Smartphone Application for Weight Loss

NCT ID: NCT02417623

Last Updated: 2015-04-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Smartphone intervention group

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

Group Type EXPERIMENTAL

Smartphone Application group

Intervention Type BEHAVIORAL

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smartphone 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Primary Health Care La Granja- Torreforta

Tarragona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Gemma Flores-Mateo, PhD

Role: CONTACT

+34977778515

Facility Contacts

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Gemma Flores Mateo, PhD

Role: primary

0034977778515

References

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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.

Reference Type DERIVED
PMID: 26041131 (View on PubMed)

Other Identifiers

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2013/07 IDIAP

Identifier Type: -

Identifier Source: org_study_id

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