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ObesityPRECIOUSNCT02818790

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

A study testing Intervention 1 and Intervention 2 in people with Obesity, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Intervention 1 and Intervention 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
May 2016to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Barcelona, 08035

Other trials in Spain

About this study

Official title: PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)

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.

Read the 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).

Conditions
Obesity
Being tested
Intervention 1, Intervention 2
Keywords
mHealth, Motivational Interviewing, Obesity, Prevention, Diet, Physical Activity, Health Preventive System
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention 1Behavioural

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

  • Intervention 2Behavioural

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

Study groups in NCT02818790
Study groupRoleWhat they receive
Group 1. ControlNo interventionNot described
Group 2. Intervention 1ExperimentalNot described
Receives: Behavioral: Intervention 1
Group 2. Intervention 2ExperimentalNot described
Receives: Behavioral: Intervention 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients' subjective assessment of usability of the PRECIOUS system

    • Numeric scale 0-10 \& 10 items, 5-point Likert Scale, 0-100

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

  2. Satisfaction with the PRECIOUS system

    • 16 Numeric scales 0-10

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

  3. User's acceptance of the PRECIOUS system

    • 4 Numeric scales 0-10, based on QUIS7

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

  4. Effectiveness of the PRECIOUS system

    • 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.

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

Secondary outcomes (11)

  1. Demographics and clinical data

    • Ad hoc protocol (17 items)

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

  2. Health-related quality of life

    • SF12v2: 12 items

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

  3. Weight management

    • S-Weight (5 items) \& P-Weight (34 items)

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

  4. Severity of the core symptoms of Depression, Anxiety & Stress

    • DASS (21 items)

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

  5. Physical activity

    • Data provided by the app

    Measured: Continuous measure (intervention groups)

  6. Nutritional habits

    • Data provided by the app

    Measured: Continuous measure (intervention groups)

  7. Alcohol consumption

    • Audit (10 items)

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

  8. Tobacco use

    • Fagerström (6 items)

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

  9. Sleep quality

    • Pittsburg Quality of Sleep index (18 items)

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

  10. Assessment of the motivational aspects of PRECIOUS

    • 23 numeric scales 0-10

    Measured: Session 5 (week 12) Intervention groups

  11. Bodyguard 2 device

    Heart Rate Variability measurement

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJul 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818790
Sponsor's protocol ID
PRECIOUS_VHIR_Pilot (611366)
Acronym
PRECIOUS
Status last verified
May 2017
First submitted
16 Jun 2016
Last updated
22 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38375882

  • 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.

    PubMed 28566263

Questions about this trial

What is this clinical trial studying?

A study testing Intervention 1 and Intervention 2 in people with Obesity, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' subjective assessment of usability of the PRECIOUS system (time frame: At the end of the test (Session 5, week 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02818790, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.

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