Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry
Barcelona, 08035, Spain
NCT Number: NCT02818790
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bodyguard + Precious App. Short onsite training session on how to use the system.
Bodyguard + Precious App + Motivational Interviewing. Face to face counseling session followed by a short onsite training session on how to use the 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
Time frame: At the end of the test (Session 5, week 12)
o 16 Numeric scales 0-10
Time frame: At the end of the test (Session 5, week 12)
o 4 Numeric scales 0-10, based on QUIS7
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.
Time frame: Session 1 (week 1) and Session 5 (week 12)
o Ad hoc protocol (17 items)
Time frame: Session 1 (week 1) and Session 5 (week 12)
o SF12v2: 12 items
Time frame: Session 1 (week 1) and Session 5 (week 12)
o S-Weight (5 items) & P-Weight (34 items)
Time frame: Session 1 (week 1) and Session 5 (week 12)
o DASS (21 items)
Time frame: Continuous measure (intervention groups)
o Data provided by the app
Time frame: Continuous measure (intervention groups)
o Data provided by the app
Time frame: Session 1 (week 1) and Session 5 (week 12)
o Audit (10 items)
Time frame: Session 1 (week 1) and Session 5 (week 12)
o Fagerström (6 items)
Time frame: Session 1 (week 1) and Session 5 (week 12)
o Pittsburg Quality of Sleep index (18 items)
Time frame: Session 5 (week 12) Intervention groups
o 23 numeric scales 0-10
Time frame: Session 1 (week 1) and Session 5 (week 12)
Heart Rate Variability measurement
Hospital Universitari Vall d'Hebron Research Institute
Other
PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)
Acronym: PRECIOUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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