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

NCT02818790 | Completed

• 1 other identifier: PRECIOUS_VHIR_Pilot (611366)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

mHealth; Motivational Interviewing; Obesity; Prevention; Diet; Physical Activity; Health Preventive System

Outcome Measures

Primary Outcomes (4)

• Patients' subjective assessment of usability of the PRECIOUS system

  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

  o 16 Numeric scales 0-10

  At the end of the test (Session 5, week 12)

• User's acceptance of the PRECIOUS system

  o 4 Numeric scales 0-10, based on QUIS7

  At the end of the test (Session 5, week 12)

• Effectiveness of the PRECIOUS system

  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 Outcomes (11)

• Demographics and clinical data

  Session 1 (week 1) and Session 5 (week 12)

• Health-related quality of life

  Session 1 (week 1) and Session 5 (week 12)

• Weight management

  Session 1 (week 1) and Session 5 (week 12)

• Severity of the core symptoms of Depression, Anxiety & Stress

  Session 1 (week 1) and Session 5 (week 12)

• Physical activity

  Continuous measure (intervention groups)

Study Arms (3)

Group 1. Control

NO INTERVENTION

Group 2. Intervention 1

EXPERIMENTAL

Behavioral: Intervention 1

Group 2. Intervention 2

EXPERIMENTAL

Behavioral: Intervention 2

Interventions

Intervention 1 BEHAVIORAL

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

Group 2. Intervention 1

Intervention 2 BEHAVIORAL

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

Group 2. Intervention 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Aalto University: collaborator
• University of Helsinki: collaborator
• Firstbeat Technologies Ltd.: collaborator
• University of Vienna: collaborator
• Telecom Bretagne: collaborator
• Campden BRI: collaborator
• EuroFIR: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry

Barcelona, 08035, Spain

Location

Related Publications (2)

• Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  PMID: 38375882 DERIVED

• 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.

  PMID: 28566263 DERIVED

Related Links

• Link of full list of publications of the consortium of the PRECIOUS Project

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jose Costa Requena, PhD

  Aalto University

  STUDY CHAIR

• Pilar Lusilla Palacios, PhD, MD

  Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron. Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 30, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

ES (1)