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Smartphone Application for Weight Loss (OBSBIT)

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Smartphone Application group
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Primary Health Care La Granja- TorrefortaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone intervention group

Control group

Arm Description

The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.

Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
glucemic levels
To improve the glucose levels
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
To improve the profile of cholesterol.
blood pressure
To improve the blood pressure
GPT levels
To monitorize GPT levels

Full Information

First Posted
March 26, 2015
Last Updated
April 14, 2015
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT02417623
Brief Title
Smartphone Application for Weight Loss
Acronym
OBSBIT
Official Title
Efficacy of a Mobile Application for Weight Loss in Overweight and Obese Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone intervention group
Arm Type
Experimental
Arm Description
The experimental group will receive the standard diet intervention for weight loss plus free Smartphone app plus a wearable device.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline
Intervention Type
Behavioral
Intervention Name(s)
Smartphone Application group
Intervention Description
Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app
Primary Outcome Measure Information:
Title
Body weight (Kg)
Description
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.
Time Frame
12 months
Title
Body mass index (Kg/m2)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical activity measured with two brief validated questionnaires
Description
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).
Time Frame
12 months
Title
glucemic levels
Description
To improve the glucose levels
Time Frame
12 months
Title
cholesterol profile (LDL-cholesterol, HDL-Cholesterol, Cholesterol total)
Description
To improve the profile of cholesterol.
Time Frame
12 months
Title
blood pressure
Description
To improve the blood pressure
Time Frame
12 months
Title
GPT levels
Description
To monitorize GPT levels
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gemma Flores-Mateo, PhD
Phone
+34977778515
Email
gflores@idiapjgol.org
Facility Information:
Facility Name
Primary Health Care La Granja- Torreforta
City
Tarragona
ZIP/Postal Code
43006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Flores Mateo, PhD
Phone
0034977778515
Email
gflores@idiapjgol.org
First Name & Middle Initial & Last Name & Degree
Mar Sorlí, Bsc

12. IPD Sharing Statement

Citations:
PubMed Identifier
26041131
Citation
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.
Results Reference
derived

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Smartphone Application for Weight Loss

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