Clinical trial NCT02417623: Smartphone Application for Weight Loss
Official title: Efficacy of a Mobile Application for Weight Loss in Overweight and Obese Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Body weight (Kg)
timeFrame: 12 months
measure: Body mass index (Kg/m2)
timeFrame: 12 months
Secondary outcomes:
measure: Physical activity measured with two brief validated questionnaires
timeFrame: 12 months
measure: glucemic levels
timeFrame: 12 months
measure: cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
timeFrame: 12 months
measure: blood pressure
timeFrame: 12 months
measure: GPT levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Tarragona
country: Spain
facility: Primary Health Care La Granja- Torreforta
Study officials:
References:
citation: 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.