An interventional study of 1-year dietary and physical activity intervention of childhood obesity in Childhood Obesity, sponsored by Helsinki University Central Hospital. Active, not recruiting at 1 site in Finland. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
The aim of this study is to evaluate the effects of lifestyle intervention on the management of childhood overweight and to explore the factors that contribute to the outcome, as well as the costs for the health care system. The hypotheses of the study are that lifestyle intervention is efficient in reducing BMI-SDS and thus effective in preventing overweight to progress to obesity, and it is also cost effective.
The research is necessary for the development of overweight treatment, and try to find out the optimal duration and intensity for the treatment and content useful for clinical work.
Methods and analyses: The aim of this study is to recruit 80 children and to randomize them either to an intervention group or a control group with standard care. Intervention group receive intensive, family-based diet and physical activity counseling, deliver by a multidisciplinary team of a pediatrician, a nurse and a clinical nutritionist. Control group do not receive any lifestyle intervention during the study. The inclusion criteria are weight-for-height ≥+40% or ≥+30% and increasing and age of 6-12 years. All participants fill out the study questionnaires and plasma samples are taken at baseline and at 12 months. Outcome variables will be compared between intervention and control groups.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 80 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
weight for height at least + 40 % or ≥ 30 % and it is rising
Exclusion Criteria:
Clinical diagnosis of endocrine or mental diseases.
The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. The multidisciplinary team consists of one pediatrician, one specialist nurse and a clinical nutritionist. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time. The treatment is based on educational and behavioural counselling and motivating the participants to change their lifestyle and to support the parents in managing their children´s behaviour. The aim of counselling is to increase awareness of healthy dietary and physical activity habits; to achieve a suitable energy balance, to create a positive attitude to physical activity, to promote optimal sleep duration and to improve the children´s body image and body control.
Procedure: 1-year dietary and physical activity intervention of childhood obesity
Participants in the control group continue with the standard care in primary care and do not receive any special lifestyle intervention during the study.
The 1-year lifestyle intervention includes intensive, family-based diet and physical activity counselling. Children with their parents meet the pediatrician two times, the specialist nurse five times and the clinical nutritionist three times during the 1-year intervention. One of the meetings with the clinical nutritionist is only for parents and the child is with the nurse at the same time. The participants in the intervention group are advised and motivated to increase their regular daily physical activity and to reduce sedentary habits. They have one group session for the training in the gymnasium with physical education instructor. The physical education instructor gives a voluntary lecture for parents about increasing physical activity and reducing sedentary time.
To investigate the efficacy of the intervention for the ISO-BMI
How much ISO-BMI change during the intervention (kg/m2)
Time frame: 12 months
The costs of the intervention for the health care system
Investigators calculate the costs (euros) of the intervention (the price of research visits, laboratory tests, the salary of emplyees and the cost of research rooms).
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital