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

NCT06247202 | Completed

• 2 other identifiers: USM/JEPeM/KK/23020205REC-22-09-05-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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. 5.Are there any significant changes in nutrition related knowledge among parents of overweight and obese school-age children after three months of intervention?

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (19)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Parents' Knowledge

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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).

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

Participants in the control group will receive paper delivered health education in the form of a one time handout.

Other: Paper Education (conventional)

Interventions

Smart Phone Education (mhealth) OTHER

Nutrition and Health Education module delivered through m-health approach (smart phones)

Intervention group

Paper Education (conventional) OTHER

Nutrition and Health Education module delivered through conventional approach (paper)

Control group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).
• Between 8 - 12 years old.
• Attending school in Sharjah, UAE.

You may not qualify if:

• Children on a specific diet.
• Children who have any chronic diseases.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• University of Sharjah: collaborator

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Telemedicine; Congresses as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Lab technician who will handle the saliva analysis and the person who will be doing the statistical analysis will be blinded of any data related to the grouping of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 7, 2024
• Study Start: December 1, 2023
• Primary Completion: March 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

AE (1)