- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818790
PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS). VHIR Pilot. (PRECIOUS)
PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group 1. Control
|
|
Experimental: Group 2. Intervention 1
|
Bodyguard + Precious App.
Short onsite training session on how to use the system.
|
Experimental: Group 2. Intervention 2
|
Bodyguard + Precious App + Motivational Interviewing.
Face to face counseling session followed by a short onsite training session on how to use the system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' subjective assessment of usability of the PRECIOUS system
Time Frame: At the end of the test (Session 5, week 12)
|
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
Time Frame: At the end of the test (Session 5, week 12)
|
o 16 Numeric scales 0-10
|
At the end of the test (Session 5, week 12)
|
User's acceptance of the PRECIOUS system
Time Frame: At the end of the test (Session 5, week 12)
|
o 4 Numeric scales 0-10, based on QUIS7
|
At the end of the test (Session 5, week 12)
|
Effectiveness of the PRECIOUS system
Time Frame: At the end of the test (Session 5, week 12)
|
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
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
o Ad hoc protocol (17 items)
|
Session 1 (week 1) and Session 5 (week 12)
|
Health-related quality of life
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
o SF12v2: 12 items
|
Session 1 (week 1) and Session 5 (week 12)
|
Weight management
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
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
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
o DASS (21 items)
|
Session 1 (week 1) and Session 5 (week 12)
|
Physical activity
Time Frame: Continuous measure (intervention groups)
|
o Data provided by the app
|
Continuous measure (intervention groups)
|
Nutritional habits
Time Frame: Continuous measure (intervention groups)
|
o Data provided by the app
|
Continuous measure (intervention groups)
|
Alcohol consumption
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
o Audit (10 items)
|
Session 1 (week 1) and Session 5 (week 12)
|
Tobacco use
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
o Fagerström (6 items)
|
Session 1 (week 1) and Session 5 (week 12)
|
Sleep quality
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
o Pittsburg Quality of Sleep index (18 items)
|
Session 1 (week 1) and Session 5 (week 12)
|
Assessment of the motivational aspects of PRECIOUS
Time Frame: Session 5 (week 12) Intervention groups
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o 23 numeric scales 0-10
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Session 5 (week 12) Intervention groups
|
Bodyguard 2 device
Time Frame: Session 1 (week 1) and Session 5 (week 12)
|
Heart Rate Variability measurement
|
Session 1 (week 1) and Session 5 (week 12)
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jose Costa Requena, PhD, Aalto University
- Principal Investigator: Pilar Lusilla Palacios, PhD, MD, Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRECIOUS_VHIR_Pilot (611366)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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