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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • 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 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

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
Intervention / Treatment
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

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

Universiti Sains Malaysia

Collaborators

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)

December 1, 2023

Primary Completion (Actual)

March 10, 2024

Study Completion (Actual)

May 10, 2024

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Childhood Obesity

Clinical Trials on Smart Phone Education (mhealth)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe