Digital Intervention for the Modification of Lifestyles (iGame)

Depression Clinical Trial

Official title:

Effectiveness of a Digital Intervention Based on Modification of Lifestyles in Secondary Prevention: iGAME Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04019119
• Other study ID #: 823871-iGame
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 28, 2025

Study information

• Verified date: June 2024
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: September 28, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Antonio Cuesta Vargas	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Horizon 2020 - European Commission

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	years old	Baseline
Other	Gender	Male or female.	Baseline
Other	Height	measure in meters	Baseline
Other	Weight	measure in kg	Baseline
Other	Body mass index (BMI)	kg/m2	Baseline
Primary	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	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.	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.
Secondary	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).	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.
Secondary	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).	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.
Secondary	Piper Fatigue Scale (PFS). Oncology breast survivors subgroup	Patient reported outcome:Questionnaire designed to evaluate cancer-related fatigue in breast cancer survivors. Composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue: behavioral/severity, affective meaning, sensory and cognitive/mood. To calculate the total fatigue score, add the 22-item scores together and divide by 22 in order to keep the score on the same numeric "0" to "10" scale. Severity codes: 0 none, 1-3 mild, 4-6 moderate, 7-10 severe.	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.
Secondary	Fear-avoidance Components Scale (FACS). Oncology breast survivors subgroup	Patient reported outcome: quantification of existing fear-avoidance components in patients with medical conditions associated with pain. 20 question related to painful medical condition. 5 = Completely Agree 4 = Mostly Agree 3 = Slightly Agree 2 = Slightly Disagree 1 = Mostly Disagree0 = Completely Disagree. Higher values represent a worse outcome.	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.
Secondary	Rolland-Morris Questionnaire (RMQ). Low back pain subgroup	patient reported outcome. Assessment the degree of physical disability related to non-specific low back pain, understanding physical disability as limitation in the performance of activities of daily life.	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.
Secondary	Spine Functional Index (SFI). Low back pain subgroup	Patient reported outcome.Assessment the functionality of the column as a whole	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.
Secondary	MINI Interview. Depression Subgroup.	Brief structured diagnostic interview to generate diagnoses DSM-IV and ICD-10	Baseline
Secondary	PHQ-9	Patient reported outcome. Assessment the presence and severity of depressive symptoms, relating to the last days of the previous week.	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.
Secondary	International Physical Activity Questionnaires (IPAQ)	Patient reported outcome: Physical activity related to a person's health	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.