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

Childhood Obesity Clinical Trial

— mHealth  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247202
• Other study ID #: USM/JEPeM/KK/23020205
• Secondary ID: REC-22-09-05-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Universiti Sains Malaysia
• Contact: Heba Mustafaalsaafin
• Phone: +971509669174
• Email: heba.saafin[@]student.usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Overweight
• Pediatric Obesity

Intervention

Other:
• Smart Phone Education (mhealth)
Nutrition and Health Education module delivered through m-health approach (smart phones)
• Paper Education (conventional)
Nutrition and Health Education module delivered through conventional approach (paper)

Locations

Country	Name	City	State
United Arab Emirates	University of Sharjah	Sharjah

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	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)
Primary	Height	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)
Primary	Body Mass Index	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)
Primary	Body Fat Mass	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)
Primary	Fat Free Mass	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)
Primary	Total Body Water	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)
Primary	Parents' Knowledge	Using a valid Nutrition Knowledge Attitude Practice Questionnaire - no scale	twice: before intervention (at 0 months) and after intervention (at 3 months).
Primary	Children's Dietary Intake	Using 24 Hours' Diet recall (3 days).	3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Primary	Children's Physical Activity	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)
Primary	Salivary C-Reactive Protein Concentration	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).
Primary	Salivary Adiponectin (Acrp30) Concentration	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).
Primary	Salivary Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) Concentration	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).
Primary	Salivary Complement Factor D (Adipsin) Concentration	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).
Primary	Salivary Interleukin 6 (IL-6) Concentration	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).
Primary	Salivary Interleukin 10 (IL-10) Concentration	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).
Primary	Salivary Leptin (OB) Concentration	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).
Primary	Salivary Resistin Concentration	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).
Primary	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)	twice: before intervention (at 0 months) and after intervention (at 3 months).
Primary	Salivary Tumour Necrosis Factor alpha (TNF alpha) Concentration	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).