Smartphone Application for Weight Loss
- Conditions
- Obesity
- Interventions
- Behavioral: Smartphone Application group
- Registration Number
- NCT02417623
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 76
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Smartphone intervention group Smartphone Application group The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.
- Primary Outcome Measures
Name Time Method Body mass index (Kg/m2) 12 months 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.
Body weight (Kg) 12 months 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.
- Secondary Outcome Measures
Name Time Method Physical activity measured with two brief validated questionnaires 12 months 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).
glucemic levels 12 months To improve the glucose levels
GPT levels 12 months To monitorize GPT levels
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total) 12 months To improve the profile of cholesterol.
blood pressure 12 months To improve the blood pressure
Trial Locations
- Locations (1)
Primary Health Care La Granja- Torreforta
🇪🇸Tarragona, Spain