ObesityOBSBITNCT02417623
Smartphone Application for Weight Loss
A study testing Smartphone Application group in people with Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Smartphone Application group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Primary Health Care La Granja- Torreforta
Tarragona, 43006
Gemma Flores Mateo, PhD, 0034977778515, gflores@idiapjgol.org
Mar Sorlí, Bsc
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Smartphone Application group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Application groupBehavioural
Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app
| Study group | Role | What they receive |
|---|---|---|
| Smartphone intervention group | Experimental | The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device. Receives: Behavioral: Smartphone Application group |
| Control group | No intervention | Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (5)
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).
Measured: 12 months
glucemic levels
To improve the glucose levels
Measured: 12 months
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
To improve the profile of cholesterol.
Measured: 12 months
blood pressure
To improve the blood pressure
Measured: 12 months
GPT levels
To monitorize GPT levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417623
- Sponsor's protocol ID
- 2013/07 IDIAP
- Acronym
- OBSBIT
- Status last verified
- Apr 2015
- First submitted
- 26 Mar 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26041131
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mobile Application for Weight Loss in Overweight and Obese Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02417623
- Acronym / sponsor ID
- OBSBIT / 2013/07 IDIAP
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone intervention group | Experimental | Behavioral: Smartphone Application groupThe experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device. |
| Control group | No intervention | –Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Application groupIntervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app | Behavioural | Smartphone intervention group |
Primary outcome
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.
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.
5 secondary outcomes
Physical activity measured with two brief validated questionnaires
Time frame: 12 months
glucemic levels
Time frame: 12 months
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
Time frame: 12 months
blood pressure
Time frame: 12 months
GPT levels
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Derived from this study: PubMed 26041131Granado-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application group in people with Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gemma Flores-Mateo, PhD (+34977778515, gflores@idiapjgol.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (Kg) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.