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

NCT03911583 | Unknown

• 1 other identifier: V2-A284R4156
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Control Group (CG)

ACTIVE COMPARATOR

Education, modifying diet and light physical activity (LPA)

Behavioral: Control Group (CG)

Moderate physical activity group (MPA)

ACTIVE COMPARATOR

Education, modifying diet and moderate physical activity (MPA)

Behavioral: Moderate physical activity group (MPA)

Intense physical activity group (IPA)

ACTIVE COMPARATOR

Education, modifying diet and intense physical activity (IPA)

Behavioral: Intense physical activity group (IPA)

Interventions

Control Group (CG) BEHAVIORAL

The control group does not receive these notifications (PUSH)

Control Group (CG)

Moderate physical activity group (MPA) BEHAVIORAL

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

Moderate physical activity group (MPA)

Intense physical activity group (IPA) 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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Córdoba: lead

Related Publications (2)

• 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.

  PMID: 32093701 DERIVED

• 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.

  PMID: 32049065 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Alberto Hernández-Reyes, M.Sc.

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: January 1, 2016
• Primary Completion: December 15, 2018
• Study Completion: June 1, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share