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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03911583
• Other study ID #: V2-A284R4156
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2019
• Source: Universidad de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 1, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Control Group (CG)
The control group does not receive these notifications (PUSH)
• Moderate physical activity group (MPA)
The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.
• Intense physical activity group (IPA)
The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Córdoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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