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Completed

NCT Number: NCT06247202

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

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sharjah

Sharjah city, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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).

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

  • University of Sharjah

Registry information

Official study title

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

Acronym: mHealth

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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