Smartphone Application for Weight Loss

Obesity Clinical Trial

— OBSBIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02417623
• Other study ID #: 2013/07 IDIAP
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2015
• Last updated: April 14, 2015
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2015
• Source: Jordi Gol i Gurina Foundation
• Contact: Gemma Flores-Mateo, PhD
• Phone: +34977778515
• Email: gflores[@]idiapjgol.org
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Smartphone 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

Locations

Country	Name	City	State
Spain	Primary Health Care La Granja- Torreforta	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	glucemic levels	To improve the glucose levels	12 months	No
Secondary	cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)	To improve the profile of cholesterol.	12 months	No
Secondary	blood pressure	To improve the blood pressure	12 months	No
Secondary	GPT levels	To monitorize GPT levels	12 months	No