<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972164</url>
  </required_header>
  <id_info>
    <org_study_id>X - 036 - 3 - 013</org_study_id>
    <nct_id>NCT02972164</nct_id>
  </id_info>
  <brief_title>Adapted Cognitive Behavioral Approach to Addressing Overweight and Obesity Among Qatari Youth</brief_title>
  <official_title>Adapted Cognitive Behavioural Approach to Addressing Overweight and Obesity Among Qatari Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qatar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hamad Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Supreme Council Of Health, Qatar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aspetar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leeds Beckett University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Qatar University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Levels of overweight and obesity have reached alarming proportions in Qatar and other Gulf&#xD;
      nations. In Qatar, the need to establish national strategies for the prevention and treatment&#xD;
      of obesity has been recognized in the new Qatar National Health Strategy 2011-2016, which&#xD;
      stresses the need for prevention. In fact, the Qatar National Nutrition and Physical Activity&#xD;
      Action Plan 2011-2016 calls for nutrition and physical activity interventions for the&#xD;
      prevention of obesity and related chronic diseases such as diabetes. The treatment and&#xD;
      prevention of childhood obesity is largely through lifestyle changes- encouraging health&#xD;
      eating and physical activity and discouraging sedentary behavior. However, changing such&#xD;
      behaviors is complex and requires a combination of integrated approaches to tackle such a&#xD;
      multifaceted problem. Herein, the investigators set out to implement and evaluate a novel&#xD;
      weight management program for Qatari school children at the vulnerable age of 9-12 years. The&#xD;
      project incorporates a cognitive-behavioral approach that involves developing social and&#xD;
      emotional competences, promotion healthy dietary habits, development of physical literacy,&#xD;
      and use of activity monitoring devices to promote increased activity while enlisting family&#xD;
      involvement in an attempt to maintain weight loss in the long term. This project seeks to&#xD;
      also take things further by integrating a range of interventions that use cutting edge&#xD;
      insights from the behavioral sciences through the use of MINDSPACE approach (MINDSPACE:&#xD;
      Messenger, Incentive, Norms, Default, Salience, Priming, Affect, Commitment, Ego) in&#xD;
      conjunction with technology tools for monitoring activity and providing ongoing support&#xD;
      through the use of social media. The intervention involves a multi-cohort intervention&#xD;
      involving 500 Qatari children over 5 years to be conducted in three phases (1) intensive&#xD;
      weight loss camps, (2) after-school clubs as supplement/consolidation, and (3) maintenance&#xD;
      through web and social/family support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific objectives of the project are to:&#xD;
&#xD;
        1. Adapt and pilot a school-based intervention that combines behavioral and cognitive&#xD;
           approaches to promote healthy lifestyle among 9-12 year old children in select Qatari&#xD;
           schools in the first year;&#xD;
&#xD;
        2. Integrate behavioral economics and cognitive behavioral therapy (MINDSPACE) in a&#xD;
           multi-cohort prevention/intervention study targeting at risk Qatari school children at&#xD;
           the vulnerable age range of 9-12;&#xD;
&#xD;
        3. Select and use technological tools for enhanced outcomes and adoption of the&#xD;
           intervention nationally;&#xD;
&#xD;
        4. Package study findings into a lifestyle change intervention for national implementation&#xD;
           in collaboration with Hamad Medical Corporation and the Supreme Education Council.&#xD;
&#xD;
      Data from this project could provide the basis for a national program to stem the rise of&#xD;
      obesity in Qatar through lifestyle changes and reduce related health conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>26 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adoption of healthier dietary habits</measure>
    <time_frame>26 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased physical activity patterns</measure>
    <time_frame>26 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in self-esteem</measure>
    <time_frame>26 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in impulsivity</measure>
    <time_frame>26 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">799</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight loss program for school children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight loss program for school children</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Weight loss program for school children</arm_group_label>
    <other_name>Cognitive Behavioural and lifestyle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  School children within age range of 9-12 yrs, at or above 95th percentile of BMI by&#xD;
             age using International Obesity TaskForce (IOTF) cut off, and parental consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or neurological disorders, learning disability, dyslexia, current or past&#xD;
             drug abuse, head injury and psychotropic medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Ahmedna, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qatar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qatar University</name>
      <address>
        <city>Doha</city>
        <zip>2713</zip>
        <country>Qatar</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Qatar</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>April 6, 2018</last_update_submitted>
  <last_update_submitted_qc>April 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qatar University</investigator_affiliation>
    <investigator_full_name>Prof. Mohamed Ahmedna</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Childhood obesity</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Prevention</keyword>
  <keyword>Intervention</keyword>
  <keyword>Behavioural psychology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972164
org study id: X - 036 - 3 - 013
nct id: NCT02972164
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Weight loss
time frame: 26 weeks
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.
measure: Adoption of healthier dietary habits
time frame: 26 weeks
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.
measure: Increased physical activity patterns
time frame: 26 weeks
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.
measure: Improvement in self-esteem
time frame: 26 weeks
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.
measure: Change in impulsivity
time frame: 26 weeks
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.
arm group label: Control
arm group type: No Intervention
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 group label: Weight loss program for school children
arm group type: Experimental
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: Weight loss program for school children
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.
arm group label: Weight loss program for school children
other name: Cognitive Behavioural and lifestyle
criteria: 
gender: All
minimum age: 9 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Ahmedna, PhD
role: Principal Investigator
affiliation: Qatar University
facility: 
country: Qatar
responsible party type: Principal Investigator
investigator affiliation: Qatar University
investigator full name: Prof. Mohamed Ahmedna
investigator title: Professor
mesh term: Obesity
mesh term: Overweight
sharing ipd: No