Clinical trial NCT06247202: Effect of Smart Phone Health Education on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition
Official title: Effect of Smart Phone Delivered Health Education Intervention on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition in the UAE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: University of Sharjah
First posted: 2024-02-07
Enrollment: 146
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Weight
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Height
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Body Mass Index
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Body Fat Mass
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Fat Free Mass
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Total Body Water
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Parents' Knowledge
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Children's Dietary Intake
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Children's Physical Activity
timeFrame: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
measure: Salivary C-Reactive Protein Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Adiponectin (Acrp30) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Monocyte Chemoattractant Protein-1 (MCP-1/CCL2) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Complement Factor D (Adipsin) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Interleukin 6 (IL-6) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Interleukin 10 (IL-10) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Leptin (OB) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Resistin Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Plasminogen Activator Inhibitor-1 (Serpin E1 / PAI-1) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
measure: Salivary Tumour Necrosis Factor alpha (TNF alpha) Concentration
timeFrame: twice: before intervention (at 0 months) and after intervention (at 3 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University of Sharjah
Study officials:
References: