Smartphone Application for Weight Loss

Study Overview
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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.

Official Title
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Efficacy of a Mobile Application for Weight Loss in Overweight and Obese Adults: A Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Smartphone Application group


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone intervention group<br>The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device. | Behavioral: Smartphone Application group<br>* Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app<br>|
| No Intervention: Control group<br>Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |