Adapted Cognitive Behavioral Approach to Addressing Overweight and Obesity Among Qatari Youth
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|ClinicalTrials.gov Identifier: NCT02972164|
Recruitment Status : Completed
First Posted : November 23, 2016
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Weight loss program for school children||Not Applicable|
The specific objectives of the project are to:
- Adapt and pilot a school-based intervention that combines behavioral and cognitive approaches to promote healthy lifestyle among 9-12 year old children in select Qatari schools in the first year;
- Integrate behavioral economics and cognitive behavioral therapy (MINDSPACE) in a multi-cohort prevention/intervention study targeting at risk Qatari school children at the vulnerable age range of 9-12;
- Select and use technological tools for enhanced outcomes and adoption of the intervention nationally;
- Package study findings into a lifestyle change intervention for national implementation in collaboration with Hamad Medical Corporation and the Supreme Education Council.
Data from this project could provide the basis for a national program to stem the rise of obesity in Qatar through lifestyle changes and reduce related health conditions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||799 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adapted Cognitive Behavioural Approach to Addressing Overweight and Obesity Among Qatari Youth|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||March 2018|
No Intervention: Control
Each year, 100 school children age 9-12 who meet inclusion criteria are selected from 5 randomly chosen schools to participate in the control group. Control children are assessed for the same measures as the intervention group at the beginning and end of the intervention but receive none of the intervention modules.
Experimental: Weight loss program for school children
Each year, 100 school children age 9-12 who meet inclusion criteria are selected from 5 randomly chosen schools to participate in the intervention group. The intervention children take part in the integrated approach for weight management consisting of (1) intensive weight loss camp (2) twelve weeks of after school clubs for consolidation purposes, and (3) social media and wearable sensors for support and monitoring.
Behavioral: Weight loss program for school children
The intervention involves developing social and emotional competences, promotion of healthy lifestyle, use of activity monitoring devices to promote increased activity and enlisting family to maintain weight loss in the long term.
The intervention group receives all program components: 1. Parent information sessions and orientation, 2. Two week intensive weight loss and lifestyle education camp, 3. after school clubs for consolidation (including physical activity and lifestyle education), and 4. wearable sensors and social media modules with parental involvement. Assessed outcomes include pre- and post-measurement at each phase included: weight, height, BMI, waist circumference, blood pressure, physical activity, dietary intakes, self-esteem, and subjective well-being.
Other Name: Cognitive Behavioural and lifestyle
- Weight loss [ Time Frame: 26 weeks ]Weight loss will be assessed by measurement of Body Mass Index (BMI, expressed in kg/m^2, weight in kilograms, height in meters) at baseline (Day 1 of week 1), post camp (week 3), post clubs (week 14), and post maintenance/end of intervention (week 26). Change in BMI Standard Deviation Scores (SDS) between baseline and week 26 will be used as indicator of effectiveness of intervention compared to BMI-SDS for the control group. One year follow up of change in BMI-SDS for intervention and control groups will gauge the long term benefits of the intervention. A multilevel mixed effects model will be used to assess both individual- (fixed effects) and school-level (random) effects, including covariates, such as demographic factors of the children and time (cohort). BMI SDS will be evaluated to determine mean differences and the proportions of children with significant changes in BMI-SDS throughout the course of the study. Subgroup analyses will be conducted by gender and age.
- Adoption of healthier dietary habits [ Time Frame: 26 weeks ]This will be measured by administration of a dietary intakes/habits questionnaire using the Children's Dietary Questionnaire at baseline and end of intervention (week 26). The same questionnaire will be administered to the control group for inferential purposes.
- Increased physical activity patterns [ Time Frame: 26 weeks ]Increased physical activity patterns will be assessed through administration of Physical Activity Questionnaire (PAQ-C) at baseline and end of intervention (week 26). The same questionnaire will be administered to the control group for inferential purposes.
- Improvement in self-esteem [ Time Frame: 26 weeks ]Self-esteem will be assessed using Rosemberg self-esteem scale at baseline and end of intervention (week 26). The same questionnaire will be administered to the control group for inferential purposes.
- Change in impulsivity [ Time Frame: 26 weeks ]Changes in impulsivity and subjective wellbeing will be measured using CANTAB Stop Signal Task system at baseline and end of intervention (week 26). The same questionnaire will be administered to the control group for inferential purposes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972164
|Doha, Qatar, 2713|
|Principal Investigator:||Mohamed Ahmedna, PhD||Qatar University|