Smartphone Application for Weight Loss (OBSBIT)

April 14, 2015 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Tarragona, Spain, 43006
        • Recruiting
        • Primary Health Care La Granja- Torreforta
        • Contact:
        • Sub-Investigator:
          • Mar Sorlí, Bsc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone intervention group
The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.
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
No Intervention: Control group
Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight (Kg)
Time Frame: 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.
12 months
Body mass index (Kg/m2)
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity measured with two brief validated questionnaires
Time Frame: 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).
12 months
glucemic levels
Time Frame: 12 months
To improve the glucose levels
12 months
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
Time Frame: 12 months
To improve the profile of cholesterol.
12 months
blood pressure
Time Frame: 12 months
To improve the blood pressure
12 months
GPT levels
Time Frame: 12 months
To monitorize GPT levels
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/07 IDIAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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