<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/NCT03800823</url>
  </required_header>
  <id_info>
    <org_study_id>774548-WP8</org_study_id>
    <nct_id>NCT03800823</nct_id>
  </id_info>
  <brief_title>Overweight and Obesity in Preschoolers</brief_title>
  <acronym>MLEurope</acronym>
  <official_title>A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Medicine and Pharmacy &quot;Victor Babes&quot; Timisoara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>El Centro de Investigación Biomédica en Red, CIBER</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity interventions in early childhood are recommended as they have been proven to be more&#xD;
      effective than interventions later in life. The overall aim of this study is to assess the&#xD;
      effectiveness, feasibility, and acceptance of an overweight and obesity intervention in&#xD;
      socially disadvantaged families. Participants will be families with children aged 2-6 years&#xD;
      (n = 300) with overweight or obesity and will be recruited from three sites: Stockholm,&#xD;
      Sweden (n = 100); Timisoara, Romania (n = 100); and Mallorca, Spain (n = 100).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed randomized controlled trial has five specific aims:&#xD;
&#xD;
      Specific Aim 1: To determine the effectiveness of a 10 week parent-only group support program&#xD;
      focusing on evidence-based parenting practices followed by a mobile health (mHealth)&#xD;
      component for 6-months (n = 150) compared to standard care (n = 150) for overweight and&#xD;
      obesity in pre-school children (change in BMI z-scores after 9 months primary outcome).&#xD;
&#xD;
      Specific Aim 2: To determine if the intervention can improve body composition (waist&#xD;
      circumference), child eating behaviour, physical activity, and parental feeding practices in&#xD;
      comparison to the control group.&#xD;
&#xD;
      Specific Aim 3: To assess reversibility of the molecular signatures of obesity following the&#xD;
      intervention through epigenetic markers in white blood cells (methylation) and analyzing the&#xD;
      role of the gut hormones.&#xD;
&#xD;
      Specific Aim 4: To assess and validate child food intake with metabolic markers in urine.&#xD;
&#xD;
      Specific Aim 5: To evaluate the feasibility of recruitment (facilitators and barriers),&#xD;
      attrition and acceptability, as well as patient and caregiver satisfaction to the&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body mass index (BMI) z-score.</measure>
    <time_frame>Baseline, 10 weeks, 9 months, 15 months, 21 months</time_frame>
    <description>It is the most commonly used indicator of changes in weight status in pediatric obesity studies and enable comparison between other studies. The children's weight and height will be measured using standardized procedures and BMI z-scores will be derived from Swedish age and gender specific reference values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline, 10 weeks, 9 months, 15 months, 21 months</time_frame>
    <description>Measured at the mid-point between the lower rib and iliac crest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating behaviour</measure>
    <time_frame>Baseline, 9 months, 15 months, 21 months</time_frame>
    <description>Measured using the Child Eating Behaviour Questionnaire (CEBQ). It includes 35 items on eating styles comprising eight factors related to obesity risk. Parents rate each behavior on a five-point Likert scale. It is a 5-point response scale (''never, rarely, sometimes, mostly, always'' for Items 1-13, and ''disagree, slightly disagree, neutral, slightly agree, agree'' for items 14-49). Mean scores for each subscale will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting behaviour</measure>
    <time_frame>Baseline, 9 months, 15 months, 21 months</time_frame>
    <description>Measured using the Comprehensive Feeding Practices Questionnaire (CFPQ). The CFPQ is a parent-report instrument, designed to measure feeding practices of parents of 2-to-8- year-old children. It contains 49 items comprising 12 factors: 'Encourage Balance and Variety', 'Environment', 'Involvement', 'Modeling', 'Monitoring', 'Teaching about Nutrition', 'Emotion Regulation', 'Food as Reward', 'Pressure', 'Child Control', 'Restriction for Health' and 'Restriction for Weight Control'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity and sedentary behaviour</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>Assessed over 7 consecutive days using the ActiGraph wGT3x-BT accelerometer. Children will wear the ActiGraph on the non-dominant wrist 24hrs per day. Parents/caregivers will record when the device has been taken on and off and the activities performed during that time as well as when the child went to bed and woke up. The recorded movements will be used to estimate time in various activity levels (e.g., sedentary behavior, light physical activity etc.) by means of cut-offs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>First void urinary sample from the child will be collected to assess child food intake. Urine samples will be assessed by proton nuclear magnetic resonance (1H-NMR) spectroscopy. Diet-discriminatory metabolites will be identified so that urine metabolite models can be developed and validated against 24 hour recall data and a food diary for children that attend preschool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epigenetic and metabolic markers</measure>
    <time_frame>Baseline, 9 months</time_frame>
    <description>Fasting blood samples will be collected to assess reversibility of metabolic markers through epigenetic markers and the role of gut hormones. The epigenetic analysis will be carried out in white blood cells, which will required DNA extraction, bisulphite transformation and analysis with specific PCRs or other technologies involving hypothesis-driven CpGs. The unit of measurement/criteria will be changes in percentage of methylation (CpGs). These measurements will be related to other measurements, i.e.: metabolomics and anthropometric measurements. With all the measurements (anthropometrical, and biochemical/genomics) the final purpose would be to build a predictive score of changes related to weight status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals</measure>
    <time_frame>Baseline, 4 months</time_frame>
    <description>In this qualitative assesment using semi-structured interviews we will thoroughly assess facilitators and barriers of recruitment as well as attrition to the intervention and feasibility and acceptability of the care offered. Both parents and health care professionals will be interviewed by trained staff in the research group post intervention. The interviews are recorded and fully transcribed before they are coded and analyzed using thematic analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Parent group &amp; mHealth component</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention in the present study is a 10 week parent training group session (More and Less Program) followed by a 6-month mobile phone based intervention. Both components aim to develop healthy lifestyle behaviours regarding dietary habits and physical activity in 2-6 year olds. The intervention is delivered towards the parents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care for overweight and obesity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent group</intervention_name>
    <description>In group sessions parents will learn how to use positive parenting practices (e.g., encouragement and limit setting) instead of ineffective practices (e.g., coercive behaviour, negative reciprocity). Using a parent group approach, each of the 10 sessions consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments.</description>
    <arm_group_label>Parent group &amp; mHealth component</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mHealth component</intervention_name>
    <description>After the group sessions, parents will receive a 6-month mHealth program (MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet/physical activity behaviours. The program includes information, advice, and strategies to change unhealthy behaviours and the possibility to register the child's intake of fruit, vegetables, candy, sweetened beverages, and sedentary time.</description>
    <arm_group_label>Parent group &amp; mHealth component</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Standard care for overweight and obesity.</description>
    <arm_group_label>Standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 to 6 year old children with overweight or obesity according to international&#xD;
             cut-offs.&#xD;
&#xD;
          -  Children who have no other underlying medical condition(s).&#xD;
&#xD;
          -  Parent(s) who have the ability to communicate in Swedish (for the Swedish part),&#xD;
             Romanian (for the Romanian part), and Spanish (for the Spanish part).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent(s) not owning a smartphone compatible with the MINISTOP app.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paulina Nowicka</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Medicine and Pharmacy &quot;Victor Babes&quot;</name>
      <address>
        <city>Timişoara</city>
        <zip>30041</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Balearic Islands &amp; CIBEROBN</name>
      <address>
        <city>Palma De Mallorca</city>
        <zip>07122</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Instituet</name>
      <address>
        <city>Huddinge</city>
        <zip>14157</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
    <country>Spain</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Paulina Nowicka</investigator_full_name>
    <investigator_title>Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Obesity</keyword>
  <keyword>Treatment</keyword>
  <keyword>Family</keyword>
  <keyword>mHealth</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>
  <!-- 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/NCT03800823
org study id: 774548-WP8
nct id: NCT03800823
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity interventions in early childhood are recommended as they have been proven to be more
      effective than interventions later in life. The overall aim of this study is to assess the
      effectiveness, feasibility, and acceptance of an overweight and obesity intervention in
      socially disadvantaged families. Participants will be families with children aged 2-6 years
      (n = 300) with overweight or obesity and will be recruited from three sites: Stockholm,
      Sweden (n = 100); Timisoara, Romania (n = 100); and Mallorca, Spain (n = 100).
The proposed randomized controlled trial has five specific aims:

      Specific Aim 1: To determine the effectiveness of a 10 week parent-only group support program
      focusing on evidence-based parenting practices followed by a mobile health (mHealth)
      component for 6-months (n = 150) compared to standard care (n = 150) for overweight and
      obesity in pre-school children (change in BMI z-scores after 9 months primary outcome).

      Specific Aim 2: To determine if the intervention can improve body composition (waist
      circumference), child eating behaviour, physical activity, and parental feeding practices in
      comparison to the control group.

      Specific Aim 3: To assess reversibility of the molecular signatures of obesity following the
      intervention through epigenetic markers in white blood cells (methylation) and analyzing the
      role of the gut hormones.

      Specific Aim 4: To assess and validate child food intake with metabolic markers in urine.

      Specific Aim 5: To evaluate the feasibility of recruitment (facilitators and barriers),
      attrition and acceptability, as well as patient and caregiver satisfaction to the
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in body mass index (BMI) z-score.
time frame: Baseline, 10 weeks, 9 months, 15 months, 21 months
description: It is the most commonly used indicator of changes in weight status in pediatric obesity studies and enable comparison between other studies. The children's weight and height will be measured using standardized procedures and BMI z-scores will be derived from Swedish age and gender specific reference values.
measure: Waist circumference
time frame: Baseline, 10 weeks, 9 months, 15 months, 21 months
description: Measured at the mid-point between the lower rib and iliac crest.
measure: Eating behaviour
time frame: Baseline, 9 months, 15 months, 21 months
description: Measured using the Child Eating Behaviour Questionnaire (CEBQ). It includes 35 items on eating styles comprising eight factors related to obesity risk. Parents rate each behavior on a five-point Likert scale. It is a 5-point response scale (''never, rarely, sometimes, mostly, always'' for Items 1-13, and ''disagree, slightly disagree, neutral, slightly agree, agree'' for items 14-49). Mean scores for each subscale will be calculated.
measure: Parenting behaviour
time frame: Baseline, 9 months, 15 months, 21 months
description: Measured using the Comprehensive Feeding Practices Questionnaire (CFPQ). The CFPQ is a parent-report instrument, designed to measure feeding practices of parents of 2-to-8- year-old children. It contains 49 items comprising 12 factors: 'Encourage Balance and Variety', 'Environment', 'Involvement', 'Modeling', 'Monitoring', 'Teaching about Nutrition', 'Emotion Regulation', 'Food as Reward', 'Pressure', 'Child Control', 'Restriction for Health' and 'Restriction for Weight Control'.
measure: Physical activity and sedentary behaviour
time frame: Baseline, 9 months
description: Assessed over 7 consecutive days using the ActiGraph wGT3x-BT accelerometer. Children will wear the ActiGraph on the non-dominant wrist 24hrs per day. Parents/caregivers will record when the device has been taken on and off and the activities performed during that time as well as when the child went to bed and woke up. The recorded movements will be used to estimate time in various activity levels (e.g., sedentary behavior, light physical activity etc.) by means of cut-offs.
measure: Food intake
time frame: Baseline, 9 months
description: First void urinary sample from the child will be collected to assess child food intake. Urine samples will be assessed by proton nuclear magnetic resonance (1H-NMR) spectroscopy. Diet-discriminatory metabolites will be identified so that urine metabolite models can be developed and validated against 24 hour recall data and a food diary for children that attend preschool.
measure: Epigenetic and metabolic markers
time frame: Baseline, 9 months
description: Fasting blood samples will be collected to assess reversibility of metabolic markers through epigenetic markers and the role of gut hormones. The epigenetic analysis will be carried out in white blood cells, which will required DNA extraction, bisulphite transformation and analysis with specific PCRs or other technologies involving hypothesis-driven CpGs. The unit of measurement/criteria will be changes in percentage of methylation (CpGs). These measurements will be related to other measurements, i.e.: metabolomics and anthropometric measurements. With all the measurements (anthropometrical, and biochemical/genomics) the final purpose would be to build a predictive score of changes related to weight status.
measure: Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals
time frame: Baseline, 4 months
description: In this qualitative assesment using semi-structured interviews we will thoroughly assess facilitators and barriers of recruitment as well as attrition to the intervention and feasibility and acceptability of the care offered. Both parents and health care professionals will be interviewed by trained staff in the research group post intervention. The interviews are recorded and fully transcribed before they are coded and analyzed using thematic analysis.
arm group label: Parent group & mHealth component
arm group type: Experimental
description: The intervention in the present study is a 10 week parent training group session (More and Less Program) followed by a 6-month mobile phone based intervention. Both components aim to develop healthy lifestyle behaviours regarding dietary habits and physical activity in 2-6 year olds. The intervention is delivered towards the parents.
arm group label: Standard care
arm group type: Active Comparator
description: Standard care for overweight and obesity
intervention type: Behavioral
intervention name: Parent group
description: In group sessions parents will learn how to use positive parenting practices (e.g., encouragement and limit setting) instead of ineffective practices (e.g., coercive behaviour, negative reciprocity). Using a parent group approach, each of the 10 sessions consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments.
arm group label: Parent group & mHealth component
intervention type: Behavioral
intervention name: mHealth component
description: After the group sessions, parents will receive a 6-month mHealth program (MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet/physical activity behaviours. The program includes information, advice, and strategies to change unhealthy behaviours and the possibility to register the child's intake of fruit, vegetables, candy, sweetened beverages, and sedentary time.
arm group label: Parent group & mHealth component
intervention type: Behavioral
intervention name: Standard care
description: Standard care for overweight and obesity.
arm group label: Standard care
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Paulina Nowicka
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
facility: 
country: Romania
country: Spain
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Paulina Nowicka
investigator title: Senior Researcher
mesh term: Obesity
mesh term: Overweight