Abstract
OBJECTIVE: To compare a new comprehensive lifestyle programme performed in groups of families with overweight (included obese) children with a more conventional single-family programme. The study design and interim anthropometrical results after 12 months are presented. DESIGN: Altogether 97 overweight and obese children aged 6-12 years with body mass index (BMI) corresponding to cut-off point ≥ 27.5 in adults were included. Study participants were randomised to multiple-family intervention (MUFI) or single-family intervention (SIFI) in a parallel design. MUFI comprised a 3-day inpatient programme at the hospital with other families and a multidisciplinary team, follow-up visits in their hometown individually and in groups, organised physical activity twice weekly and a 4-day family camp after 6 months. SIFI comprised individual counselling by paediatric nurse, paediatric consultant and nutritionist at the hospital and follow-up by public health nurse in the community. Solution focused approach was applied in both interventions. Primary outcome measures were change in BMI kg/m(2) and BMI SD score (BMI SDS). RESULTS: BMI increased by 0.37 units in the MUFI compared to 0.77 units in the SIFI (p=0.18). BMI SDS decreased by 0.16 units in the MUFI group compared to 0.07 units in the SIFI group (p=0.07). Secondary endpoint waist circumference decreased 0.94 cm in the multiple-family group and increased 0.95 cm in the single-family group, p=0.04. CONCLUSIONS: Interim analysis after 12 months showed no between-group difference in terms of BMI or BMI SDS. The MUFI group had a significant decrease in waist circumference compared to the SIFI group. THE TRIAL IS REGISTERED: at http://www.clinicaltrials.gov (NCT00872807).