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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone intervention group | Experimental | The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device. |
|
| Control group | No Intervention | Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone Application group | Behavioral | Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| glucemic levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gemma Flores-Mateo, PhD | Contact | +34977778515 | gflores@idiapjgol.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care La Granja- Torreforta | Recruiting | Tarragona | 43006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26041131 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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To improve the glucose levels |
| 12 months |
| cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total) | To improve the profile of cholesterol. | 12 months |
| blood pressure | To improve the blood pressure | 12 months |
| GPT levels | To monitorize GPT levels | 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |