Effectiveness of PUSH Notifications From a Mobile App for Improving the Body Composition of Overweight or Obese Women

Study Overview
=================
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.

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

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Control Group (CG)
* Behavioral: Moderate physical activity group (MPA)
* Behavioral: Intense physical activity group (IPA)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (CG)<br>Education, modifying diet and light physical activity (LPA) | Behavioral: Control Group (CG)<br>* The control group does not receive these notifications (PUSH)<br>|
| Active Comparator: Moderate physical activity group (MPA)<br>Education, modifying diet and moderate physical activity (MPA) | Behavioral: Moderate physical activity group (MPA)<br>* The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.<br>|
| Active Comparator: Intense physical activity group (IPA)<br>Education, modifying diet and intense physical activity (IPA) | Behavioral: Intense physical activity group (IPA)<br>* The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At baseline (0 years) and followed for 2 years | 
| 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. | At baseline (0 years) and followed for 2 years | 
| 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. | At baseline (0 years) and followed for 2 years | 
| 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. | At baseline (0 years) and followed for 2 years | 
| 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. | At baseline (0 years) and followed for 2 years | 
| 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. | At baseline (0 years) and followed for 2 years | 
| 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. | At baseline (0 years) and followed for 2 years |