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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-11-30

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.

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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).

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1. Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2. Intervention 1

Group Type EXPERIMENTAL

Intervention 1

Intervention Type BEHAVIORAL

Bodyguard + Precious App. Short onsite training session on how to use the system.

Group 2. Intervention 2

Group Type EXPERIMENTAL

Intervention 2

Intervention Type BEHAVIORAL

Bodyguard + Precious App + Motivational Interviewing. Face to face counseling session followed by a short onsite training session on how to use the system.

Interventions

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Intervention 1

Bodyguard + Precious App. Short onsite training session on how to use the system.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No