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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972164
• Other study ID #: X - 036 - 3 - 013
• Status: Completed
• Phase: N/A
• First received: November 14, 2016
• Last updated: April 6, 2018
• Start date: August 2013
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Qatar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The specific objectives of the project are to:

1. 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;

2. 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;

3. Select and use technological tools for enhanced outcomes and adoption of the intervention nationally;

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
Qatar	Qatar University	Doha

Sponsors (6)

Lead Sponsor	Collaborator
Qatar University	Aspetar, Hamad Medical Corporation, Imperial College London, Leeds Beckett University, Supreme Council Of Health, Qatar

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks