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Adapted Cognitive Behavioral Approach to Addressing Overweight and Obesity Among Qatari Youth

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Weight loss program for school children
Sponsored by
Qatar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Childhood obesity, Lifestyle, Prevention, Intervention, Behavioural psychology

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Qatar University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Weight loss program for school children

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight loss
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.

Secondary Outcome Measures

Adoption of healthier dietary habits
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
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
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
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.

Full Information

First Posted
November 14, 2016
Last Updated
April 6, 2018
Sponsor
Qatar University
Collaborators
Imperial College London, Hamad Medical Corporation, Supreme Council Of Health, Qatar, Aspetar, Leeds Beckett University
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1. Study Identification

Unique Protocol Identification Number
NCT02972164
Brief Title
Adapted Cognitive Behavioral Approach to Addressing Overweight and Obesity Among Qatari Youth
Official Title
Adapted Cognitive Behavioural Approach to Addressing Overweight and Obesity Among Qatari Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qatar University
Collaborators
Imperial College London, Hamad Medical Corporation, Supreme Council Of Health, Qatar, Aspetar, Leeds Beckett University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Levels of overweight and obesity have reached alarming proportions in Qatar and other Gulf nations. In Qatar, the need to establish national strategies for the prevention and treatment of obesity has been recognized in the new Qatar National Health Strategy 2011-2016, which stresses the need for prevention. In fact, the Qatar National Nutrition and Physical Activity Action Plan 2011-2016 calls for nutrition and physical activity interventions for the prevention of obesity and related chronic diseases such as diabetes. The treatment and prevention of childhood obesity is largely through lifestyle changes- encouraging health eating and physical activity and discouraging sedentary behavior. However, changing such behaviors is complex and requires a combination of integrated approaches to tackle such a multifaceted problem. Herein, the investigators set out to implement and evaluate a novel weight management program for Qatari school children at the vulnerable age of 9-12 years. The project incorporates a cognitive-behavioral approach that involves developing social and emotional competences, promotion healthy dietary habits, development of physical literacy, and use of activity monitoring devices to promote increased activity while enlisting family involvement in an attempt to maintain weight loss in the long term. This project seeks to also take things further by integrating a range of interventions that use cutting edge insights from the behavioral sciences through the use of MINDSPACE approach (MINDSPACE: Messenger, Incentive, Norms, Default, Salience, Priming, Affect, Commitment, Ego) in conjunction with technology tools for monitoring activity and providing ongoing support through the use of social media. The intervention involves a multi-cohort intervention involving 500 Qatari children over 5 years to be conducted in three phases (1) intensive weight loss camps, (2) after-school clubs as supplement/consolidation, and (3) maintenance through web and social/family support.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Childhood obesity, Lifestyle, Prevention, Intervention, Behavioural psychology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
799 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Weight loss program for school children
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss program for school children
Other Intervention Name(s)
Cognitive Behavioural and lifestyle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Adoption of healthier dietary habits
Description
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.
Time Frame
26 weeks
Title
Increased physical activity patterns
Description
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.
Time Frame
26 weeks
Title
Improvement in self-esteem
Description
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.
Time Frame
26 weeks
Title
Change in impulsivity
Description
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.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmedna, PhD
Organizational Affiliation
Qatar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qatar University
City
Doha
ZIP/Postal Code
2713
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33926412
Citation
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.
Results Reference
derived
PubMed Identifier
28403865
Citation
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.
Results Reference
derived

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Adapted Cognitive Behavioral Approach to Addressing Overweight and Obesity Among Qatari Youth

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