Childhood ObesitymHealthNCT06247202
Effect of Smart Phone Health Education on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition
A study testing Smart Phone Education (mhealth) and Paper Education (conventional) in people with Childhood Obesity, run by Universiti Sains Malaysia at 1 site in United Arab Emirates.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Smart Phone Education (mhealth) and Paper Education (conventional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Dec 2023to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).
- Between 8 - 12 years old.
- Attending school in Sharjah, UAE.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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?
- 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?
- Are there any significant changes in the obesity inflammatory panel among overweight and obese school-age children after three months of mobile health intervention?
- 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?
- 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.
- Conditions
- Childhood Obesity
- Being tested
- Smart Phone Education (mhealth), Paper Education (conventional)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Phone Education (mhealth)Other
Nutrition and Health Education module delivered through m-health approach (smart phones)
Paper Education (conventional)Other
Nutrition and Health Education module delivered through conventional approach (paper)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive smart phone delivered health education in the form of text messages through WhatsApp. Receives: Other: Smart Phone Education (mhealth) |
| Control group | Active comparator | Participants in the control group will receive paper delivered health education in the form of a one time handout. Receives: Other: Paper Education (conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Height
Will be measured using a standing Stadiometer, and will be measured in Centimetres
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Body Mass Index
Will be calculated using the weight and height, and will be measured in kg/m^2
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Body Fat Mass
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Fat Free Mass
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Total Body Water
Will be measured using a Body Composition Analyzer, and will be measured in Kilograms
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Parents' Knowledge
Using a valid Nutrition Knowledge Attitude Practice Questionnaire - no scale
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Children's Dietary Intake
Using 24 Hours' Diet recall (3 days).
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Children's Physical Activity
Using a valid Physical Activity Questionnaire - no scale
Measured: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Salivary C-Reactive Protein Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Adiponectin (Acrp30) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Complement Factor D (Adipsin) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Interleukin 6 (IL-6) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Interleukin 10 (IL-10) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Leptin (OB) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Resistin Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Plasminogen Activator Inhibitor-1 (Serpin E1 / PAI-1) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Salivary Tumour Necrosis Factor alpha (TNF alpha) Concentration
Concentration in saliva samples will be assessed using Luminex Performance Human Obesity Panel (10-Plex)
Measured: twice: before intervention (at 0 months) and after intervention (at 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Dec 2023
- Primary completion10 Mar 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly divided into intervention group and control group. intervention group will receive smart phone delivered nutrition education while control group will receive paper delivered nutrition education.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sharjah
- Responsible party
- Principal investigator, Heba Mustafaalsaafin, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247202
- Sponsor's protocol ID
- USM/JEPeM/KK/23020205
- Other IDs
- REC-22-09-05-01
- Acronym
- mHealth
- Status last verified
- May 2024
- First submitted
- 7 Jan 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smart Phone Delivered Health Education Intervention on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition in the UAE
- ClinicalTrials.gov ID
- NCT06247202
- Acronym / sponsor ID
- mHealth / USM/JEPeM/KK/23020205
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- University of Sharjah
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- Are there any significant changes in the obesity inflammatory panel among overweight and obese school-age children after three months of mobile health intervention?
- 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?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into intervention group and control group. intervention group will receive smart phone delivered nutrition education while control group will receive paper delivered nutrition education.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Smart Phone Education (mhealth)Participants in the intervention group will receive smart phone delivered health education in the form of text messages through WhatsApp. |
| Control group | Active comparator | Other: Paper Education (conventional)Participants in the control group will receive paper delivered health education in the form of a one time handout. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).
- Between 8 - 12 years old.
- Attending school in Sharjah, UAE.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Phone Education (mhealth)Nutrition and Health Education module delivered through m-health approach (smart phones) | Other | Intervention group |
| Paper Education (conventional)Nutrition and Health Education module delivered through conventional approach (paper) | Other | Control group |
Primary outcome
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
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
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
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
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
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
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
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).
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Phone Education (mhealth) and Paper Education (conventional) in people with Childhood Obesity, run by Universiti Sains Malaysia at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.