CClinicalTrials.gg
Status unknownNCT02417623OBSBITUpdated Apr 15, 2015

Smartphone Application for Weight Loss

An interventional study of Smartphone Application group in Obesity, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

AIM: To assess the efficacy of an intervention that includes the assistance of a weight loss smartphone application targeted to young people aged 18 to 40 years.

DESIGN: Randomisedclinical trial.

SETTING: Primary Health Care centres (PHCCs) in Catalonia.

PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting PHCCs for any reason and who provide written informed consent to participate in the trial.

INTERVENTION GROUP will receive a 12-month weight loss programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme.

CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12 months.

EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group than in control group.

Read the detailed description

DESIGN: Randomised clinical trial.

SETTING: Primary Health Care centres (PHCCs) in Catalonia, Spain.

PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting PHCCs for any reason and who provide written informed consent to participate in the trial.

INTERVENTION GROUP will receive a 12-month weight loss programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme.

CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12 months.

EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group than in control group.

02

Conditions studied

  • Obesity

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03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's planned enrollment of 76 is close to the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Young adults aged 18 to 40 years with overweight or obesity
  • availability of the patient's clinical history in the primary care centre
  • access to a smartphone device that meets the app requirements
  • access to an Internet data connection

Exclusion criteria

Exclusion Criteria:

  • Morbid obesity with BMI> 40
  • Secondary Obesity (eg endocrine pathology)
  • eating disorders (the patient or any member of the family);
  • Presence of any significant comorbidity that a specific treatment (type 1 diabetes mellitus, severe mental illness);
  • pregnant or desire pregnancy in the next 12 months;
  • To participate in a weight loss program or taking any medication for weight loss in the moment of the recruitment
  • Take any medication that may influence body weight;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Smartphone intervention group

    The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.

    Behavioral: Smartphone Application group

  • No intervention
    Control group

    Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline

Interventions

  • BehavioralSmartphone Application group

    Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app

06

What researchers measure

Primary outcomes

  1. Body weight (Kg)

    Change in body weight at 12 months in the experimental group, compared with the control group. At each study visit, anthropometrics will be recorded by a primary care nurse or doctor. Body weight will be measured with the participant dressed in light clothing with shoes off on a calibrated balance.

    Time frame: 12 months

  2. Body mass index (Kg/m2)

    change in body mass index at 12 months in the experimental group, compared with the control group.. At each study visit, anthropometrics will be recorded by a primary care nurse or doctor. Body weight will be measured with the participant dressed in light clothing with shoes off on a calibrated balance.

    Time frame: 12 months

Secondary outcomes

  1. Physical activity measured with two brief validated questionnaires

    To increase physical activity at 12 months. Physical activity will be measured with two brief validated questionnaires, administered in the participant's preferred language (Catalan or Spanish).

    Time frame: 12 months

  2. glucemic levels

    To improve the glucose levels

    Time frame: 12 months

  3. cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)

    To improve the profile of cholesterol.

    Time frame: 12 months

  4. blood pressure

    To improve the blood pressure

    Time frame: 12 months

  5. GPT levels

    To monitorize GPT levels

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Primary Health Care La Granja- Torreforta
    Tarragona, 43006, Spain
    • Gemma Flores Mateo, PhD · Contact · gflores@idiapjgol.org · 0034977778515
    • Mar Sorlí, Bsc · Sub investigator
    Recruiting
08

References and documents

Publications

  • Granado-Font E, Flores-Mateo G, Sorli-Aguilar M, Montana-Carreras X, Ferre-Grau C, Barrera-Uriarte ML, Oriol-Colominas E, Rey-Renones C, Caules I, Satue-Gracia EM; OBSBIT Study Group. Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial. BMC Public Health. 2015 Jun 4;15:531. doi: 10.1186/s12889-015-1845-8. PubMed 26041131 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02417623
Lead sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible party
Sponsor
First posted
Apr 15, 2015
Start date
Jan 2015
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Apr 15, 2015

Study contacts

Gemma Flores-Mateo, PhD
Contact
gflores@idiapjgol.org
+34977778515

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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