Effect of Smart Phone Health Education on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition (mHealth)

May 11, 2024 updated by: Heba Mustafaalsaafin, Universiti Sains Malaysia

Effect of Smart Phone Delivered Health Education Intervention on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition in the UAE

The aim of this study is to investigate the effect of mobile health nutrition education intervention in the changing of dietary habits and body composition of overweight and obese 8-12 years old children in Sharjah, United Arab Emirates and to compare its effectiveness to paper educational intervention among the same age group.

The main questions it aims to answer are:

  1. Are there any significant changes in dietary habits, physical activity and body composition among overweight and obese school-age children after three months of mobile health intervention?
  2. Is there any significant difference between the effect of smart phone delivered and paper delivered interventions (changes in dietary habits, physical activity and body composition) among overweight and obese school-age children after three months of interventions?
  3. Are there any significant changes in the obesity inflammatory panel among overweight and obese school-age children after three months of mobile health intervention?
  4. Is there any significant difference in the sustainability of the outcomes between mobile health and paper delivered interventions among overweight and obese school-age children two months after the end of the intervention?
  5. Are there any significant changes in nutrition related knowledge among parents of overweight and obese school-age children after three months of intervention?

Participants (children with their parents) will be randomly divided into intervention group and control group. Parents of children from the intervention group will receive two text messages/graphics per week about healthy eating and physical activity (PA) on their mobile phones during the intervention period (3 months). While parents in the control group will receive a one-time printed handout containing the same messages at the beginning of the intervention period.

Assessment of children's anthropometry, dietary intake and physical activity will be evaluated pre and post intervention and one more time after a two months period of maintenance after the end of the intervention. Parents' nutrition knowledge will be evaluated pre and post intervention only. Also, children salivary obesity markers will be measured at baseline and at the end of the intervention period to explore the effects of the intervention on inflammatory markers associated with obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).
  • Between 8 - 12 years old.
  • Attending school in Sharjah, UAE.

Exclusion Criteria:

  • Children on a specific diet.
  • Children who have any chronic diseases.

Parents qualify if their children meet the inclusion criteria, they can read and speak in Arabic, they plan to stay in Sharjah for six months from the beginning of the intervention, and they own and use a smart phone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Participants in the intervention group will receive smart phone delivered health education in the form of text messages through WhatsApp.
Other: Smart Phone Education (mhealth)
Nutrition and Health Education module delivered through m-health approach (smart phones)
Active Comparator: Control group
Participants in the control group will receive paper delivered health education in the form of a one time handout.
Other: Paper Education (conventional)
Nutrition and Health Education module delivered through conventional approach (paper)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Height
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Will be measured using a standing Stadiometer, and will be measured in Centimetres
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Body Mass Index
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Will be calculated using the weight and height, and will be measured in kg/m^2
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Body Fat Mass
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Fat Free Mass
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Total Body Water
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Parents' Knowledge
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Using a valid Nutrition Knowledge Attitude Practice Questionnaire - no scale
twice: before intervention (at 0 months) and after intervention (at 3 months).
Children's Dietary Intake
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Using 24 Hours' Diet recall (3 days).
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Children's Physical Activity
Time Frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Using a valid Physical Activity Questionnaire - no scale
3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Salivary C-Reactive Protein Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Adiponectin (Acrp30) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Complement Factor D (Adipsin) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Interleukin 6 (IL-6) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Interleukin 10 (IL-10) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Leptin (OB) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Resistin Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Plasminogen Activator Inhibitor-1 (Serpin E1 / PAI-1) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Tumour Necrosis Factor alpha (TNF alpha) Concentration
Time Frame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
twice: before intervention (at 0 months) and after intervention (at 3 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USM/JEPeM/KK/23020205
  • REC-22-09-05-01 (Other Identifier: University of Sharjah)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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