Clinical trial NCT02818790: PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS). VHIR Pilot.
Official title: PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: mHealth
Motivational Interviewing
Obesity
Prevention
Diet
Physical Activity
Health Preventive System
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Aalto University
name: University of Helsinki
name: Firstbeat Technologies Ltd.
name: University of Vienna
name: Telecom Bretagne
name: Campden BRI
name: EuroFIR
First posted: 2016-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Patients' subjective assessment of usability of the PRECIOUS system
timeFrame: At the end of the test (Session 5, week 12)
measure: Satisfaction with the PRECIOUS system
timeFrame: At the end of the test (Session 5, week 12)
measure: User's acceptance of the PRECIOUS system
timeFrame: At the end of the test (Session 5, week 12)
measure: Effectiveness of the PRECIOUS system
timeFrame: At the end of the test (Session 5, week 12)
Secondary outcomes:
measure: Demographics and clinical data
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Health-related quality of life
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Weight management
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Severity of the core symptoms of Depression, Anxiety & Stress
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Physical activity
timeFrame: Continuous measure (intervention groups)
measure: Nutritional habits
timeFrame: Continuous measure (intervention groups)
measure: Alcohol consumption
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Tobacco use
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Sleep quality
timeFrame: Session 1 (week 1) and Session 5 (week 12)
measure: Assessment of the motivational aspects of PRECIOUS
timeFrame: Session 5 (week 12) Intervention groups
measure: Bodyguard 2 device
timeFrame: Session 1 (week 1) and Session 5 (week 12)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry
Study officials:
affiliation: Aalto University
name: Jose Costa Requena, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry
name: Pilar Lusilla Palacios, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castellano-Tejedor C, Moreno J, Ciudin A, Parramon G, Lusilla-Palacios P. PREventive Care Infrastructure based On Ubiquitous Sensing (PRECIOUS): A Study Protocol. JMIR Res Protoc. 2017 May 31;6(5):e105. doi: 10.2196/resprot.6973.