Obesity
Conditions
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.
Interventions
BEHAVIORALSmartphone 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
Sponsors
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total) | 12 months | To improve the profile of cholesterol. |
| 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). |
| GPT levels | 12 months | To monitorize GPT levels |
| blood pressure | 12 months | To improve the blood pressure |
| glucemic levels | 12 months | To improve the glucose levels |
Countries
Spain
Contacts
Primary ContactGemma Flores-Mateo, PhD
Outcome results
None listed