Clinical trial NCT03911583: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes from baseline BMI
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Fatty mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Free-fatty mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Muscular Mass
timeFrame: At baseline (0 years) and followed for 2 years
measure: Changes from baseline Corporal Water
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to dietary pattern will be also measured through personal interview
timeFrame: At baseline (0 years) and followed for 2 years
measure: Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire)
timeFrame: At baseline (0 years) and followed for 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Córdoba
name: Alberto Hernández-Reyes, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.