjopen-2022-066669. PMID 37316318