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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
Universidad de Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    April 9, 2019
    Last Updated
    April 10, 2019
    Sponsor
    Universidad de Córdoba
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    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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