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

NCT ID: NCT03911583

Last Updated: 2019-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-06-01

Brief Summary

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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

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group (CG)

Education, modifying diet and light physical activity (LPA)

Group Type ACTIVE_COMPARATOR

Control Group (CG)

Intervention Type BEHAVIORAL

The control group does not receive these notifications (PUSH)

Moderate physical activity group (MPA)

Education, modifying diet and moderate physical activity (MPA)

Group Type ACTIVE_COMPARATOR

Moderate physical activity group (MPA)

Intervention Type BEHAVIORAL

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)

Education, modifying diet and intense physical activity (IPA)

Group Type ACTIVE_COMPARATOR

Intense physical activity group (IPA)

Intervention Type BEHAVIORAL

The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.

Interventions

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Control Group (CG)

The control group does not receive these notifications (PUSH)

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Alberto Hernández de los Reyes

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Hernández-Reyes, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Córdoba

References

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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.

Reference Type DERIVED
PMID: 32093701 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32049065 (View on PubMed)

Other Identifiers

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V2-A284R4156

Identifier Type: -

Identifier Source: org_study_id

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