Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control Group (CG)
Moderate physical activity group (MPA)
Intense physical activity group (IPA)
Sponsored by
About this trial
This is an interventional other trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- Having a IMC >25,
- Being sedentary and
- Have not been submitted to a restrictive diet in the 6 months preceding this study.
- Having a body fat percentage of ≥ 30%
Exclusion Criteria:
- Suffered from type 2 diabetes or renal conditions
- Being pregnancy or attempt at pregnancy,
- Being in a maternal lactation period,
- Not possessing a Smartphone with an operating system (Android or iOS) and available data connection did not participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control Group (CG)
Moderate physical activity group (MPA)
Intense physical activity group (IPA)
Arm Description
Education, modifying diet and light physical activity (LPA)
Education, modifying diet and moderate physical activity (MPA)
Education, modifying diet and intense physical activity (IPA)
Outcomes
Primary Outcome Measures
Changes from baseline BMI
Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale
Changes from baseline Fatty mass
Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Free-fatty mass
Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Changes from baseline Muscular Mass
Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Changes from baseline Corporal Water
Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Adherence to dietary pattern will be also measured through personal interview
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03911583
Brief Title
Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women
Official Title
Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women. Protocol of a Three-armed Clinical Assay
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A clinical three-armed assay has been established to permit an evaluation of the effectiveness of implementing PUSH notifications in the actions orientated towards improving body composition through the establishment of dietary patterns and an increase in physical activity.
Detailed Description
The use of mobile technology is already part of the investigator's daily life and its presence is increasing exponentially. The term mHealth (mobile health) was used and defined for the first time in 2000. This concept was subsequently employed in the 2010 mHealth Summit of the Foundation for National Institutes of Health (FNIH) to refer to "the provision of medical attention services through mobile communication devices". Around 40% of the over 300,000 applications available in the different apps stores are related to health themes, with those focused on the monitoring and management of diseases standing out. One of the characteristics of mobile applications is the sending and receiving of messages through a system of notifications known as "PUSH", that consists of requests appearing on the display of the Smartphone at a scheduled time, permitting them to be customizable both in their contents and at the time of sending them
PUSH notifications are pro-active as they offer visual and/or aural alerts to inform the recipient of a message or event received and invite them to act on them, even without the App being in use. On receiving the notification, the user can interact in different degrees, from simply reading it to answering it, thus permitting feedback. Also, there is evidence of the PUSH notifications being effective in communications between professionals.
The objective of this study is to compare the effect of the implementation of a monitoring system, goal to achieve, on physical activity in overweight and obese adults. A clinical three-armed assay has been established to permit an evaluation of the effectiveness of implementing PUSH notifications in the actions orientated towards improving body composition through the establishment of dietary patterns and an increase in physical activity.
Participants (n=90) will be recruited through outpatient from private clinics in Cádiz, Andalucía, Spain, as well as through community presentations. Overweight or obese and sedentary adult will be randomly assigned into three groups.
For 6 months, all of the adults shall follow the same diet with an identical distribution of macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass for all of them. The status of the number of steps in Accupedo is also checked every week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CG)
Arm Type
Active Comparator
Arm Description
Education, modifying diet and light physical activity (LPA)
Arm Title
Moderate physical activity group (MPA)
Arm Type
Active Comparator
Arm Description
Education, modifying diet and moderate physical activity (MPA)
Arm Title
Intense physical activity group (IPA)
Arm Type
Active Comparator
Arm Description
Education, modifying diet and intense physical activity (IPA)
Intervention Type
Behavioral
Intervention Name(s)
Control Group (CG)
Intervention Description
The control group does not receive these notifications (PUSH)
Intervention Type
Behavioral
Intervention Name(s)
Moderate physical activity group (MPA)
Intervention Description
The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.
Intervention Type
Behavioral
Intervention Name(s)
Intense physical activity group (IPA)
Intervention Description
The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.
Primary Outcome Measure Information:
Title
Changes from baseline BMI
Description
Baseline mean BMI values will be measured and compared at 3, 6, 12 and 24 months. BMI will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Fatty mass
Description
Baseline mean Fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Free-fatty mass
Description
Baseline mean Free-fatty mass values will be measured and compared at 3, 6, 12 and 24 months. Free-fatty mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a percentage.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Muscular Mass
Description
Baseline mean Muscular Mass values will be measured and compared at 3, 6, 12 and 24 months. Muscular Mass will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Changes from baseline Corporal Water
Description
Baseline mean Corporal Water values will be measured and compared at 3, 6, 12 and 24 months. Corporal Water will be assessed on a monthly basis during nutritional consultation through a Bioelectrical Impedance Analysis method using a Tanita BC-418 Segmental Body Composition Analyser/Scale. Fatty mass is measured as a Kg.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to dietary pattern will be also measured through personal interview
Description
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in dietary patterns will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Time Frame
At baseline (0 years) and followed for 2 years
Title
Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)
Description
Participants will be subjected for an intervention based on nutritional (control group) and physical education (two intervention arms) during 24 months. Partial measures will be also taken every week. In the end of the trial, changes in physical activity will be measured comparing means differences between baselines, 3, 6, 12 and 24 months.
Time Frame
At baseline (0 years) and followed for 2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Having a IMC >25,
Being sedentary and
Have not been submitted to a restrictive diet in the 6 months preceding this study.
Having a body fat percentage of ≥ 30%
Exclusion Criteria:
Suffered from type 2 diabetes or renal conditions
Being pregnancy or attempt at pregnancy,
Being in a maternal lactation period,
Not possessing a Smartphone with an operating system (Android or iOS) and available data connection did not participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Hernández-Reyes, M.Sc.
Organizational Affiliation
Universidad de Córdoba
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32093701
Citation
Hernandez-Reyes A, Molina-Recio G, Molina-Luque R, Romero-Saldana M, Camara-Martos F, Moreno-Rojas R. Effectiveness of PUSH notifications from a mobile app for improving the body composition of overweight or obese women: a protocol of a three-armed randomized controlled trial. BMC Med Inform Decis Mak. 2020 Feb 24;20(1):40. doi: 10.1186/s12911-020-1058-7.
Results Reference
derived
PubMed Identifier
32049065
Citation
Hernandez-Reyes A, Camara-Martos F, Molina Recio G, Molina-Luque R, Romero-Saldana M, Moreno Rojas R. Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e13747. doi: 10.2196/13747.
Results Reference
derived
Learn more about this trial
Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women
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