Overweight and Obesity in Preschoolers

Obesity Clinical Trial

— MLEurope  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03800823
• Other study ID #: 774548-WP8
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.
• Standard care
Standard care for overweight and obesity.

Locations

Country	Name	City	State
Romania	University of Medicine and Pharmacy "Victor Babes"	Timisoara
Spain	University of the Balearic Islands & CIBEROBN	Palma De Mallorca
Sweden	Karolinska Instituet	Huddinge

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	El Centro de Investigación Biomédica en Red, CIBER, University of Medicine and Pharmacy "Victor Babes" Timisoara

Countries where clinical trial is conducted

Romania,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 10 weeks, 9 months, 15 months, 21 months
Secondary	Waist circumference	Measured at the mid-point between the lower rib and iliac crest.	Baseline, 10 weeks, 9 months, 15 months, 21 months
Secondary	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.	Baseline, 9 months, 15 months, 21 months
Secondary	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'.	Baseline, 9 months, 15 months, 21 months
Secondary	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.	Baseline, 9 months
Secondary	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.	Baseline, 9 months
Secondary	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.	Baseline, 9 months
Secondary	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.	Baseline, 4 months