Smartphone Application for Weight Loss
OBSBIT
Efficacy of a Mobile Application for Weight Loss in Overweight and Obese Adults: A Randomized Controlled Trial
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedApril 15, 2015
April 1, 2015
2 years
March 26, 2015
April 14, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (5)
Physical activity measured with two brief validated questionnaires
12 months
glucemic levels
12 months
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
12 months
blood pressure
12 months
GPT levels
12 months
Study Arms (2)
Smartphone intervention group
EXPERIMENTALThe experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.
Control group
NO INTERVENTIONControl group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline
Interventions
Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary Health Care La Granja- Torreforta
Tarragona, 43006, Spain
Related Publications (1)
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.
PMID: 26041131DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 15, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
April 15, 2015
Record last verified: 2015-04