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ObesityMLEuropeNCT03800823

Overweight and Obesity in Preschoolers

A study testing Parent group and mHealth component in people with Obesity and Overweight, run by Karolinska Institutet at 3 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Parent group and mHealth component
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesin 3 countries
Study dates
15 Feb 2019to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Romania1 site

  • University of Medicine and Pharmacy "Victor Babes"

    Timișoara, 30041

Other trials in Romania

Spain1 site

  • University of the Balearic Islands & CIBEROBN

    Palma de Mallorca, 07122

Other trials in Spain

Sweden1 site

  • Karolinska Instituet

    Huddinge, 14157

Other trials in Sweden

About this study

Official title: A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe

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).

Read the 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.

Conditions
Obesity, Overweight
Being tested
Parent group, mHealth component, Standard care
Keywords
Children, Obesity, Treatment, Family, mHealth
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent groupBehavioural

    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.

  • mHealth componentBehavioural

    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.

  • Standard careBehavioural

    Standard care for overweight and obesity.

Study groups in NCT03800823
Study groupRoleWhat they receive
Parent group & mHealth componentExperimentalThe 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.
Receives: Behavioral: Parent group; Behavioral: mHealth component
Standard careActive comparatorStandard care for overweight and obesity
Receives: Behavioral: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body mass index (BMI) z-score.

    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.

    Measured: Baseline, 10 weeks, 9 months, 15 months, 21 months

Secondary outcomes (7)

  1. Waist circumference

    Measured at the mid-point between the lower rib and iliac crest.

    Measured: Baseline, 10 weeks, 9 months, 15 months, 21 months

  2. Eating behaviour

    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.

    Measured: Baseline, 9 months, 15 months, 21 months

  3. Parenting behaviour

    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'.

    Measured: Baseline, 9 months, 15 months, 21 months

  4. Physical activity and sedentary behaviour

    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.

    Measured: Baseline, 9 months

  5. Food intake

    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.

    Measured: Baseline, 9 months

  6. Epigenetic and metabolic markers

    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.

    Measured: Baseline, 9 months

  7. Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals

    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.

    Measured: Baseline, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2019
  2. Study start15 Feb 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03800823
Sponsor's protocol ID
774548-WP8
Acronym
MLEurope
Status last verified
Oct 2024
First submitted
2 Jan 2019
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eli K, Neovius C, Nordin K, Brissman M, Ek A. Parents' experiences following conversations about their young child's weight in the primary health care setting: a study within the STOP project. BMC Public Health. 2022 Aug 12;22(1):1540. doi: 10.1186/s12889-022-13803-8.

    PubMed 35962359

  • Serban CL, Putnoky S, Ek A, Eli K, Nowicka P, Chirita-Emandi A. Making Childhood Obesity a Priority: A Qualitative Study of Healthcare Professionals' Perspectives on Facilitating Communication and Improving Treatment. Front Public Health. 2021 Jul 15;9:652491. doi: 10.3389/fpubh.2021.652491. eCollection 2021.

    PubMed 34336760

  • Sjunnestrand M, Nordin K, Eli K, Nowicka P, Ek A. Planting a seed - child health care nurses' perceptions of speaking to parents about overweight and obesity: a qualitative study within the STOP project. BMC Public Health. 2019 Nov 9;19(1):1494. doi: 10.1186/s12889-019-7852-4.

    PubMed 31706318

  • Ek A, Delisle Nystrom C, Chirita-Emandi A, Tur JA, Nordin K, Bouzas C, Argelich E, Martinez JA, Frost G, Garcia-Perez I, Saez M, Paul C, Lof M, Nowicka P. A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project. BMC Public Health. 2019 Jul 15;19(1):945. doi: 10.1186/s12889-019-7161-y.

    PubMed 31307412

Questions about this trial

What is this clinical trial studying?

A study testing Parent group and mHealth component in people with Obesity and Overweight, run by Karolinska Institutet at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Romania, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body mass index (BMI) z-score. (time frame: Baseline, 10 weeks, 9 months, 15 months, 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03800823, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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