Study Results
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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UNKNOWN
NA
76 participants
INTERVENTIONAL
2015-01-31
2017-01-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
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
Control group
Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
40 Years
ALL
Yes
Sponsors
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Locations
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Primary Health Care La Granja- Torreforta
Tarragona, , Spain
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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2013/07 IDIAP
Identifier Type: -
Identifier Source: org_study_id
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