NCT02972164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
799

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

4.1 years

First QC Date

November 14, 2016

Last Update Submit

April 6, 2018

Conditions

Keywords

Childhood obesityLifestylePreventionInterventionBehavioural psychology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Adoption of healthier dietary habits

    26 weeks

  • Increased physical activity patterns

    26 weeks

  • Improvement in self-esteem

    26 weeks

  • Change in impulsivity

    26 weeks

Study Arms (2)

Control

NO INTERVENTION

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.

Weight loss program for school children

EXPERIMENTAL

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

Interventions

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.

Also known as: Cognitive Behavioural and lifestyle
Weight loss program for school children

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Psychiatric or neurological disorders, learning disability, dyslexia, current or past drug abuse, head injury and psychotropic medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qatar University

Doha, 2713, Qatar

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

ObesityPediatric Obesity

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PromotionHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mohamed Ahmedna, PhD

    Qatar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 23, 2016

Study Start

August 1, 2013

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

April 10, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations