- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972164
Adapted Cognitive Behavioral Approach to Addressing Overweight and Obesity Among Qatari Youth
Adapted Cognitive Behavioural Approach to Addressing Overweight and Obesity Among Qatari Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Doha, Qatar, 2713
- Qatar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- School children within age range of 9-12 yrs, at or above 95th percentile of BMI by age using International Obesity TaskForce (IOTF) cut off, and parental consent.
Exclusion Criteria:
- Psychiatric or neurological disorders, learning disability, dyslexia, current or past drug abuse, head injury and psychotropic medication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Weight loss
Time Frame: 26 weeks
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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.
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26 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adoption of healthier dietary habits
Time Frame: 26 weeks
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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.
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26 weeks
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Increased physical activity patterns
Time Frame: 26 weeks
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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.
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26 weeks
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Improvement in self-esteem
Time Frame: 26 weeks
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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.
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26 weeks
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Change in impulsivity
Time Frame: 26 weeks
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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.
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26 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohamed Ahmedna, PhD, Qatar University
Publications and helpful links
General Publications
- Vlaev I, Taylor MJ, Taylor D, Gately P, Gunn LH, Abeles A, Kerkadi A, Lothian J, Jreige SK, Alsaadi A, Al-Kuwari MG, Ghuloum S, Al-Kuwari H, Darzi A, Ahmedna M. Testing a multicomponent lifestyle intervention for combatting childhood obesity. BMC Public Health. 2021 Apr 29;21(1):824. doi: 10.1186/s12889-021-10838-1.
- Fernandez-Luque L, Singh M, Ofli F, Mejova YA, Weber I, Aupetit M, Jreige SK, Elmagarmid A, Srivastava J, Ahmedna M. Implementing 360 degrees Quantified Self for childhood obesity: feasibility study and experiences from a weight loss camp in Qatar. BMC Med Inform Decis Mak. 2017 Apr 13;17(1):37. doi: 10.1186/s12911-017-0432-6. Erratum In: BMC Med Inform Decis Mak. 2017 May 12;17 (1):62.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X - 036 - 3 - 013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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