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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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