PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS). VHIR Pilot.

Study Overview
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Brief Summary
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The goal of the MI field test is to assess users' overall satisfaction, usability and acceptability of the PRECIOUS system, and to explore if MI in combination with gamification principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is pursued to trigger behavior change and build up motivation to maintain sustained change towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore users' acceptance of PRECIOUS system in an early stage of its development. Considering that this is a pilot test, feedback and outcomes obtained will serve to refine and adjust PRECIOUS system concept and architecture.

Detailed Description
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The pilot test will recruit 30 morbidly obese pre-diabetic patient and they will be randomized into three groups: Group 1. Treatment as usual; Group 2. PRECIOUS system; Group 3. PRECIOUS system and Motivational Interviewing counseling. Researchers of this study will contact telephonically with potential participants and will ask for voluntary participation. Among those who agree, a face-to-face appointment at the reference hospital will be scheduled. In this appointment, general information on the study objectives and procedures will be offered. The length of intervention will be 3 months with the following scheduled follow-up appointments: week 2 (considering baseline as week 1), week 5, week 8 and week 12. In the follow-up appointments 2, 5 and 8, only doubts and questions regarding system use will be addressed (not specific measures will be collected). Two types of measures will be assessed: 1) Primary outcome measures (at the end of the test) to assess usability, satisfaction, user's acceptance, and effectiveness of PRECIOUS system; and 2) Secondary outcome measures (baseline and final assessment) to assess different aspects of lifestyle and health habits. In addition, all patients will use a device to record heart rate during 3 consecutive days (week 1 and 12).

Official Title
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PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Intervention 1
* Behavioral: Intervention 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must be under the care of medical specialists who adheres to national guidelines for morbid obesity or pre-diabetic conditions. Age older than 18 years. Body max index (BMI): ≥ 30 mg/m2. Pre-diabetic condition following ADA criteria: fasting plasma glucose level from 5.6mmol/L (100 mg/dL) to 6.9mmol/L (125 mg/dL). Patients must be able to participate, understand and complete questionnaires in Spanish language. Patients must refer to be used to use multimedia platforms such as PDAs, tablets, laptops, smart phones or personal computers in a regular basis. Exclusion Criteria: Any mental (e.g. cognitive impairment, severe psychopathology not stabilized) or physical condition that could interfere with the successful application of the research protocol. Patients will be recruited from specialist outpatient consultation at Vall d'Hebron Research Institute (VHIR). All patients must be under the care of specialists who adhere to national guidelines.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1. Control<br> | |
| Experimental: Group 2. Intervention 1<br> | Behavioral: Intervention 1<br>* Bodyguard + Precious App. Short onsite training session on how to use the system.<br>|
| Experimental: Group 2. Intervention 2<br> | Behavioral: Intervention 2<br>* Bodyguard + Precious App + Motivational Interviewing. Face to face counseling session followed by a short onsite training session on how to use the system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' subjective assessment of usability of the PRECIOUS system | o Numeric scale 0-10 & 10 items, 5-point Likert Scale, 0-100 | At the end of the test (Session 5, week 12) | 
| Satisfaction with the PRECIOUS system | o 16 Numeric scales 0-10 | At the end of the test (Session 5, week 12) | 
| User's acceptance of the PRECIOUS system | o 4 Numeric scales 0-10, based on QUIS7 | At the end of the test (Session 5, week 12) | 
| Effectiveness of the PRECIOUS system | o Difference between the control group and the intervention groups regarding engagement and adherence to targeted healthy habits based on MCID between groups of the PRECIOUS system. | At the end of the test (Session 5, week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics and clinical data | o Ad hoc protocol (17 items) | Session 1 (week 1) and Session 5 (week 12) | 
| Health-related quality of life | o SF12v2: 12 items | Session 1 (week 1) and Session 5 (week 12) | 
| Weight management | o S-Weight (5 items) & P-Weight (34 items) | Session 1 (week 1) and Session 5 (week 12) | 
| Severity of the core symptoms of Depression, Anxiety & Stress | o DASS (21 items) | Session 1 (week 1) and Session 5 (week 12) | 
| Physical activity | o Data provided by the app | Continuous measure (intervention groups) | 
| Nutritional habits | o Data provided by the app | Continuous measure (intervention groups) | 
| Alcohol consumption | o Audit (10 items) | Session 1 (week 1) and Session 5 (week 12) | 
| Tobacco use | o Fagerström (6 items) | Session 1 (week 1) and Session 5 (week 12) | 
| Sleep quality | o Pittsburg Quality of Sleep index (18 items) | Session 1 (week 1) and Session 5 (week 12) | 
| Assessment of the motivational aspects of PRECIOUS | o 23 numeric scales 0-10 | Session 5 (week 12) Intervention groups | 
| Bodyguard 2 device | Heart Rate Variability measurement | Session 1 (week 1) and Session 5 (week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Motivational Interviewing, Obesity, Prevention, Diet, Physical Activity, Health Preventive System