Effect of Smart Phone Delivered Health Education Intervention on Overweight and Obese Schoolchildren's Dietary Habits and Body Composition in the UAE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese children (over 2 SD based on the WHO Growth Reference (2007)).
- •Between 8 - 12 years old.
- •Attending school in Sharjah, UAE.
排除标准
- •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.
结局指标
主要结局
Weight
时间窗: 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
Body Mass Index
时间窗: 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
Children's Physical Activity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
Body Fat Mass
时间窗: 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
时间窗: 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
时间窗: twice: before intervention (at 0 months) and after intervention (at 3 months).
Using a valid Nutrition Knowledge Attitude Practice Questionnaire - no scale
Salivary Tumour Necrosis Factor alpha (TNF alpha) Concentration
时间窗: 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)
Height
时间窗: 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
Total Body Water
时间窗: 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
Salivary Adiponectin (Acrp30) Concentration
时间窗: 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
时间窗: 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)
Children's Dietary Intake
时间窗: 3 times: before intervention (at 0 months), after intervention (at 3 months), after maintenance (at 5 months)
Using 24 Hours' Diet recall (3 days).
Salivary Resistin Concentration
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Heba Mustafaalsaafin
Principal Investigator
Universiti Sains Malaysia