Overweight and Obesity in Preschoolers

Not Applicable

Active, not recruiting

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Standard care; Behavioral: Parent group; Behavioral: mHealth component

• Registration Number: NCT03800823
• Lead Sponsor: 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).

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.

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-11
• Study Start: 2019-02-15
• Primary Completion: 2022-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Standard care for overweight and obesity
Parent group & mHealth component	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.
Parent group & mHealth component	Parent group	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.

Primary Outcome Measures

Name	Time	Method
Change in body mass index (BMI) z-score.	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

Name	Time	Method
Physical activity and sedentary behaviour	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.
Food intake	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.
Waist circumference	Baseline, 10 weeks, 9 months, 15 months, 21 months	Measured at the mid-point between the lower rib and iliac crest.
Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals	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.
Epigenetic and metabolic markers	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.
Eating behaviour	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.
Parenting behaviour	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'.

Trial Locations

Locations (3)

University of Medicine and Pharmacy "Victor Babes"; 🇷🇴 Timişoara, Romania

Karolinska Instituet; 🇸🇪 Huddinge, Sweden

University of the Balearic Islands & CIBEROBN; 🇪🇸 Palma De Mallorca, Spain