Overview

This trial is active, not recruiting.

Condition obesity
Treatments intervention 1, intervention 2
Sponsor Hospital Universitari Vall d'Hebron Research Institute
Collaborator Aalto University
Start date May 2016
End date July 2016
Trial size 30 participants
Trial identifier NCT02818790, PRECIOUS_VHIR_Pilot (611366)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(No Intervention)
(Experimental)
intervention 1
Bodyguard + Precious App. Short onsite training session on how to use the system.
(Experimental)
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.

Primary Outcomes

Measure
Patients' subjective assessment of usability of the PRECIOUS system
time frame: 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)
User's acceptance of the PRECIOUS system
time frame: 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)

Secondary Outcomes

Measure
Demographics and clinical data
time frame: 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)
Weight management
time frame: 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)
Physical activity
time frame: Continuous measure (intervention groups)
Nutritional habits
time frame: Continuous measure (intervention groups)
Alcohol consumption
time frame: Session 1 (week 1) and Session 5 (week 12)
Tobacco use
time frame: Session 1 (week 1) and Session 5 (week 12)
Sleep quality
time frame: Session 1 (week 1) and Session 5 (week 12)
Assessment of the motivational aspects of PRECIOUS
time frame: Session 5 (week 12) Intervention groups
Bodyguard 2 device
time frame: Session 1 (week 1) and Session 5 (week 12)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)
Principal investigator Pilar Lusilla Palacios, PhD, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hospital Universitari Vall d'Hebron Research Institute.