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Overweight and Obesity in Preschoolers (MLEurope)

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ClinicalTrials.gov Identifier: NCT03800823
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
University of Medicine and Pharmacy "Victor Babes" Timisoara
El Centro de Investigación Biomédica en Red, CIBER
Information provided by (Responsible Party):
Paulina Nowicka, Karolinska Institutet

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Parent group Behavioral: mHealth component Behavioral: Standard care Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

Arm Intervention/treatment
Experimental: Parent group & mHealth component
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.
Behavioral: Parent group
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.

Behavioral: mHealth component
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.

Active Comparator: Standard care
Standard care for overweight and obesity
Behavioral: Standard care
Standard care for overweight and obesity.




Primary Outcome Measures :
  1. Change in body mass index (BMI) z-score. [ Time Frame: Baseline, 10 weeks, 9 months, 15 months, 21 months ]
    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.


Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: Baseline, 10 weeks, 9 months, 15 months, 21 months ]
    Measured at the mid-point between the lower rib and iliac crest.

  2. Eating behaviour [ Time Frame: Baseline, 9 months, 15 months, 21 months ]
    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.

  3. Parenting behaviour [ Time Frame: Baseline, 9 months, 15 months, 21 months ]
    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'.

  4. Physical activity and sedentary behaviour [ Time Frame: Baseline, 9 months ]
    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.

  5. Food intake [ Time Frame: Baseline, 9 months ]
    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.

  6. Epigenetic and metabolic markers [ Time Frame: Baseline, 9 months ]
    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.

  7. Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals [ Time Frame: Baseline, 4 months ]
    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.



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2 to 6 year old children with overweight or obesity according to international cut-offs.
  • Children who have no other underlying medical condition(s).
  • Parent(s) who have the ability to communicate in Swedish (for the Swedish part), Romanian (for the Romanian part), and Spanish (for the Spanish part).

Exclusion Criteria:

  • Parent(s) not owning a smartphone compatible with the MINISTOP app.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800823


Contacts
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Contact: Anna Ek, PhD 0736208363 anna.ek@ki.se

Locations
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Romania
University of Medicine and Pharmacy "Victor Babes" Recruiting
Timişoara, Romania, 30041
Contact: Adela Chirita, MD       adela.chirita@umft.ro   
Spain
University of the Balearic Islands & CIBEROBN Not yet recruiting
Palma De Mallorca, Spain, 07122
Contact: Josep A Tur Marí, PhD       pep.tur@uib.es   
Sweden
Karolinska Instituet Recruiting
Huddinge, Sweden, 14157
Contact: Anna Ek, PhD       anna.ek@ki.se   
Sponsors and Collaborators
Karolinska Institutet
University of Medicine and Pharmacy "Victor Babes" Timisoara
El Centro de Investigación Biomédica en Red, CIBER
Investigators
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Principal Investigator: Paulina Nowicka Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulina Nowicka, Senior Researcher, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03800823     History of Changes
Other Study ID Numbers: 774548-WP8
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paulina Nowicka, Karolinska Institutet:
Children
Obesity
Treatment
Family
mHealth
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms