Digital Intervention for the Modification of Lifestyles (iGame)

NCT04019119 | Completed

• 1 other identifier: 823871-iGame
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Low Back Pain; Depression; Sedentary Lifestyle; Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• Change in International Physical Activity Questionnaires (IPAQ)

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

  Change from baseline amount of physical activity at 3 months

Secondary Outcomes (10)

• International Sedentary Assessment Tool (ISAT)

  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)

  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.

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

  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.

• Piper Fatigue Scale (PFS). Oncology breast survivors subgroup

  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.

• Fear-avoidance Components Scale (FACS). Oncology breast survivors subgroup

  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 (5)

• Age

  Baseline

• Gender

  Baseline

• Height

  Baseline

Study Arms (2)

Intervention: digital intervention Behaviour Change Technique

EXPERIMENTAL

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

Behavioral: Digital intervention

Control Group

NO INTERVENTION

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.

Interventions

Digital intervention BEHAVIORAL

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

Intervention: digital intervention Behaviour Change Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Several mental illness
• Several illness that limits physical ability
• Phobia for digital technologies
• Difficulty in attending study measurements

Sponsors & Collaborators

• University of Malaga: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (1)

Antonio Cuesta Vargas

Málaga, Spain

Location

Related Publications (5)

• Edwards 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 BACKGROUND

• Michie 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 BACKGROUND

• Hoeppner 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 BACKGROUND

• Wolf 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 BACKGROUND

• Cuesta-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 DERIVED

MeSH Terms

Conditions

Low Back Pain; Neoplasms; Depression; Sedentary Behavior

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The system of randomization for the participants is through an external computer system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: September 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: September 28, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Free access since its publication in impact journals (Q1 - Q2).
• Access Criteria: Open access.

Locations

ES (1)